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1.
BMC Infect Dis ; 21(1): 72, 2021 Jan 14.
Artículo en Inglés | MEDLINE | ID: covidwho-1067195

RESUMEN

BACKGROUND: Hydroxychloroquine has not been associated with improved survival among hospitalized COVID-19 patients in the majority of observational studies and similarly was not identified as an effective prophylaxis following exposure in a prospective randomized trial. We aimed to explore the role of hydroxychloroquine therapy in mildly symptomatic patients diagnosed in the outpatient setting. METHODS: We examined the association between outpatient hydroxychloroquine exposure and the subsequent progression of disease among mildly symptomatic non-hospitalized patients with documented SARS-CoV-2 infection. The primary outcome assessed was requirement of hospitalization. Data was obtained from a retrospective review of electronic health records within a New Jersey USA multi-hospital network. We compared outcomes in patients who received hydroxychloroquine with those who did not applying a multivariable logistic model with propensity matching. RESULTS: Among 1274 outpatients with documented SARS-CoV-2 infection 7.6% were prescribed hydroxychloroquine. In a 1067 patient propensity matched cohort, 21.6% with outpatient exposure to hydroxychloroquine were hospitalized, and 31.4% without exposure were hospitalized. In the primary multivariable logistic regression analysis with propensity matching there was an association between exposure to hydroxychloroquine and a decreased rate of hospitalization from COVID-19 (OR 0.53; 95% CI, 0.29, 0.95). Sensitivity analyses revealed similar associations. QTc prolongation events occurred in 2% of patients prescribed hydroxychloroquine with no reported arrhythmia events among those with data available. CONCLUSIONS: In this retrospective observational study of SARS-CoV-2 infected non-hospitalized patients hydroxychloroquine exposure was associated with a decreased rate of subsequent hospitalization. Additional exploration of hydroxychloroquine in this mildly symptomatic outpatient population is warranted.


Asunto(s)
/tratamiento farmacológico , Hidroxicloroquina/administración & dosificación , Adulto , Anciano , Femenino , Hospitalización , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , New Jersey , Pacientes Ambulatorios/estadística & datos numéricos , Estudios Retrospectivos , /genética , Índice de Severidad de la Enfermedad
2.
PLoS One ; 16(1): e0246396, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1054891

RESUMEN

Because of the constantly growing numbers of COVID-19 infections and deaths, attempts were undertaken to find drugs with anti-SARS-CoV-2 activity among ones already approved for other pathologies. In the framework of such attempts, in a number of in vitro, as well as in vivo, models it was shown that hydroxychloroquine (HCQ) has an effect against SARS-CoV-2. While there were not enough clinical data to support the use of HCQ, several countries including Russia have included HCQ in treatment protocols for infected patients and for prophylaxis. In the current non-randomized, observational study we evaluated the SARS-CoV-2 RNA in nasopharynx swabs from infected patients 7-10 days post symptoms with clinically mild disease and compared the viral RNA load dynamics between patients receiving HCQ (200 mg twice per day according to the Ministry of Health of Russian Federation treatment instructions, n = 33) and a control group without antiviral pharmacological therapy (n = 12). We found a statistically significant relationship between maximal RNA quantity and deterioration of patients' medical conditions, and as well we confirmed arterial hypertension to be a risk factor for people with COVID-19. However, we showed that at the dose used in the study HCQ therapy neither shortened the viral shedding period nor reduced the virus RNA load.


Asunto(s)
/tratamiento farmacológico , Hidroxicloroquina/administración & dosificación , Carga Viral , /epidemiología , Humanos , Nasofaringe/virología , ARN Viral/análisis , ARN Viral/genética , Federación de Rusia/epidemiología , Índice de Severidad de la Enfermedad
3.
Monaldi Arch Chest Dis ; 90(4)2020 Dec 23.
Artículo en Inglés | MEDLINE | ID: covidwho-1042105

RESUMEN

We report the case of a man affected by cystic fibrosis who developed a severe SARS-CoV-2 related pneumonia in March 2020. In addition to lopinavir/ritonavir and hydroxychloroquine, he was treated with two doses of tocilizumab, displaying a significant clinical improvement. This is the first case described in the literature of an adult patient affected by cystic fibrosis who received tocilizumab for COVID-19, with documented total recovery, also assessed by a spirometry.


Asunto(s)
Anticuerpos Monoclonales Humanizados/administración & dosificación , Fibrosis Quística , Hidroxicloroquina/administración & dosificación , Lopinavir/administración & dosificación , Neumonía Viral , Infecciones del Sistema Respiratorio/microbiología , Ritonavir/administración & dosificación , /aislamiento & purificación , Adulto , Antivirales/administración & dosificación , /diagnóstico , /fisiopatología , Fibrosis Quística/complicaciones , Fibrosis Quística/inmunología , Fibrosis Quística/fisiopatología , Combinación de Medicamentos , Humanos , Pulmón/diagnóstico por imagen , Pulmón/fisiopatología , Masculino , Terapia por Inhalación de Oxígeno/métodos , Neumonía Viral/diagnóstico , Neumonía Viral/tratamiento farmacológico , Neumonía Viral/etiología , Receptores de Interleucina-6/antagonistas & inhibidores , Pruebas de Función Respiratoria/métodos , Infecciones del Sistema Respiratorio/tratamiento farmacológico , Infecciones del Sistema Respiratorio/etiología , Tomografía Computarizada por Rayos X/métodos , Resultado del Tratamiento
4.
Rev. ciênc. farm. básica apl ; 40: [3], 01/01/2019.
Artículo en Inglés | LILACS (Américas) | ID: covidwho-1016816

RESUMEN

The use of chloroquine and hydroxychloroquine as off-label treatments for covid-19 disease is a resort for critical care patients under enteral nutrition (EN). However, the use of solid pharmaceutical forms of these drugs through feeding tubes can pose a challenge to the health care team. Therefore, we performed a review of literature regarding administration of chloroquine and hydroxychloroquine through feeding tubes. For this end, a search was performed on PubMed and Lilacs database using key-words and free terms referring to drug administration via feeding tubes, and, specifically chloroquine and hydroxychloroquine. Also, a search on Micromedex® database and on the Handbook of Drug Administration via Enteral Feeding Tubes were performed. A total of 1.784 articles were retrieved. However, 4 articles fitted in the inclusion criteria. Two articles exploring the administration of chloroquine via feeding tubes on children with malaria found no difference on clinical results or tolerability when comparing it with oral or intramuscular administration. Other article showed full dispersion of hydroxychloroquine on water after crushing with mortar and pestle. A review found no information regarding the administration of hydroxychloroquine via postpyloric feeding tubes. No information was found on Micromedex® or the consulted Handbook; however, they pointed out the interaction between chloroquine and multivalent ions if coadministered.(AU)


Asunto(s)
Humanos , Cloroquina/administración & dosificación , Nutrición Enteral/instrumentación , Coronavirus , Hidroxicloroquina/administración & dosificación , Infecciones por Coronavirus/terapia
5.
Trials ; 22(1): 4, 2021 Jan 04.
Artículo en Inglés | MEDLINE | ID: covidwho-1007148

RESUMEN

OBJECTIVES: We will evaluate the efficacy and safety of Ivermectin in patients with mild and moderately severe COVID-19. TRIAL DESIGN: This is a phase 3, single-center, randomized, open-label, controlled trial with a 2-arm parallel-group design (1:1 ratio). PARTICIPANTS: The Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will screen for patients age ≥ 20 years and weight ≥35 kg for the following criteria: Inclusion criteria for patients with mild COVID-19 symptoms (outpatients) 1. Diagnosed mild pneumonia using computed tomography (CT) and/or chest X-ray (CX-R) imaging, not requiring hospitalization. 2. Signing informed consent. Inclusion criteria for patients with moderate COVID-19 symptoms (inpatients) 1. Confirmed infection using PCR. 2. Diagnosed moderate pneumonia using CT and/or CXR imaging, requiring hospitalization. 3. Hospitalized ≤ 48 hours. 4. Signing informed consent. Exclusion criteria 1. Severe and critical pneumonia due to COVID-19. 2. Underlying diseases, including AIDS, asthma, loiasis, and severe liver and kidney disease. 3. Use of anticoagulants (e.g., warfarin) and ACE inhibitors (e.g., captopril). 4. History of drug allergy to Ivermectin. 5. Pregnancy or breastfeeding. INTERVENTION AND COMPARATOR: Intervention groups: Outpatient and inpatient groups will receive the standard treatment regimen for mild and moderate COVID-19, based on the Iranian Ministry of Health and Medical Education's protocol, along with oral Ivermectin (MSD Company, France) at a single dose of 0.2 mg/kg. Control groups: The outpatient group will receive hydroxychloroquine sulfate (Amin Pharmaceutical Company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for seven subsequent days. The inpatient group will receive 200/50 mg Lopinavir/Ritonavir (Heterd Company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day. Other supportive and routine care will be the same in both outpatient and inpatient groups. MAIN OUTCOME: The primary outcomes are composite and include the improvement of clinical symptoms and need for hospitalization for outpatient groups, and the length of hospital stay until discharge, the need for ICU admission until discharge, and the need for mechanical ventilation for inpatient groups within seven days of randomization. The secondary outcome is the incidence of serious adverse drug reactions within seven days of randomization. RANDOMIZATION: Patients in both outpatient (mild) and inpatient (moderate) groups will be randomized into the treatment and control groups based on the following method. A simple randomization method and table of random numbers will be used. If the selected number is even, the patient is allocated to the treatment group, and if it is odd, the patient is allocated to the control group in a 1:1 ratio. BLINDING (MASKING): This is an open-label study, and there is not blinding. Numbers to be randomized (sample size) A total number of 120 patients (60 outpatients and 60 patients) will be randomized into two groups (30 patients in each of the intervention groups and 30 patients in each of the control groups). TRIAL STATUS: The protocol is Version 1.0, November 17, 2020. Recruitment began November 25, 2020, and is anticipated to be completed by February 25, 2021. TRIAL REGISTRATION: This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is " IRCT20200506047323N6 ". The registration date is November 17, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.


Asunto(s)
Antivirales/administración & dosificación , Ivermectina/administración & dosificación , /aislamiento & purificación , Administración Oral , Adulto , Antivirales/efectos adversos , /virología , Ensayos Clínicos Fase III como Asunto , Quimioterapia Combinada/efectos adversos , Quimioterapia Combinada/métodos , Femenino , Humanos , Hidroxicloroquina/administración & dosificación , Hidroxicloroquina/efectos adversos , Unidades de Cuidados Intensivos/estadística & datos numéricos , Interferón beta-1a/administración & dosificación , Interferón beta-1a/efectos adversos , Irán , Ivermectina/efectos adversos , Tiempo de Internación/estadística & datos numéricos , Lopinavir/administración & dosificación , Lopinavir/efectos adversos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Ritonavir/administración & dosificación , Ritonavir/efectos adversos , Índice de Severidad de la Enfermedad
6.
Swiss Med Wkly ; 150: w20446, 2020 12 14.
Artículo en Inglés | MEDLINE | ID: covidwho-1004915

RESUMEN

AIMS OF THE STUDY: Hydroxychloroquine and lopinavir/ritonavir have been used as experimental therapies to treat COVID-19 during the first wave of the pandemic. Randomised controlled trials have recently shown that there are no meaningful benefits of these two therapies in hospitalised patients. Uncertainty remains regarding the potential harmful impact of these therapies as very early treatments and their burden to the health care system. The present study investigated the length of hospital stay (LOS), mortality, and costs of hydroxychloroquine, lopinavir/ritonavir or their combination in comparison with standard of care among patients hospitalised for coronavirus disease 2019 (COVID-19). METHODS: This retrospective observational cohort study took place in the Geneva University Hospitals, Geneva, Switzerland (n = 840) between 26 February and 31 May 2020. Demographics, treatment regimens, comorbidities, the modified National Early Warning Score (mNEWS) on admission, and contraindications to COVID-19 treatment options were assessed. Outcomes included LOS, in-hospital mortality, and drug and LOS costs. RESULTS: After successful propensity score matching, patients treated with (1) hydroxychloroquine, (2) lopinavir/ritonavir or (3) their combination had on average 3.75 additional hospitalisation days (95% confidence interval [CI] 1.37–6.12, p = 0.002), 1.23 additional hospitalisation days (95% CI −1.24 – 3.51, p = 0.319), and 4.19 additional hospitalisation days (95% CI 1.52–5.31, p <0.001), respectively, compared with patients treated with the standard of care. Neither experimental therapy was significantly associated with mortality. These additional hospital days amounted to 1010.77 additional days for hydroxychloroquine and hydroxychloroquine combined with lopinavir/ritonavir, resulting in an additional cost of US$ 2,492,214 (95%CI US$ 916,839–3,450,619). CONCLUSIONS: Prescribing experimental therapies for COVID-19 was not associated with a reduced LOS and might have increased the pressure put on healthcare systems.


Asunto(s)
Antivirales/uso terapéutico , /epidemiología , Hidroxicloroquina/uso terapéutico , Lopinavir/uso terapéutico , Ritonavir/uso terapéutico , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Antivirales/administración & dosificación , Antivirales/efectos adversos , Niño , Preescolar , Comorbilidad , Combinación de Medicamentos , Quimioterapia Combinada , Gastos en Salud , Mortalidad Hospitalaria/tendencias , Humanos , Hidroxicloroquina/administración & dosificación , Hidroxicloroquina/efectos adversos , Lactante , Tiempo de Internación/estadística & datos numéricos , Lopinavir/administración & dosificación , Lopinavir/efectos adversos , Persona de Mediana Edad , Pandemias , Estudios Retrospectivos , Ritonavir/administración & dosificación , Ritonavir/efectos adversos , Índice de Severidad de la Enfermedad , Factores Sexuales , Factores Socioeconómicos , Terapias en Investigación/métodos , Adulto Joven
7.
Rheumatol Int ; 41(2): 257-273, 2021 02.
Artículo en Inglés | MEDLINE | ID: covidwho-1002076

RESUMEN

Sudden cardiac death is commonly seen due to arrhythmias, which is a common cardiac manifestation seen in COVID-19 patients, especially those with underlying cardiovascular disease (CVD). Administration of hydroxychloroquine (HCQ) as a potential treatment option during SARS-CoV-2, initially gained popularity, but later, its safe usage became questionable due to its cardiovascular safety, largely stemming from instances of cardiac arrhythmias in COVID-19. Moreover, in the setting of rheumatic diseases, in which patients are usually on HCQ for their primary disease, there is a need to scale the merits and demerits of HCQ usage for the treatment of COVID-19. In this narrative review, we aim to address the association between usage of HCQ and sudden cardiac death in COVID-19 patients. MEDLINE, EMBASE, ClinicalTrials.gov and SCOPUS databases were used to review articles in English ranging from case reports, case series, letter to editors, systematic reviews, narrative reviews, observational studies and randomized control trials. HCQ is a potential cause of sudden cardiac death in COVID-19 patients. As opposed to the reduction in CVD with HCQ in treatment of systemic lupus erythematous, rheumatoid arthritis, and other rheumatic diseases, safe usage of HCQ in COVID-19 patients is unclear; whereby, it is observed to result in QTc prolongation and Torsades de pointes even in patients with no underlying cardiovascular comorbidity. This is occasionally associated with sudden cardiac death or cardiac arrest; hence, its clinical efficacy needs further investigation by large-scale clinical trials.


Asunto(s)
Antirreumáticos/efectos adversos , Muerte Súbita Cardíaca/etiología , Hidroxicloroquina/efectos adversos , Antirreumáticos/administración & dosificación , Humanos , Hidroxicloroquina/administración & dosificación , Pandemias , Enfermedades Reumáticas/tratamiento farmacológico , Medición de Riesgo
8.
J Infect Dev Ctries ; 14(12): 1368-1373, 2020 12 31.
Artículo en Inglés | MEDLINE | ID: covidwho-1000365

RESUMEN

INTRODUCTION: Current pandemic of the coronavirus induced disease 2019 (COVID-19) presents an urgent issue to the world due to lack of vaccine and medication. Hydroxychloroquine (HCQ) has generated a lot of controversies whether it is effective in prevention and treatment of COVID-19. Current report presents a 63-year-old woman who has taken HCQ for many years but still infected by COVID-19. CASE PRESENTATION: A patient with rheumatoid arthritis came to the clinic with fever and sore throat. The patient has been treated with 200 mg HCQ per day since 2016. Laboratory tests showed that the patient had lymphopenia, increased levels of high-sensitive C-reactive protein (hs-CRP) and serum Interleukin-6 (IL-6). Chest radiography showed that the patient had pneumonia. Throat swab test confirmed COVID-19 positive. On admission, she was treated with nebulized interferon alfa-2b, oral Lopinavir/Ritonavir, and ceftriaxone sodium for the COVID-19 in addition to HCQ. The patient stayed in hospital for 18 days, recovered from oxygen intake, and eventually discharged from hospital. Follow up investigation showed the patient developed antibody against COVID-19. CONCLUSIONS: Long-term application of HCQ could not prevent COVID-19 infection, but whether HCQ exerts benefit to alleviation of clinical symptoms and duration of hospital stays remains to be further investigated.


Asunto(s)
Antivirales/administración & dosificación , /prevención & control , Hidroxicloroquina/administración & dosificación , Antivirales/uso terapéutico , Femenino , Humanos , Interferón alfa-2/uso terapéutico , Persona de Mediana Edad , Radiografía , Factores de Tiempo , Resultado del Tratamiento
9.
PLoS One ; 15(12): e0244272, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-999839

RESUMEN

OBJECTIVES: To describe the clinical characteristics of patients infected with SARS-CoV-2 at Clinique Ngaliema, a public hospital, in Kinshasa, in the Democratic Republic of Congo (DRC). METHODS: This retrospective study analyzed medical records including socio-demographics, past medical history, clinical manifestation, comorbidities, laboratory data, treatment and disease outcome of 160 hospitalized COVID-19 patients, with confirmed result of SARS-CoV-2 viral infection. RESULTS: The median age of patients was 54 years (IQR: 38-64), and there was no significant gender difference (51% of male). The most common comorbidities were hypertension (55 [34%]), diabetes (31 [19%]) and obesity (13 [8%]). Fever (93 [58%]), cough (92 [57%]), fatigue (87 [54%]), shortness of breath (72 [45%]) and myalgia (33 [21%]) were the most common symptoms, upon admission. Patients were categorized into mild (92 [57%]), moderate (19 [12%]) and severe (49 [31%]). Severe patients were older and were more likely to have comorbidities, compared to mild ones. The majority of patients (92% [147 of 160]) patients received hydroxychloroquine or chloroquine phosphate. Regression model revealed that older age, lower SpO2, higher heart rate and elevated AST at admission were all risk factors associated with in-hospital death. The prevalence of COVID-19 and malaria co-infection was 0.63% and 70 (44%) of all patients received antimalarial treatment before hospitalization. CONCLUSION: Our findings indicated that the epidemiological and clinical feature of COVID-19 patients in Kinshasa are broadly similar to previous reports from other settings. Older age, lower SpO2, tachycardia, and elevated AST could help to identify patients at higher risk of death at an early stage of the illness. Plasmodium spp co-infection was not common in hospitalized COVID-19 patients.


Asunto(s)
/diagnóstico , /epidemiología , Adulto , Anciano , Coagulación Sanguínea , Cloroquina/administración & dosificación , Cloroquina/análogos & derivados , Coinfección , Comorbilidad , Tos , República Democrática del Congo/epidemiología , Femenino , Fiebre , Hospitalización , Hospitales Públicos , Humanos , Hidroxicloroquina/administración & dosificación , Inflamación , Pruebas de Función Hepática , Malaria/complicaciones , Masculino , Persona de Mediana Edad , Análisis de Regresión , Estudios Retrospectivos , Factores de Riesgo , Clase Social , Taquicardia/complicaciones
10.
Intern Med J ; 50(12): 1559-1562, 2020 12.
Artículo en Inglés | MEDLINE | ID: covidwho-991429

RESUMEN

Hydroxychloroquine is being used for COVID-19 symptoms and in clinical trials, but can cause a toxic myopathy that leads to muscle weakness. A review of skeletal muscle biopsies from patients with hydroxychloroquine myopathy gives pointers of steps that can be taken to diagnose this toxic myopathy early and help differentiate it from COVID-19-related muscle weakness.


Asunto(s)
/diagnóstico , Hidroxicloroquina/efectos adversos , Debilidad Muscular/inducido químicamente , Debilidad Muscular/diagnóstico , Enfermedades Musculares/inducido químicamente , Enfermedades Musculares/diagnóstico , Adulto , Anciano , Anciano de 80 o más Años , Antirreumáticos/administración & dosificación , Antirreumáticos/efectos adversos , Diagnóstico Diferencial , Humanos , Hidroxicloroquina/administración & dosificación , Persona de Mediana Edad , Pandemias
11.
J Antimicrob Chemother ; 76(3): 753-757, 2021 02 11.
Artículo en Inglés | MEDLINE | ID: covidwho-990733

RESUMEN

INTRODUCTION: Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection. METHODS: This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1. RESULTS: Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P < 0.001. CONCLUSIONS: In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.


Asunto(s)
Atención Ambulatoria/métodos , Antivirales/administración & dosificación , /tratamiento farmacológico , Carbamatos/administración & dosificación , Imidazoles/administración & dosificación , Pirrolidinas/administración & dosificación , Sofosbuvir/administración & dosificación , Valina/análogos & derivados , Adulto , Atención Ambulatoria/tendencias , Antimaláricos/administración & dosificación , Método Doble Ciego , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Hidroxicloroquina/administración & dosificación , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Valina/administración & dosificación
12.
Circ Arrhythm Electrophysiol ; 13(10): e008686, 2020 10.
Artículo en Inglés | MEDLINE | ID: covidwho-982511

RESUMEN

BACKGROUND: Based on inhibition of viral replication and limited reports on clinical efficacy, hydroxychloroquine is being considered as prophylaxis and treatment of coronavirus disease-19 (COVID-19). Although hydroxychloroquine is generally considered safe during pregnancy based on studies in patients with systemic lupus erythematosus and other rheumatic conditions, there may still be reluctance to institute this antimalarial during pregnancy for the sole purpose of antiviral therapy. METHODS: To provide data regarding any potential fetal/neonatal cardiotoxicity, we leveraged a unique opportunity in which neonatal ECGs and hydroxychloroquine blood levels were available in a recently completed study evaluating the efficacy of hydroxychloroquine 400 mg daily to prevent the recurrence of congenital heart block associated with anti-SSA/Ro (anti-Sjögren's Syndrome A/Ro) antibodies. RESULTS: Forty-five ECGs were available for corrected QT interval (QTc) measurement, and levels of hydroxychloroquine were assessed during each trimester of pregnancy and in the cord blood, providing unambiguous assurance of drug exposure. Overall, there was no correlation between cord blood levels of hydroxychloroquine and the neonatal QTc (R=0.02, P=0.86) or the mean of hydroxychloroquine values obtained throughout each individual pregnancy and the QTc (R=0.04, P=0.80). In total 5 (11% [95% CI, 4%-24%]) neonates had prolongation of the QTc >2 SD above historical healthy controls (2 markedly and 3 marginally) but ECGs were otherwise normal. CONCLUSIONS: In aggregate, these data provide reassurances that the maternal use of hydroxychloroquine is associated with a low incidence of infant QTc prolongation. However, if included in clinical COVID-19 studies, early postnatal ECGs should be considered. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01379573.


Asunto(s)
Antivirales/administración & dosificación , Electrocardiografía , Corazón Fetal/efectos de los fármacos , Bloqueo Cardíaco/congénito , Frecuencia Cardíaca/efectos de los fármacos , Hidroxicloroquina/administración & dosificación , Antivirales/efectos adversos , Antivirales/sangre , Cardiotoxicidad , Esquema de Medicación , Monitoreo de Drogas , Femenino , Sangre Fetal/metabolismo , Corazón Fetal/fisiopatología , Edad Gestacional , Bloqueo Cardíaco/diagnóstico , Bloqueo Cardíaco/fisiopatología , Bloqueo Cardíaco/prevención & control , Humanos , Hidroxicloroquina/efectos adversos , Hidroxicloroquina/sangre , Lactante , Recién Nacido , Masculino , Valor Predictivo de las Pruebas , Embarazo , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
14.
Biosci Trends ; 14(6): 408-414, 2021 Jan 23.
Artículo en Inglés | MEDLINE | ID: covidwho-979798

RESUMEN

The aim of this study is to assess the efficacy of multiple treatments, especially hydroxychloroquine, used in different disease stages of coronavirus disease 2019 (COVID-19). All consecutive patients with COVID-19 admitted to Shanghai Public Health Clinical Center (Shanghai, China) between January 20, 2020, and April 30, 2020, were enrolled, and their clinical data were retrospectively collected. Binary logistic regression was used to screen the factors associated with disease aggravation, and multivariable analyses with the Cox proportional hazards model were used to estimate the effects of prognostic factors on the improvement time and PCR conversion days in throat swabs and stool swabs. A total of 616 patients, including 50 (8.11%) severe and 18 (2.92%) critical patients, were enrolled in our retrospective cohort study. The early use of hydroxychloroquine was a protective factor associated with disease aggravation (95% CI: 0.040-0.575, p = 0.006). Clinical improvement by 20 days was significantly different between patients with hydroxychloroquine used early and those with hydroxychloroquine not used (p = 0.016, 95% CI: 1.052-1.647). The median time to clinical improvement was 6 days in the hydroxychloroquine used early group, compared with 9 days in the without hydroxychloroquine used group and 8 days in the with hydroxychloroquine not used early group (p < 0.001). Hydroxychloroquine used early was associated with earlier PCR conversion in both throat swabs (HR = 1.558, p = 0.001) and stool swabs (HR = 1.400, p = 0.028). The use of hydroxychloroquine at an early stage is a potential therapeutic strategy for treating patients before irreversible severe respiratory complications occur. The early use of hydroxychloroquine decreased the improvement time and the duration of COVID-19 detection in throat and stool swabs.


Asunto(s)
Antimaláricos/administración & dosificación , Hidroxicloroquina/administración & dosificación , Adulto , Anciano , China , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento
15.
J Med Case Rep ; 14(1): 210, 2020 Nov 03.
Artículo en Inglés | MEDLINE | ID: covidwho-901919

RESUMEN

BACKGROUND: Since the World Health Organization declared a global pandemic due to the novel coronavirus disease2019, there have been targeted efforts to establish management modalities. Hydroxychloroquine has been suggested as a possible treatment; however, it is associated with multiple adverse reactions. We report a rare case of a patient with acute generalized exanthematous pustulosis with Stevens-Johnson syndrome due to hydroxychloroquine. Acute generalized exanthematous pustulosis is characterized by acute onset of a generalized rash that is pustular and erosive in nature, affecting limbs; trunk; face; and, less often, mucosal membranes. Although rare, it is important to be mindful of this side effect because the diagnosis is often delayed, and the disease has the potential to be life-threatening. CASE PRESENTATION: A 68-year-old American woman presented to our hospital with a painful, rapidly spreading rash. Its morphologic features included erythema multiforme-like lesions with extensive skin sloughing in various regions of the head, neck, and trunk and mucosal involvement. Her Nikolsky sign was negative, and she had no evidence of lesions on areas of skin trauma. Four weeks prior, she had been initiated on hydroxychloroquine for a presumed diagnosis of cutaneous sarcoidosis. Three punch biopsies of the head and neck area revealed subcorneal pustules consistent with acute generalized exanthematous pustulosis. Treatment began with high doses of methylprednisolone, leading to only minimal improvement of existing areas and ongoing spread to new areas. Treatment with intravenous immunoglobulin was initiated, at which point disease stability was achieved. The patient's rash ultimately resolved, as did her cutaneous pain and pruritus. CONCLUSIONS: Among many potential adverse reactions involving hydroxychloroquine, cutaneous side effects are varied and can lead to significant morbidity or even death. The drug is currently being investigated in a multitude of trials for coronavirus disease2019 treatment, prevention, and prophylaxis after exposure to severe acute respiratory syndrome coronavirus 2. Acute generalized exanthematous pustulosis is a rare side effect of hydroxychloroquine, and even fewer cases demonstrate histologic evidence of acute generalized exanthematous pustulosis while clinically presenting with Stevens-Johnson syndrome. Patients who develop Stevens-Johnson syndrome/toxic epidermal necrolysis require best supportive care with aggressive fluid and electrolyte replacement and prevention of further breakdown of the skin barrier. With the potential of widespread hydroxychloroquine use, it is important that providers be aware of its potential severe adverse drug reactions.


Asunto(s)
Pustulosis Exantematosa Generalizada Aguda , Infecciones por Coronavirus/epidemiología , Hidroxicloroquina , Inmunoglobulinas Intravenosas/administración & dosificación , Metilprednisolona/administración & dosificación , Neumonía Viral/epidemiología , Sarcoidosis/tratamiento farmacológico , Síndrome de Stevens-Johnson , Pustulosis Exantematosa Generalizada Aguda/diagnóstico , Pustulosis Exantematosa Generalizada Aguda/etiología , Pustulosis Exantematosa Generalizada Aguda/fisiopatología , Pustulosis Exantematosa Generalizada Aguda/terapia , Anciano , Antimaláricos/administración & dosificación , Antimaláricos/efectos adversos , Biopsia/métodos , Femenino , Humanos , Hidroxicloroquina/administración & dosificación , Hidroxicloroquina/efectos adversos , Factores Inmunológicos , Pandemias , Piel/patología , Enfermedades de la Piel/tratamiento farmacológico , Síndrome de Stevens-Johnson/diagnóstico , Síndrome de Stevens-Johnson/etiología , Síndrome de Stevens-Johnson/fisiopatología , Síndrome de Stevens-Johnson/terapia , Resultado del Tratamiento
16.
Klin Onkol ; 33(5): 386-389, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-895742

RESUMEN

BACKGROUND: In December 2019 a new strain of coronavirus SARS-CoV-2 has emerged and affected health care worldwide. Patients with cancer and other comorbidities are at increased risk for adverse outcomes in this infection. CASE: In this case report we present a 75-year-old patient with a localized gastric adenocarcinoma, currently treated by perioperative chemotherapy regimen, who had an rT-PCR proven novel coronavirus SARS-CoV-2 infection. Laboratory and radiologic assessments were performed in order to assess disease severity; however, the findings were not altered in accordance with the findings associated with COVID-19 disease. RESULTS: On the first hospital day the patient had a low grade fever with chills. Subsequently a pharmacological therapy with hydroxychloroquine and azithromycin was started. After pharmacologic and symptomatic treatment, the patient was reassessed for SARS-CoV-2, with negative results. At discharge, the patient was ordered a 14-day mandatory quarantine. After 57 days of follow-up, the patient underwent a new rapid antibody test by Acro Biotech inc., which gave negative results for IgM and IgG. CONCLUSION: An infection with SARS-CoV-2 is associated with a more severe disease in patients with comorbidities and cancer; however, this case patient had a mild course of COVID-19 disease. The aim of this case report is to share the information on the clinical course and outcomes of a patient with malignancy. Rapid spreading of information is crucial in the management of COVID-19.


Asunto(s)
Adenocarcinoma/complicaciones , Infecciones por Coronavirus/complicaciones , Neumonía Viral/complicaciones , Neoplasias Gástricas/complicaciones , Anciano , Azitromicina/administración & dosificación , Betacoronavirus , Infecciones por Coronavirus/tratamiento farmacológico , Humanos , Hidroxicloroquina/administración & dosificación , Masculino , Pandemias , Alta del Paciente , Neumonía Viral/tratamiento farmacológico , Eslovaquia , Resultado del Tratamiento
17.
Trials ; 21(1): 866, 2020 Oct 20.
Artículo en Inglés | MEDLINE | ID: covidwho-883593

RESUMEN

OBJECTIVES: 1. To compare the safety and efficacy of Hydroxychloroquine with Ribavirin and standard treatment in patients with non-severe COVID-19 infection 2. To compare the safety and efficacy of standard treatment, Lopinavir-ritonavir with Ribavarin, and Hydroxychloroquine with Ribavirin in patients with severe COVID-19 infection TRIAL DESIGN: The study is an Open label, Parallel arm design, stratified randomised controlled trial. Patients will be categorised as non-severe or severe based on predefined criteria. Those who satisfy all inclusion criteria and no exclusion criteria in the respective categories, will be randomly assigned to one of the three treatment groups in a ratio of 1:1 in the non-severe category and 1:1:1 in the severe category. PARTICIPANTS: The trial will be undertaken in a tertiary care center of the country where both Covid and non-Covid patients are getting treated. All patients who are confirmed positive and admitted will be screened for the eligibility criteria and will be enrolled in the study after a written informed consent. Patients will be categorised as non-severe or severe based on predefined criteria. INCLUSION CRITERIA (ALL REQUIRED): 1. Age ≥18 years at time of participation in the study 2. Laboratory (RT-PCR) confirmed infection with SARS-CoV-2 3. Symptomatic (severe or non-severe) Covid-19 disease 4. Willingness of study participant to accept randomization to any assigned treatment arm EXCLUSION CRITERIA: 1. Use of medications that are contraindicated with Lopinavir/Ritonavir, Hydroxychloroquine/Chloroquine, or Ribavirin and that cannot be replaced or stopped 2. Patient already on antiretroviral therapy with Lopinavir-Ritonavir based regimen or on Hydroxychloroquine/Chloroquine or on Ribavirin 3. Any known contraindication to test drugs such as retinopathy and QT prolongation 4. Known allergic reaction or inability to take orally of Lopinavir-ritonavir, Hydroxychloroquine/ Chloroquine, Ribavarin 5. Pregnant or breastfeeding females 6. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within 30 days prior to participation in the present study or want to participate after enrolment INTERVENTION AND COMPARATOR: Two therapeutic interventions for non-severe category and three for severe category as described below NON-SEVERE TREATMENT ARMS (NS-GROUP): Treatment Arm Drug A Standard Treatment (STNS) B Hydroxychloroquine 400 mg twice on first day followed by 400 mg per oral daily for 10 days + Ribavirin (1.2 g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (STNS) Standard Treatment for non-severe cases (STNS): Strict Isolation, Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask), Hydration, Proper Nutrition, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Treatment of Comorbid Diseases, Oseltamivir (75 mg BD) for patients who are tested positive for H1N1. SEVERE GROUP TREATMENT ARMS (S-GROUP): Treatment Arm Drug A Standard Treatment (STs) B Hydroxychloroquine 400mg BD on day1 followed by 400 mg once daily + Ribavirin (1.2 g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (STs) C Lopinavir(200mg) + Ritonavir (50mg) two tablets twice daily+ Ribavirin (1.2g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (STs)6 Standard Treatment for severe patients (STs): Strict Isolation, Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask), Fluid Therapy, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Oxygen supplementation (As required), Invasive ventilation (As required), Antibiotic agents for other associated infections (according to 2019 ATS/IDSA guidelines for non-ICU and ICU patients), Vasopressor support, Renal-replacement therapy, Treatment of Comorbid Diseases, Oseltamivir (75 mg BD) for patients who are tested positive for H1N1. MAIN OUTCOMES: Primary endpoints: (1) Time to Clinical recovery (TTCR) defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, oxygen saturation, and alleviation of cough, sustained for at least 72 hours. (2) Time to SARS-CoV-2 RT-PCR negative in upper respiratory tract specimen, time to laboratory recovery of each organ involvement. Secondary Endpoints: All causes mortality, Frequency of respiratory progression (defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support), time to defervescence (in those with fever at enrolment), frequency of requirement for supplemental oxygen or non-invasive ventilation, frequency of requirement for mechanical ventilation, frequency of serious adverse events as per DAIDS table grade of severity. Outcomes are monitored for 28 days from the time of enrolment into the study OR until the patient is discharged or death whichever is longer. RANDOMIZATION: The randomization will be done using a secured central computer-based randomization using a secure website using a central, computer-based randomisation program in a ratio of 1:1 in the non-severe category and 1:1:1 in the severe category. BLINDING (MASKING): This is an open labelled study i.e. Study assigned treatment will be known to the research team, the investigators and participants. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Since it is an exploratory trial as COVID-19 being a new disease, all patients who came under the purview of the inclusion criteria within the study period (5 months duration of the recruitment period of the total 6 months duration of the study i.e. from the month of June, 2020 to October 2020) and who have consented for the study will be included. TRIAL STATUS: Protocol version:1.0 Recruitment start: June 3rd, 2020 (Ongoing) Recruitment finish (expected): October 31st, 2020 TRIAL REGISTRATION: Clinical Trial Registry of India (CTRI): CTRI/2020/06/025575 . Registration on 03 June 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.


Asunto(s)
Antivirales/uso terapéutico , Betacoronavirus/efectos de los fármacos , Infecciones por Coronavirus/tratamiento farmacológico , Neumonía Viral/tratamiento farmacológico , Ribavirina/uso terapéutico , Administración Oral , Adulto , Antimaláricos/administración & dosificación , Antimaláricos/uso terapéutico , Antivirales/administración & dosificación , Betacoronavirus/genética , Protocolos Clínicos , Terapia Combinada , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/virología , Inhibidores del Citocromo P-450 CYP3A/administración & dosificación , Inhibidores del Citocromo P-450 CYP3A/uso terapéutico , Femenino , Humanos , Hidroxicloroquina/administración & dosificación , Hidroxicloroquina/uso terapéutico , India/epidemiología , Consentimiento Informado , Lopinavir/administración & dosificación , Lopinavir/uso terapéutico , Masculino , Pandemias , Neumonía Viral/epidemiología , Neumonía Viral/virología , Ribavirina/administración & dosificación , Ritonavir/administración & dosificación , Ritonavir/uso terapéutico , Seguridad , Factores de Tiempo , Resultado del Tratamiento
18.
PLoS One ; 15(10): e0239389, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-874169

RESUMEN

INTRODUCTION: The COVID-19 pandemic has posed major challenges to all aspects of healthcare. Malta's population density, large proportion of elderly and high prevalence of diabetes and obesity put the country at risk of uncontrolled viral transmission and high mortality. Despite this, Malta achieved low mortality rates compared to figures overseas. The aim of this paper is to identify key factors that contributed to these favorable outcomes. METHODS: This is a retrospective, observational, nationwide study which evaluates outcomes of patients during the first wave of the pandemic in Malta, from the 7th of March to the 24th of April 2020. Data was collected on demographics and mode of transmission. Hospitalization rates to Malta's main general hospital, Mater Dei Hospital, length of in-hospital stay, intensive care unit admissions and 30-day mortality were also analyzed. RESULTS: There were 447 confirmed cases in total; 19.5% imported, 74.2% related to community transmission and 6.3% nosocomially transmitted. Ninety-three patients (20.8%) were hospitalized, of which 4 were children. Patients with moderate-severe disease received hydroxychloroquine and azithromycin, in line with evidence available at the time. A total of 4 deaths were recorded, resulting in an all-cause mortality of 0.89%. Importantly, all admitted patients with moderate-severe disease survived to 30-day follow up. CONCLUSION: Effective public health interventions, widespread testing, remote surveillance of patients in the community and a low threshold for admission are likely to have contributed to these favorable outcomes. Hospital infection control measures were key in preventing significant nosocomial spread. These concepts can potentially be applied to stem future outbreaks of viral diseases. Patients with moderate-severe disease had excellent outcomes with no deaths reported at 30-day follow up.


Asunto(s)
Infecciones por Coronavirus/epidemiología , Neumonía Viral/epidemiología , Adulto , Anciano , Antivirales/administración & dosificación , Antivirales/uso terapéutico , Azitromicina/administración & dosificación , Azitromicina/uso terapéutico , Infecciones por Coronavirus/mortalidad , Infecciones por Coronavirus/terapia , Utilización de Medicamentos/estadística & datos numéricos , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Hidroxicloroquina/administración & dosificación , Hidroxicloroquina/uso terapéutico , Unidades de Cuidados Intensivos/estadística & datos numéricos , Tiempo de Internación/estadística & datos numéricos , Masculino , Malta , Persona de Mediana Edad , Pandemias , Neumonía Viral/mortalidad , Neumonía Viral/terapia , Análisis de Supervivencia
19.
J Cardiovasc Med (Hagerstown) ; 21(11): 922-923, 2020 11.
Artículo en Inglés | MEDLINE | ID: covidwho-868851
20.
Front Immunol ; 11: 560381, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-853933

RESUMEN

Background: Emerging evidence indicates a potential role for monocytes in COVID-19 immunopathology. We investigated two soluble markers of monocyte activation, sCD14 and sCD163, in COVID-19 patients, with the aim of characterizing their potential role in monocyte-macrophage disease immunopathology. To the best of our knowledge, this is the first study of its kind. Methods: Fifty-nine SARS-Cov-2 positive hospitalized patients, classified according to ICU or non-ICU admission requirement, were prospectively recruited and analyzed by ELISA for levels of sCD14 and sCD163, along with other laboratory parameters, and compared to a healthy control group. Results: sCD14 and sCD163 levels were significantly higher among COVID-19 patients, independently of ICU admission requirement, compared to the control group. We found a significant correlation between sCD14 levels and other inflammatory markers, particularly Interleukin-6, in the non-ICU patients group. sCD163 showed a moderate positive correlation with the time lapsed from admission to sampling, independently of severity group. Treatment with corticoids showed an interference with sCD14 levels, whereas hydroxychloroquine and tocilizumab did not. Conclusions: Monocyte-macrophage activation markers are increased and correlate with other inflammatory markers in SARS-Cov-2 infection, in association to hospital admission. These data suggest a preponderant role for monocyte-macrophage activation in the development of immunopathology of COVID-19 patients.


Asunto(s)
Antígenos CD , Antígenos de Diferenciación Mielomonocítica , Betacoronavirus , Infecciones por Coronavirus , Receptores de Lipopolisacáridos , Pandemias , Neumonía Viral , Receptores de Superficie Celular , Corticoesteroides/administración & dosificación , Adulto , Anciano , Anticuerpos Monoclonales Humanizados/administración & dosificación , Antígenos CD/sangre , Antígenos CD/inmunología , Antígenos de Diferenciación Mielomonocítica/sangre , Antígenos de Diferenciación Mielomonocítica/inmunología , Betacoronavirus/inmunología , Betacoronavirus/metabolismo , Infecciones por Coronavirus/sangre , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/patología , Femenino , Humanos , Hidroxicloroquina/administración & dosificación , Unidades de Cuidados Intensivos , Interleucina-6/sangre , Interleucina-6/inmunología , Receptores de Lipopolisacáridos/sangre , Receptores de Lipopolisacáridos/inmunología , Activación de Macrófagos , Macrófagos/inmunología , Macrófagos/metabolismo , Macrófagos/patología , Masculino , Persona de Mediana Edad , Monocitos/inmunología , Monocitos/patología , Admisión del Paciente , Neumonía Viral/sangre , Neumonía Viral/tratamiento farmacológico , Neumonía Viral/inmunología , Neumonía Viral/patología , Receptores de Superficie Celular/sangre , Receptores de Superficie Celular/inmunología , Factores de Tiempo
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