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1.
Trials ; 22(1): 126, 2021 Feb 09.
Artículo en Inglés | MEDLINE | ID: covidwho-1076154

RESUMEN

BACKGROUND: The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 disease. Azithromycin is a macrolide antibiotic, known for its immunomodulatory properties. It has shown antiviral effect specifically against SARS-CoV-2 in vitro and acts on cytokine signaling pathways that have been implicated in COVID-19. METHODS: DAWn-AZITHRO is a randomized, open-label, phase 2 proof-of-concept, multicenter clinical trial, evaluating the safety and efficacy of azithromycin for treating hospitalized patients with COVID-19. It is part of a series of trials testing promising interventions for COVID-19, running in parallel and grouped under the name DAWn-studies. Patients hospitalized on dedicated COVID wards are eligible for study inclusion when they are symptomatic (i.e., clinical or radiological signs) and have been diagnosed with COVID-19 within the last 72 h through PCR (nasopharyngeal swab or bronchoalveolar lavage) or chest CT scan showing typical features of COVID-19 and without alternate diagnosis. Patients are block-randomized (9 patients) with a 2:1 allocation to receive azithromycin plus standard of care versus standard of care alone. Standard of care is mostly supportive, but may comprise hydroxychloroquine, up to the treating physician's discretion and depending on local policy and national health regulations. The treatment group receives azithromycin qd 500 mg during the first 5 consecutive days after inclusion. The trial will include 284 patients and recruits from 15 centers across Belgium. The primary outcome is time from admission (day 0) to life discharge or to sustained clinical improvement, defined as an improvement of two points on the WHO 7-category ordinal scale sustained for at least 3 days. DISCUSSION: The trial investigates the urgent and still unmet global need for drugs that may impact the disease course of COVID-19. It will either provide support or else justify the discouragement of the current widespread, uncontrolled use of azithromycin in patients with COVID-19. The analogous design of other parallel trials of the DAWN consortium will amplify the chance of identifying successful treatment strategies and allow comparison of treatment effects within an identical clinical context. TRIAL REGISTRATION: EU Clinical trials register EudraCT Nb 2020-001614-38 . Registered on 22 April 2020.


Asunto(s)
Antivirales/efectos adversos , Azitromicina/efectos adversos , /genética , Nivel de Atención , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antivirales/administración & dosificación , Azitromicina/administración & dosificación , Bélgica/epidemiología , /virología , Femenino , Humanos , Hidroxicloroquina/uso terapéutico , Tiempo de Internación , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Reacción en Cadena de la Polimerasa , Prueba de Estudio Conceptual , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Adulto Joven
2.
Pan Afr Med J ; 37(Suppl 1): 42, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-1069975

RESUMEN

The aim of this study was to evaluate the main clinical and evolutionary features of SARS-CoV-2 infection in children aged 0-18 years who were suspected and diagnosed for COVID-19 during routine consultations in the pediatric ward of the Ignace Deen National Hospital in Conakry. This retrospective study targeted all children admitted to the Pediatrics Department during the study period and focused on children whose clinical examination and/or history indicated a suspicion of SARS-CoV-2 infection. Only children with a positive reverse transcriptase-polymerase chain reaction (RT-PCR) test were included. Clinical and paraclinical data were rigorously analyzed. Anonymity and respect for ethical rules were the norm. Medical records were used as the data source and a questionnaire was developed for collection. The analysis was done using STATA/SE version 11.2 software. The mean age of the patients observed was 9.66±1.32 years, with a sex ratio of 1.25. The history of the patients found that 36.11 had already been in contact with a COVID-19 positive subject, of which 8 or 22 had close relatives treated for COVID-19 and 5 had been with classmates treated for COVID-19. Fever and physical asthenia, runny nose and throat pain were respectively found in 58.33%, 50% and 30.55% of patients with irritability in 25%. Asymptomatic children were 30.55%. The diagnosis was confirmed after a positive RT-PCR test. Thoracic computed tomography (CT) scan was normal in 80.55% of the children. They were given mostly azithromycin 15mg/kg, zinc and chloroquine sulfate 5mg/kg. The mean age of the patients observed was 9.66 years, with a sex ratio of 1.25. The history of the patients found that 36.11 had already been in contact with a COVID-19 positive subject, of which 8 or 22 had close relatives treated for COVID-19 and 5 had been with classmates treated for COVID-19. Fever and physical asthenia, runny nose and throat pain were respectively found in 58.33%, 50% and 30.55% of patients with irritability in 25%. Asymptomatic children were 30.55%. The diagnosis was confirmed after a positive RT-PCR test. Thoracic computed tomography (CT) scan was normal in 80.55% of the children. They were given mostly azithromycin 15mg/kg, zinc and chloroquine sulfate 5mg/kg.


Asunto(s)
Infecciones Asintomáticas/epidemiología , Hospitalización , Adolescente , Azitromicina/administración & dosificación , /fisiopatología , Niño , Preescolar , Cloroquina/administración & dosificación , Femenino , Guinea , Humanos , Lactante , Masculino , Estudios Retrospectivos , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa , Tomografía Computarizada por Rayos X , Zinc/administración & dosificación
3.
Life Sci ; 269: 119099, 2021 Mar 15.
Artículo en Inglés | MEDLINE | ID: covidwho-1036398

RESUMEN

AIMS: Azithromycin is widely used broad spectrum antibiotic recently used in treatment protocol of COVID-19 for its antiviral and immunomodulatory effects combined with Hydroxychloroquine or alone. Rat models showed that Azithromycin produces oxidative stress, inflammation, and apoptosis of myocardial tissue. Rosuvastatin, a synthetic statin, can attenuate myocardial ischemia with antioxidant and antiapoptotic effects. This study aims to evaluate the probable protective effect of Rosuvastatin against Azithromycin induced cardiotoxicity. MAIN METHOD: Twenty adult male albino rats were divided randomly into four groups, five rats each control, Azithromycin, Rosuvastatin, and Azithromycin +Rosuvastatin groups. Azithromycin 30 mg/kg/day and Rosuvastatin 2 mg/kg/day were administrated for two weeks by an intragastric tube. Twenty-four hours after the last dose, rats were anesthetized and the following measures were carried out; Electrocardiogram, Blood samples for Biochemical analysis of lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). The animals sacrificed, hearts excised, apical part processed for H&E, immunohistochemical staining, and examined by light microscope. The remaining parts of the heart were collected for assessment of Malondialdehyde (MDA) and Reduced Glutathione (GSH). KEY FINDINGS: The results revealed that Rosuvastatin significantly ameliorates ECG changes, biochemical, and Oxidative stress markers alterations of Azithromycin. Histological evaluation from Azithromycin group showed marked areas of degeneration, myofibers disorganization, inflammatory infiltrate, and hemorrhage. Immunohistochemical evaluation showed significant increase in both Caspase 3 and Tumor necrosis factor (TNF) immune stain. Rosuvastatin treated group showed restoration of the cardiac muscle fibers in H&E and Immunohistochemical results. SIGNIFICANCE: We concluded that Rosuvastatin significantly ameliorates the toxic changes of Azithromycin on the heart.


Asunto(s)
Antibacterianos/efectos adversos , Azitromicina/efectos adversos , Cardiotoxicidad/prevención & control , Rosuvastatina Cálcica/farmacología , Animales , Antibacterianos/administración & dosificación , Antioxidantes/administración & dosificación , Antioxidantes/farmacología , Apoptosis/efectos de los fármacos , Azitromicina/administración & dosificación , Cardiotoxicidad/etiología , Modelos Animales de Enfermedad , Glutatión/metabolismo , Inhibidores de Hidroximetilglutaril-CoA Reductasas/farmacología , Inflamación/inducido químicamente , Inflamación/prevención & control , Masculino , Malondialdehído/metabolismo , Estrés Oxidativo/efectos de los fármacos , Ratas , Ratas Sprague-Dawley , Rosuvastatina Cálcica/administración & dosificación
4.
BMJ Case Rep ; 13(12)2020 Dec 18.
Artículo en Inglés | MEDLINE | ID: covidwho-991779

RESUMEN

The SARS-CoV-2 has wreaked havoc globally and has claimed innumerable lives all over the world. The symptoms of this disease may range from mild influenza-like symptoms to severe acute respiratory distress syndrome with high morbidity and mortality. With improved diagnostic techniques and better disease understanding, an increased number of cases are being reported with extrapulmonary manifestations of this disease ranging from renal and gastrointestinal to cardiac, hepatic, neurological and haematological dysfunction. Subacute thyroiditis is a self-limiting and painful thyroid gland inflammation most often secondary to viral infections. We report a case of subacute thyroiditis in a 58-year-old gentleman presenting with a painful swelling in the neck who was subsequently detected to be positive for SARS-CoV-2. We seek to highlight the broad clinical spectrum of the COVID-19 by reporting probably the first case of subacute thyroiditis possibly induced by SARS-CoV-2 infection from India.


Asunto(s)
Amidas/administración & dosificación , Azitromicina/administración & dosificación , Prednisolona/administración & dosificación , Pirazinas/administración & dosificación , Glándula Tiroides/diagnóstico por imagen , Tiroiditis Subaguda , Antivirales/administración & dosificación , /diagnóstico , /fisiopatología , Diagnóstico Diferencial , Glucocorticoides/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Cintigrafía/métodos , Pruebas de Función de la Tiroides/métodos , Tiroiditis Subaguda/diagnóstico , Tiroiditis Subaguda/fisiopatología , Tiroiditis Subaguda/terapia , Tiroiditis Subaguda/virología , Resultado del Tratamiento , Ultrasonografía Doppler en Color/métodos
5.
BMB Rep ; 53(10): 545-550, 2020 Nov.
Artículo en Inglés | MEDLINE | ID: covidwho-979311

RESUMEN

Combination therapy using chloroquine (CQ) and azithromycin (AZM) has drawn great attention due to its potential anti-viral activity against SARS-CoV-2. However, clinical trials have revealed that the co-administration of CQ and AZM resulted in severe side effects, including cardiac arrhythmia, in patients with COVID-19. To elucidate the cardiotoxicity induced by CQ and AZM, we examined the effects of these drugs based on the electrophysiological properties of human embryonic stem cellderived cardiomyocytes (hESC-CMs) using multi-electrode arrays. CQ treatment significantly increased the field potential duration, which corresponds to prolongation of the QT interval, and decreased the spike amplitude, spike slope, and conduction velocity of hESC-CMs. AZM had no significant effect on the field potentials of hESC-CMs. However, CQ in combination with AZM greatly increased the field potential duration and decreased the beat period and spike slope of hESC-CMs when compared with CQ monotherapy. In support of the clinical data suggesting the cardiovascular side effects of the combination therapy of CQ and AZM, our results suggest that AZM reinforces the cardiotoxicity induced by CQ in hESC-CMs. [BMB Reports 2020; 53(10): 545-550].


Asunto(s)
Azitromicina/efectos adversos , Cardiotoxicidad/etiología , Cloroquina/efectos adversos , Células Madre Embrionarias/efectos de los fármacos , Miocitos Cardíacos/efectos de los fármacos , Potenciales de Acción , Animales , Arritmias Cardíacas/inducido químicamente , Azitromicina/administración & dosificación , Diferenciación Celular , Cloroquina/administración & dosificación , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/tratamiento farmacológico , Humanos , Ratones , Pandemias , Neumonía Viral/complicaciones , Neumonía Viral/tratamiento farmacológico
6.
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
8.
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
9.
J Cardiovasc Med (Hagerstown) ; 21(11): 922-923, 2020 11.
Artículo en Inglés | MEDLINE | ID: covidwho-868851
10.
BMB Rep ; 53(10): 545-550, 2020 Nov.
Artículo en Inglés | MEDLINE | ID: covidwho-783912

RESUMEN

Combination therapy using chloroquine (CQ) and azithromycin (AZM) has drawn great attention due to its potential anti-viral activity against SARS-CoV-2. However, clinical trials have revealed that the co-administration of CQ and AZM resulted in severe side effects, including cardiac arrhythmia, in patients with COVID-19. To elucidate the cardiotoxicity induced by CQ and AZM, we examined the effects of these drugs based on the electrophysiological properties of human embryonic stem cellderived cardiomyocytes (hESC-CMs) using multi-electrode arrays. CQ treatment significantly increased the field potential duration, which corresponds to prolongation of the QT interval, and decreased the spike amplitude, spike slope, and conduction velocity of hESC-CMs. AZM had no significant effect on the field potentials of hESC-CMs. However, CQ in combination with AZM greatly increased the field potential duration and decreased the beat period and spike slope of hESC-CMs when compared with CQ monotherapy. In support of the clinical data suggesting the cardiovascular side effects of the combination therapy of CQ and AZM, our results suggest that AZM reinforces the cardiotoxicity induced by CQ in hESC-CMs. [BMB Reports 2020; 53(10): 545-550].


Asunto(s)
Azitromicina/efectos adversos , Cardiotoxicidad/etiología , Cloroquina/efectos adversos , Células Madre Embrionarias/efectos de los fármacos , Miocitos Cardíacos/efectos de los fármacos , Potenciales de Acción , Animales , Arritmias Cardíacas/inducido químicamente , Azitromicina/administración & dosificación , Diferenciación Celular , Cloroquina/administración & dosificación , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/tratamiento farmacológico , Humanos , Ratones , Pandemias , Neumonía Viral/complicaciones , Neumonía Viral/tratamiento farmacológico
11.
Cardiol Young ; 30(10): 1482-1485, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: covidwho-669227

RESUMEN

INTRODUCTION AND AIM: Hydroxychloroquine alone or in combination with azithromycin has been increasingly used for patients with coronavirus disease 2019, in both children and adults. Drugs are generally well tolerated in clinical practice; however, both can cause corrected QT prolongation. We aimed to report our experience of QT interval evaluation associated with the use of hydroxychloroquine with concurrent azithromycin among children testing positive for coronavirus disease 2019. METHODS: Our single-centre; retrospective, study evaluated children with coronavirus disease 2019 disease admitted to the Pediatric Department at Sancaktepe Training and Research Hospital Istanbul, Turkey from 10 March, 2020 to 10 April, 2020. The data including demographics, clinical symptoms, co-morbid diseases, laboratory, radiological findings as well as electrocardiographs of the patients were obtained from our records. Electrocardiograms were evaluated before, one day after and at the termination of the treatment. RESULTS: 21 patients aged 9 to 18 years were evaluated. The median age was 170 months (range 112-214), 51.1% of them were girls and 48.9% were boys. Their laboratory results did not reveal any abnormalities. None of them needed intensive care. We did not detect QT prolongation during or at the termination of the treatment. CONCLUSION: We did not detect QT prolongation during or at the termination of the treatment in our patients due to the fact that they were not severely affected by the disease. Patients were treated in our inpatient clinic and none of them required intensive care. Laboratory results were also insignificant. Furthermore, they did not need other medications.


Asunto(s)
Azitromicina , Infecciones por Coronavirus/tratamiento farmacológico , Electrocardiografía/métodos , Hidroxicloroquina , Síndrome de QT Prolongado , Neumonía Viral/tratamiento farmacológico , Adolescente , Antiinfecciosos/administración & dosificación , Antiinfecciosos/efectos adversos , Azitromicina/administración & dosificación , Azitromicina/efectos adversos , Niño , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/epidemiología , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Hidroxicloroquina/administración & dosificación , Hidroxicloroquina/efectos adversos , Síndrome de QT Prolongado/inducido químicamente , Síndrome de QT Prolongado/diagnóstico , Síndrome de QT Prolongado/prevención & control , Masculino , Evaluación de Procesos y Resultados en Atención de Salud , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/epidemiología , Estudios Retrospectivos , Turquia/epidemiología
12.
Toxicol Appl Pharmacol ; 406: 115237, 2020 11 01.
Artículo en Inglés | MEDLINE | ID: covidwho-752826

RESUMEN

Improvement of COVID-19 clinical condition was seen in studies where combination of antiretroviral drugs, lopinavir and ritonavir, as well as immunomodulant antimalaric, chloroquine/hydroxychloroquine together with the macrolide-type antibiotic, azithromycin, was used for patient's treatment. Although these drugs are "old", their pharmacological and toxicological profile in SARS-CoV-2 - infected patients are still unknown. Thus, by using in silico toxicogenomic data-mining approach, we aimed to assess both risks and benefits of the COVID-19 treatment with the most promising candidate drugs combinations: lopinavir/ritonavir and chloroquine/hydroxychloroquine + azithromycin. The Comparative Toxicogenomics Database (CTD; http://CTD.mdibl.org), Cytoscape software (https://cytoscape.org) and ToppGene Suite portal (https://toppgene.cchmc.org) served as a foundation in our research. Our results have demonstrated that lopinavir/ritonavir increased the expression of the genes involved in immune response and lipid metabolism (IL6, ICAM1, CCL2, TNF, APOA1, etc.). Chloroquine/hydroxychloroquine + azithromycin interacted with 6 genes (CCL2, CTSB, CXCL8, IL1B, IL6 and TNF), whereas chloroquine and azithromycin affected two additional genes (BCL2L1 and CYP3A4), which might be a reason behind a greater number of consequential diseases. In contrast to lopinavir/ritonavir, chloroquine/hydroxychloroquine + azithromycin downregulated the expression of TNF and IL6. As expected, inflammation, cardiotoxicity, and dyslipidaemias were revealed as the main risks of lopinavir/ritonavir treatment, while chloroquine/hydroxychloroquine + azithromycin therapy was additionally linked to gastrointestinal and skin diseases. According to our results, these drug combinations should be administrated with caution to patients suffering from cardiovascular problems, autoimmune diseases, or acquired and hereditary lipid disorders.


Asunto(s)
Betacoronavirus , Simulación por Computador , Minería de Datos/métodos , Toxicogenética/métodos , Antivirales/administración & dosificación , Antivirales/efectos adversos , Azitromicina/administración & dosificación , Azitromicina/efectos adversos , Cloroquina/administración & dosificación , Cloroquina/efectos adversos , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/genética , Bases de Datos Genéticas , Quimioterapia Combinada , Redes Reguladoras de Genes/efectos de los fármacos , Redes Reguladoras de Genes/genética , Humanos , Hidroxicloroquina/administración & dosificación , Hidroxicloroquina/efectos adversos , Lopinavir/administración & dosificación , Lopinavir/efectos adversos , Pandemias , Neumonía Viral/tratamiento farmacológico , Neumonía Viral/genética , Ritonavir/administración & dosificación , Ritonavir/efectos adversos
13.
J Cardiovasc Med (Hagerstown) ; 21(10): 765-771, 2020 10.
Artículo en Inglés | MEDLINE | ID: covidwho-745112

RESUMEN

AIMS: The aim of this study was to evaluate the clinical course of COVID-19 in patients who had recently undergone a cardiac procedure and were inpatients in a cardiac rehabilitation department. METHODS: All patients hospitalized from 1 February to 15 March 2020 were included in the study (n = 35; 16 men; mean age 78 years). The overall population was divided into two groups: group 1 included 10 patients who presented with a clinical picture of COVID-19 infection and were isolated, and group 2 included 25 patients who were COVID-19-negative. In group 1, nine patients were on chronic oral anticoagulant therapy and one patient was on acetylsalicylic acid (ASA) and clopidogrel. A chest computed tomography scan revealed interstitial pneumonia in all 10 patients. RESULTS: During hospitalization, COVID-19 patients received azithromycin and hydroxychloroquine in addition to their ongoing therapy. Only the patient on ASA with clopidogrel therapy was transferred to the ICU for mechanical ventilation because of worsening respiratory failure, and subsequently died from cardiorespiratory arrest. All other patients on chronic anticoagulant therapy recovered and were discharged. CONCLUSION: Our study suggests that COVID-19 patients on chronic anticoagulant therapy may have a more favorable and less complicated clinical course. Further prospective studies are warranted to confirm this preliminary observation.


Asunto(s)
Anticoagulantes/uso terapéutico , Azitromicina/administración & dosificación , Procedimientos Quirúrgicos Cardíacos , Infecciones por Coronavirus , Hidroxicloroquina/administración & dosificación , Pandemias , Inhibidores de Agregación Plaquetaria/uso terapéutico , Neumonía Viral , Complicaciones Posoperatorias , Anciano , Antiinfecciosos/administración & dosificación , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/métodos , Terapia Combinada/métodos , Infecciones por Coronavirus/sangre , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/mortalidad , Infecciones por Coronavirus/fisiopatología , Femenino , Humanos , Masculino , Evaluación de Procesos y Resultados en Atención de Salud , Neumonía Viral/sangre , Neumonía Viral/diagnóstico , Neumonía Viral/etiología , Neumonía Viral/mortalidad , Neumonía Viral/fisiopatología , Complicaciones Posoperatorias/sangre , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/virología , Tomografía Computarizada por Rayos X/métodos
14.
PLoS One ; 15(9): e0238681, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-742545

RESUMEN

BACKGROUND: The rapid spread of the disease caused by the novel SARS-CoV-2 virus has led to the use of multiple therapeutic agents whose efficacy has not been previously demonstrated. The objective of this study was to analyze whether there is an association between the use of azithromycin and the evolution of the pulmonary disease or the time to discharge, in patients hospitalized with COVID-19. METHODS: This was an observational study on a cohort of 418 patients admitted to three regional hospitals in Catalonia, Spain. As primary outcomes, we studied the evolution of SAFI ratio (oxygen saturation/fraction of inspired oxygen) in the first 48 hours of treatment and the time to discharge. The results were compared between patients treated and untreated with the study drug through subcohort analyses matched for multiple clinical and prognostic factors, as well as through analysis of non-matched subcohorts, using Cox multivariate models adjusted for prognostic factors. RESULTS: There were 239 patients treated with azithromycin. Of these, 29 patients treated with azithromycin could be matched with an equivalent number of control patients. In the analysis of these matched subcohorts, SAFI at 48h had no significant changes associated to the use of azithromycin, though azithromycin treatment was associated with a longer time to discharge (10.0 days vs 6.7 days; log rank: p = 0.039). However, in the unmatched cohorts, the increased hospital stay associated to azithromycin use, was no significant after adjustment using Multivariate Cox regression models: hazard ratio 1.45 (IC95%: 0.88-2.41; p = 0.150). This study is limited by its small sample size and its observational nature; despite the strong pairing of the matched subcohorts and the adjustment of the Cox regression for multiple factors, the results may be affected by residual confusion. CONCLUSIONS: We did not find a clinical benefit associated with the use of azithromycin, in terms of lung function 48 hours after treatment or length of hospital stay.


Asunto(s)
Antibacterianos/uso terapéutico , Azitromicina/uso terapéutico , Infecciones por Coronavirus/tratamiento farmacológico , Neumonía Viral/tratamiento farmacológico , Anciano , Antibacterianos/administración & dosificación , Azitromicina/administración & dosificación , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pandemias , Alta del Paciente/estadística & datos numéricos
15.
Medicine (Baltimore) ; 99(35): e21810, 2020 Aug 28.
Artículo en Inglés | MEDLINE | ID: covidwho-740205

RESUMEN

RATIONALE: The clinical manifestations of the SARS-CoV-2 infection are mainly respiratory but the virus can cause a variety of symptoms. Dermatological findings are less well-characterized. Data is scarce on their timing, type and correlation with the immune response. PATIENT CONCERNS: We present the case of SARS-CoV-2 infection in a previously healthy woman who presented with respiratory symptoms and developed anosmia, diarrhea, and an erythematous maculo-papular rash on day 15 from symptom onset. DIAGNOSIS: The nasopharyngeal swab tested by real time PCR for COVID-19 was positive. We interpreted this as a viral exanthema likely caused by an immune response to SARS-CoV-2 nucleotides. INTERVENTIONS: She was treated with Hydroxychloroquine, Azithromycin and Lopinavir/Ritonavir, and the rash with topical corticosteroids. OUTCOMES: All symptoms resolved except for anosmia which persisted for 6 weeks. At the 4- and 6-weeks follow-up the IgG titers for SARS-CoV-2 were high. LESSONS: We must consider that SARS-CoV-2 has a multi-organ tropism. In our case, the SARS-CoV-2 infection had lung, nasopharyngeal, neurological, digestive, and skin manifestations. Identifying the different manifestations is useful for understanding the extent of SARS-CoV-2 infection. We not only present a rare manifestation but also suggest that cutaneous manifestations may correlate with immunity.


Asunto(s)
Azitromicina/administración & dosificación , Betacoronavirus , Infecciones por Coronavirus , Exantema , Glucocorticoides/administración & dosificación , Hidroxicloroquina/administración & dosificación , Lopinavir/administración & dosificación , Pandemias , Neumonía Viral , Ritonavir/administración & dosificación , Administración Tópica , Adulto , Antivirales/administración & dosificación , Betacoronavirus/inmunología , Betacoronavirus/aislamiento & purificación , Técnicas de Laboratorio Clínico/métodos , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/fisiopatología , Infecciones por Coronavirus/terapia , Combinación de Medicamentos , Exantema/diagnóstico , Exantema/tratamiento farmacológico , Exantema/etiología , Exantema/inmunología , Femenino , Humanos , Neumonía Viral/diagnóstico , Neumonía Viral/fisiopatología , Neumonía Viral/terapia , Evaluación de Síntomas/métodos , Resultado del Tratamiento
16.
Eur J Med Res ; 25(1): 37, 2020 Aug 27.
Artículo en Inglés | MEDLINE | ID: covidwho-733022

RESUMEN

BACKGROUND: COVID-19 is characterized by fast deterioration in the mechanism of cytokine storm. Therefore, treatment with immunomodulating agents should be initiated as soon as hyperinflammation is established. Evidence for the use of tocilizumab (TCZ) in COVID-19 is emerging, but the drug in this setting is used "off label" with limited data on both effectiveness and safety. Therefore, Hospital for Infectious Diseases in Warsaw established a Standard Operating Procedure (SOP) for the use of TCZ in severe COVID-19 cases. CASE PRESENTATION: Here, we present a case of 27-year-old, otherwise healthy man, who was successfully treated with chloroquine, azithromycin, tocilizumab and a standard of care. Initially the magnitude of lung devastation, clinical deterioration and the need for mechanical ventilation suggested unfavorable prognosis. However, we observed complete regression in radiological changes and rapid clinical improvement. Irrespective of this, patient's serum interleukin 6 and aminotransferases remained elevated even after a month from treatment. CONCLUSIONS: An overlapping effect of hyperinflammation, hypoxic organ injury and drug-related toxicity warrants a long-term follow-up for COVID-19 survivors. In addition, residual IL-6 receptors blockage may mask new infections. A standardized approach to follow-up for COVID-19 survivors is urgently needed. Current and future research should also investigate the impact of experimental therapies on lung tissue healing and regeneration, as well as long-term treatment toxicities.


Asunto(s)
Anticuerpos Monoclonales Humanizados/administración & dosificación , Infecciones por Coronavirus/tratamiento farmacológico , Neumonía Viral/tratamiento farmacológico , Adulto , Azitromicina/administración & dosificación , Betacoronavirus , Cloroquina/administración & dosificación , Infecciones por Coronavirus/diagnóstico por imagen , Citocinas/metabolismo , Humanos , Inflamación , Masculino , Uso Fuera de lo Indicado , Pandemias , Neumonía Viral/diagnóstico por imagen , Polonia , Tomografía Computarizada por Rayos X
17.
Int J Antimicrob Agents ; 56(4): 106142, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: covidwho-726536

RESUMEN

This longitudinal, prospective cohort study aimed to assess risk of QTc interval prolongation and its predicting factors in subjects treated with combinations containing hydroxychloroquine (HCQ) for COVID-19. Moderate-to-severe QTc prolongation during therapy was defined as a QTc interval >470 ms in men or >480 ms in women. Patients were treated under strict cardiac supervision. A total of 105 adults were included [56% male; median (IQR) age 69 (57-79) years]. All patients received therapy with HCQ in combination with azithromycin (AZM), and 95 (90%) also with lopinavir/ritonavir (LPV/r). Concomitant medications classified as having risk of developing torsades de pointes (TdP) were simultaneously used in 81 patients (77%). Moderate-to-severe QTc prolongation was observed in 14 patients (13%), mostly at Days 3-5 from baseline, with 6 (6%) developing severe prolongation (>500 ms). There was no evidence of TdP arrhythmia or TdP-associated death. Adding LPV/r to HCQ+AZM did not significantly prolong the QTc interval. Multivariable Cox regression revealed that comedications with known risk of TdP (HR = 11.28, 95% CI 1.08-117.41), higher neutrophil-to-lymphocyte (NLR) ratio (HR = 1.10, 95% CI 1.03-1.18 per unit increase) and higher serum hs-cardiac troponin I (HR = 4.09, 95% CI 1.36-12.2 per unit increase) were major contributors to moderate-to-severe QTc prolongation. In this closely screened and monitored cohort, no complications derived from QTc prolongation were observed during pharmacological therapy containing HCQ for COVID-19. Evidence of myocardial injury with elevated troponin and strong inflammatory response, specifically higher NLR, are conditions requiring careful QTc interval monitoring.


Asunto(s)
Antiinfecciosos/administración & dosificación , Azitromicina/administración & dosificación , Betacoronavirus/efectos de los fármacos , Infecciones por Coronavirus/tratamiento farmacológico , Hidroxicloroquina/administración & dosificación , Lopinavir/administración & dosificación , Neumonía Viral/tratamiento farmacológico , Ritonavir/administración & dosificación , Anciano , Antiinfecciosos/efectos adversos , Azitromicina/efectos adversos , Betacoronavirus/inmunología , Betacoronavirus/patogenicidad , Biomarcadores/sangre , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/fisiopatología , Infecciones por Coronavirus/virología , Progresión de la Enfermedad , Combinación de Medicamentos , Femenino , Humanos , Hidroxicloroquina/efectos adversos , Unidades de Cuidados Intensivos , Síndrome de QT Prolongado/inducido químicamente , Síndrome de QT Prolongado/diagnóstico , Síndrome de QT Prolongado/fisiopatología , Lopinavir/efectos adversos , Linfocitos/patología , Linfocitos/virología , Masculino , Persona de Mediana Edad , Neutrófilos/patología , Neutrófilos/virología , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/fisiopatología , Neumonía Viral/virología , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Ritonavir/efectos adversos , Resultado del Tratamiento , Troponina I/sangre
18.
Ann Am Thorac Soc ; 17(8): 1008-1015, 2020 08.
Artículo en Inglés | MEDLINE | ID: covidwho-724110

RESUMEN

Coronavirus disease (COVID-19) is a potentially fatal illness with no proven therapy beyond excellent supportive care. Treatments are urgently sought. Adaptations to traditional trial logistics and design to allow rapid implementation, evaluation of trials within a global trials context, flexible interim monitoring, and access outside traditional research hospitals (even in settings where formal placebos are unavailable) may be helpful. Thoughtful adaptations to traditional trial designs, especially within the global context of related studies, may also foster collaborative relationships among government, community, and the research enterprise. Here, we describe the protocol for a pragmatic, active comparator trial in as many as 300 patients comparing two current "off-label" treatments for COVID-19-hydroxychloroquine and azithromycin-in academic and nonacademic hospitals in Utah. We developed the trial in response to local pressures for widespread, indiscriminate off-label use of these medications. We used a hybrid Bayesian-frequentist design for interim monitoring to allow rapid, contextual assessment of the available evidence. We also developed an inference grid for interpreting the range of possible results from this trial within the context of parallel trials and prepared for a network meta-analysis of the resulting data. This trial was prospectively registered (ClinicalTrials.gov Identifier: NCT04329832) before enrollment of the first patient.Clinical trial registered with www.clinicaltrials.gov (NCT04329832).


Asunto(s)
Azitromicina , Infecciones por Coronavirus , Hidroxicloroquina , Pandemias , Neumonía Viral , Adulto , Antiinfecciosos/administración & dosificación , Antiinfecciosos/efectos adversos , Azitromicina/administración & dosificación , Azitromicina/efectos adversos , Betacoronavirus/efectos de los fármacos , Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/epidemiología , Monitoreo de Drogas/métodos , Femenino , Humanos , Hidroxicloroquina/administración & dosificación , Hidroxicloroquina/efectos adversos , Masculino , Neumonía Viral/diagnóstico , Neumonía Viral/tratamiento farmacológico , Neumonía Viral/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Utah
19.
J Cardiovasc Med (Hagerstown) ; 21(11): 922-923, 2020 11.
Artículo en Inglés | MEDLINE | ID: covidwho-691805
20.
N Engl J Med ; 383(21): 2041-2052, 2020 11 19.
Artículo en Inglés | MEDLINE | ID: covidwho-670007

RESUMEN

BACKGROUND: Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited. METHODS: We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed. RESULTS: A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P = 1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P = 1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent. CONCLUSIONS: Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.).


Asunto(s)
Antivirales/administración & dosificación , Azitromicina/administración & dosificación , Infecciones por Coronavirus/tratamiento farmacológico , Hidroxicloroquina/administración & dosificación , Neumonía Viral/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Antivirales/uso terapéutico , Azitromicina/uso terapéutico , Betacoronavirus , Brasil , Quimioterapia Combinada , Femenino , Hospitalización , Humanos , Hidroxicloroquina/uso terapéutico , Masculino , Persona de Mediana Edad , Pandemias , Gravedad del Paciente , Insuficiencia del Tratamiento
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