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4.
Medwave ; 20(7): e8008, 2020 Aug 28.
Artículo en Español | MEDLINE | ID: covidwho-740553

RESUMEN

In December 2019, a new strain of the SARS-CoV-2 coronavirus was reported in Wuhan, China, which produced severe lung involvement and progressed to respiratory distress. To date, more than seventeen million confirmed cases and more than half a million died worldwide from COVID-19. Patients with cardiovascular disease are more susceptible to contracting this disease and presenting more complications. We did a literature search on the association of cardiovascular disease and COVID-19 in databases such as Scopus, PubMed/MEDLINE, and the Cochrane Library. The purpose of this review is to provide updated information for health professionals who care for patients with COVID-19 and cardiovascular disease, given that they have a high risk of complications and mortality. Treatment with angiotensin-converting enzyme inhibitors and receptor blockers is controversial, and there is no evidence not to use these medications in patients with COVID-19. Regarding treatment with hydroxychloroquine associated or not with azithromycin, there is evidence of a higher risk with its use than clinical benefit and decreased mortality. Likewise, patients with heart failure are an important risk group due to their condition per se. Patients with heart failure and COVID-19 are a diagnostic dilemma because the signs of acute heart failure could be masked. On the other hand, in patients with acute coronary syndrome, the initial therapeutic approach could change in the context of the pandemic, although only based on expert opinions. Nonetheless, many controversial issues will be the subject of future research.


Asunto(s)
Betacoronavirus , Enfermedades Cardiovasculares/complicaciones , Infecciones por Coronavirus/complicaciones , Neumonía Viral/complicaciones , Síndrome Coronario Agudo/etiología , Síndrome Coronario Agudo/terapia , Algoritmos , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Antivirales/efectos adversos , Azitromicina/efectos adversos , Infecciones por Coronavirus/tratamiento farmacológico , Quimioterapia Combinada , Electrocardiografía/efectos de los fármacos , Insuficiencia Cardíaca/etiología , Insuficiencia Cardíaca/terapia , Humanos , Hidroxicloroquina/efectos adversos , Hipertensión/complicaciones , Hipertensión/tratamiento farmacológico , Pandemias , Peptidil-Dipeptidasa A/metabolismo , Neumonía Viral/tratamiento farmacológico , Pronóstico , Sistema Renina-Angiotensina/fisiología
5.
Ann Ital Chir ; 91: 273-276, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-739593

RESUMEN

CASE REPORT: A 64-year-old woman presented to our emergency department during the outbreak of the covid-19 emergency in Italy with syncope, anosmia, mild dyspnoea and atypical chest and dorsal pain. A chest CT scan showed an acute type B aortic dissection (ATBAD) and bilateral lung involvement with ground-glass opacity, compatible with interstitial pneumonia. Nasopharyngeal swabs resulted positive for SARS-CoV-2. For the persistence of chest pain, despite the analgesic therapy, we decided to treat her with a TEVAR. Patient's chest and back pain resolved during the first few days after the procedure. No surgical or respiratory complications occurred and the patient was discharged 14 days after surgery. DISCUSSION: By performing the operation under local anesthesia, it was possible to limit both the staff inside the operatory room and droplet/aerosol release. Since we had to perform the operation in a hemodynamics room, thanks to the limited extension of the endoprosthesis and the good caliber of the right vertebral artery we were able to reduce the risk of spinal cord ischemia despite the lack of a revascularization of the left subclavian artery. CONCLUSIONS: A minimally invasive total endovascular approach allows, through local anesthesia and percutaneous access, to avoid surgical cut down and orotracheal intubation. This, combined with a defined management protocol for infected patients, seems to be a reasonable way to perform endovascular aortic procedures in urgent setting, even in a SARSCoV- 2 positive patient. KEY WORDS: COVID-19, Dissection, TEVAR.


Asunto(s)
Aneurisma Disecante/cirugía , Aneurisma de la Aorta Torácica/cirugía , Betacoronavirus/aislamiento & purificación , Implantación de Prótesis Vascular/métodos , Infecciones por Coronavirus/prevención & control , Procedimientos Endovasculares/métodos , Control de Infecciones/métodos , Transmisión de Enfermedad Infecciosa de Paciente a Profesional/prevención & control , Pandemias/prevención & control , Neumonía Viral/prevención & control , Anestesia Local , Aneurisma Disecante/complicaciones , Profilaxis Antibiótica , Anticoagulantes/uso terapéutico , Antivirales/uso terapéutico , Aneurisma de la Aorta Torácica/complicaciones , Contraindicaciones de los Procedimientos , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/transmisión , Darunavir/uso terapéutico , Diabetes Mellitus Tipo 2/complicaciones , Quimioterapia Combinada , Enoxaparina/uso terapéutico , Femenino , Humanos , Hidroxicloroquina/uso terapéutico , Complicaciones Intraoperatorias/prevención & control , Intubación Intratraqueal/efectos adversos , Persona de Mediana Edad , Nasofaringe/virología , Quirófanos , Aislamiento de Pacientes , Neumonía Viral/complicaciones , Neumonía Viral/tratamiento farmacológico , Neumonía Viral/transmisión , Ritonavir/uso terapéutico , Isquemia de la Médula Espinal/prevención & control , Arteria Vertebral/cirugía
6.
Antimicrob Agents Chemother ; 64(9)2020 08 20.
Artículo en Inglés | MEDLINE | ID: covidwho-729357

RESUMEN

Evidence to support the use of steroids in coronavirus disease 2019 (COVID-19) pneumonia is lacking. We aim to determine the impact of steroid use for COVID-19 pneumonia on hospital mortality. We performed a single-center retrospective cohort study in a university hospital in Madrid, Spain, during March of 2020. To determine the role of steroids in in-hospital mortality, patients admitted with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia and treated with steroids were compared to patients not treated with steroids, and we adjusted with a propensity score for patients on steroid treatment. Survival times were compared using the log rank test. Different steroid regimens were compared and adjusted with a second propensity score. During the study period, 463 out of 848 hospitalized patients with COVID-19 pneumonia fulfilled inclusion criteria. Among them, 396 (46.7%) patients were treated with steroids and 67 patients were not. Global mortality was 15.1%. The median time to steroid treatment from symptom onset was 10 days (interquartile range [IQR], 8 to 13 days). In-hospital mortality was lower in patients treated with steroids than in controls (13.9% [55/396] versus 23.9% [16/67]; hazard ratio [HR], 0.51 [95% confidence interval, 0.27 to 0.96]; P = 0.044). Steroid treatment reduced mortality by 41.8% relative to the mortality with no steroid treatment (relative risk reduction, 0.42 [95% confidence interval, 0.048 to 0.65]). Initial treatment with 1 mg/kg of body weight/day of methylprednisolone versus steroid pulses was not associated with in-hospital mortality (13.5% [42/310] versus 15.1% [13/86]; odds ratio [OR], 0.880 [95% confidence interval, 0.449 to 1.726]; P = 0.710). Our results show that the survival of patients with SARS-CoV-2 pneumonia is higher in patients treated with glucocorticoids than in those not treated. Rates of in-hospital mortality were not different between initial regimens of 1 mg/kg/day of methylprednisolone and glucocorticoid pulses.


Asunto(s)
Antivirales/uso terapéutico , Azitromicina/uso terapéutico , Betacoronavirus/efectos de los fármacos , Infecciones por Coronavirus/tratamiento farmacológico , Hidroxicloroquina/uso terapéutico , Interferones/uso terapéutico , Lopinavir/uso terapéutico , Metilprednisolona/uso terapéutico , Neumonía Viral/tratamiento farmacológico , Ritonavir/uso terapéutico , Anciano , Betacoronavirus/inmunología , Betacoronavirus/patogenicidad , Enfermedades Cardiovasculares/tratamiento farmacológico , Enfermedades Cardiovasculares/inmunología , Enfermedades Cardiovasculares/mortalidad , Enfermedades Cardiovasculares/virología , Comorbilidad , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/mortalidad , Infecciones por Coronavirus/virología , Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/inmunología , Diabetes Mellitus/mortalidad , Diabetes Mellitus/virología , Esquema de Medicación , Combinación de Medicamentos , Quimioterapia Combinada , Dislipidemias/tratamiento farmacológico , Dislipidemias/inmunología , Dislipidemias/mortalidad , Dislipidemias/virología , Femenino , Hospitales Universitarios , Humanos , Unidades de Cuidados Intensivos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Neoplasias/tratamiento farmacológico , Neoplasias/inmunología , Neoplasias/mortalidad , Neoplasias/virología , Pandemias , Neumonía Viral/inmunología , Neumonía Viral/mortalidad , Neumonía Viral/virología , Estudios Retrospectivos , Análisis de Supervivencia
7.
PLoS One ; 15(8): e0237903, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-724760

RESUMEN

AIM: To identify investigated interventions for COVID-19 prevention or treatment via trial registry entries on planned or ongoing randomised clinical trials. To assess these registry entries for recruitment status, planned trial size, blinding and reporting of mortality. METHODS: We identified trial registry entries systematically via the WHO International Clinical Trials Registry Platform and 33 trial registries up to June 23, 2020. We included relevant trial registry entries for randomized clinical trials investigating medical preventive, adjunct or supportive therapies and therapeutics for treatment of COVID-19. Studies with non-random and single-arm design were excluded. Trial registry entries were screened by two authors independently and data were systematically extracted. RESULTS: We included 1303 trial registry entries from 71 countries investigating 381 different single interventions. Blinding was planned in 47% of trials. Sample size was >200 participants in 40% of trials and a total of 611,364 participants were planned for inclusion. Mortality was listed as an outcome in 57% of trials. Recruitment was ongoing in 54% of trials and completed in 8%. Thirty-five percent were multicenter trials. The five most frequent investigational categories were immune modulating drugs (266 trials (20%)), unconventional medicine (167 trials (13%)), antimalarial drugs (118 trials (9%)), antiviral drugs (100 trials (8%)) and respiratory adjuncts (78 trials (6%)). The five most frequently tested uni-modal interventions were: chloroquine/hydroxychloroquine (113 trials with 199,841 participants); convalescent plasma (64 trials with 11,840 participants); stem cells (51 trials with 3,370 participants); tocilizumab (19 trials with 4,139 participants) and favipiravir (19 trials with 3,210 participants). CONCLUSION: An extraordinary number of randomized clinical trials investigating COVID-19 management have been initiated with a multitude of medical preventive, adjunctive and treatment modalities. Blinding will be used in only 47% of trials, which may have influence on future reported treatment effects. Fifty-seven percent of all trials will assess mortality as an outcome facilitating future meta-analyses.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/prevención & control , Pandemias/prevención & control , Neumonía Viral/tratamiento farmacológico , Neumonía Viral/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto , Sistema de Registros , Antibacterianos/uso terapéutico , Antiinflamatorios/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Antimaláricos/uso terapéutico , Antivirales/uso terapéutico , Infecciones por Coronavirus/mortalidad , Infecciones por Coronavirus/virología , Quimioterapia Combinada , Humanos , Hidroxicloroquina/uso terapéutico , Interleucina-6/antagonistas & inhibidores , Neumonía Viral/mortalidad , Neumonía Viral/virología , Resultado del Tratamiento
8.
Eur Rev Med Pharmacol Sci ; 24(15): 8219-8225, 2020 08.
Artículo en Inglés | MEDLINE | ID: covidwho-724284

RESUMEN

OBJECTIVE: At the end of 2019, the Novel Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), spread rapidly from China to the whole world. Circadian rhythms can play crucial role in the complex interplay between viruses and organisms, and temporized schedules (chronotherapy) have been positively tested in several medical diseases. We aimed to compare the possible effects of a morning vs. evening antiviral administration in COVID patients. PATIENTS AND METHODS: We retrospectively evaluated all patients admitted to COVID internal medicine units with confirmed SARS-CoV-2 infection, and treated with darunavir-ritonavir (single daily dose, for seven days). Age, sex, length of stay (LOS), pharmacological treatment, and timing of antiviral administration (morning or evening), were recorded. Outcome indicators were death or LOS, and laboratory parameters, e.g., variations in C-reactive protein (CRP) levels, ratio of arterial oxygen partial pressure (PaO2, mmHg) to fractional inspired oxygen (FiO2) (PaO2/FiO2), and leucocyte count. RESULTS: The total sample consisted of 151 patients, 33 (21.8%) of whom were selected for antiviral treatment. The mean age was 61.8±18.3 years, 17 (51.5%) were male, and the mean LOS was 13.4±8.6 days. Nine patients (27.3%) had their antiviral administration in the morning, and 24 (72.7%) had antiviral administration in the evening. No fatalities occurred. Despite the extremely limited sample size, morning group subjects showed a significant difference in CRP variation, compared to that in evening group subjects (-65.82±33.26 vs. 83.32±304.89, respectively, p<0.032). No significant differences were found for other parameters. CONCLUSIONS: This report is the first study evaluating temporized morning vs. evening antiviral administration in SARS-CoV-2 patients. The morning regimen was associated with a significant reduction in CRP values. Further confirmations with larger and multicenter samples of patients could reveal novel potentially useful insights.


Asunto(s)
Antivirales/administración & dosificación , Infecciones por Coronavirus/tratamiento farmacológico , Darunavir/administración & dosificación , Cronoterapia de Medicamentos , Mortalidad Hospitalaria , Tiempo de Internación/estadística & datos numéricos , Neumonía Viral/tratamiento farmacológico , Ritonavir/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Betacoronavirus , Análisis de los Gases de la Sangre , Proteína C-Reactiva , Infecciones por Coronavirus/metabolismo , Quimioterapia Combinada , Humanos , Italia , Recuento de Leucocitos , Persona de Mediana Edad , Oxígeno/metabolismo , Pandemias , Presión Parcial , Neumonía Viral/metabolismo , Estudios Retrospectivos
9.
PLoS One ; 15(8): e0237693, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-713539

RESUMEN

Hydroxychloroquine has been touted as a potential COVID-19 treatment. Tocilizumab, an inhibitor of IL-6, has also been proposed as a treatment of critically ill patients. In this retrospective observational cohort study drawn from electronic health records we sought to describe the association between mortality and hydroxychloroquine or tocilizumab therapy among hospitalized COVID-19 patients. Patients were hospitalized at a 13-hospital network spanning New Jersey USA between March 1, 2020 and April 22, 2020 with positive polymerase chain reaction results for SARS-CoV-2. Follow up was through May 5, 2020. Among 2512 hospitalized patients with COVID-19 there have been 547 deaths (22%), 1539 (61%) discharges and 426 (17%) remain hospitalized. 1914 (76%) received at least one dose of hydroxychloroquine and 1473 (59%) received hydroxychloroquine with azithromycin. After adjusting for imbalances via propensity modeling, compared to receiving neither drug, there were no significant differences in associated mortality for patients receiving any hydroxychloroquine during the hospitalization (HR, 0.99 [95% CI, 0.80-1.22]), hydroxychloroquine alone (HR, 1.02 [95% CI, 0.83-1.27]), or hydroxychloroquine with azithromycin (HR, 0.98 [95% CI, 0.75-1.28]). The 30-day unadjusted mortality for patients receiving hydroxychloroquine alone, azithromycin alone, the combination or neither drug was 25%, 20%, 18%, and 20%, respectively. Among 547 evaluable ICU patients, including 134 receiving tocilizumab in the ICU, an exploratory analysis found a trend towards an improved survival association with tocilizumab treatment (adjusted HR, 0.76 [95% CI, 0.57-1.00]), with 30 day unadjusted mortality with and without tocilizumab of 46% versus 56%. This observational cohort study suggests hydroxychloroquine, either alone or in combination with azithromycin, was not associated with a survival benefit among hospitalized COVID-19 patients. Tocilizumab demonstrated a trend association towards reduced mortality among ICU patients. Our findings are limited to hospitalized patients and must be interpreted with caution while awaiting results of randomized trials. Trial Registration: Clinicaltrials.gov Identifier: NCT04347993.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Antimaláricos/uso terapéutico , Betacoronavirus , Infecciones por Coronavirus/tratamiento farmacológico , Hidroxicloroquina/uso terapéutico , Neumonía Viral/tratamiento farmacológico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/farmacología , Azitromicina/uso terapéutico , Niño , Preescolar , Infecciones por Coronavirus/mortalidad , Infecciones por Coronavirus/virología , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Hospitalización , Humanos , Lactante , Recién Nacido , Unidades de Cuidados Intensivos , Interleucina-6/antagonistas & inhibidores , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Pandemias , Neumonía Viral/mortalidad , Neumonía Viral/virología , Estudios Retrospectivos , Resultado del Tratamiento , Adulto Joven
10.
Cells ; 9(8)2020 08 11.
Artículo en Inglés | MEDLINE | ID: covidwho-706247

RESUMEN

The development of biological disease-modifying antirheumatic drugs (bDMARDs) and target synthetic DMARDs (tsDMARDs), also known as small molecule inhibitors, represent a breakthrough in rheumatoid arthritis (RA) treatment. The tsDMARDs are a large family of small molecules targeting mostly the several types of kinases, which are essential in downstream signaling of pro-inflammatory molecules. This review highlights current challenges associated with the treatment of RA using small molecule inhibitors targeting intracellular JAKs/MAPKs/NF-κB/SYK-BTK signaling pathways. Indeed, we have provided the latest update on development of small molecule inhibitors, their clinical efficacy and safety as a strategy for RA treatment. On the other hand, we have highlighted the risk and adverse effects of tsDMARDs administration including, among others, infections and thromboembolism. Therefore, performance of blood tests or viral infection screening should be recommended before the tsDMARDs administration. Interestingly, recent events of SARS-CoV-2 outbreak have demonstrated the potential use of small molecule inhibitors not only in RA treatment, but also in fighting COVID-19 via blocking the viral entry, preventing of hyperimmune activation and reducing cytokine storm. Thus, small molecule inhibitors, targeting wide range of pro-inflammatory singling pathways, may find wider implications not only for the management of RA but also in the controlling of COVID-19.


Asunto(s)
Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Betacoronavirus/fisiología , Infecciones por Coronavirus/tratamiento farmacológico , Neumonía Viral/tratamiento farmacológico , Animales , Betacoronavirus/efectos de los fármacos , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/virología , Citocinas/inmunología , Citocinas/metabolismo , Quimioterapia Combinada , Humanos , Inflamación/inmunología , Inflamación/metabolismo , Ratones , Pandemias , Neumonía Viral/inmunología , Neumonía Viral/virología , Transducción de Señal/efectos de los fármacos , Resultado del Tratamiento , Internalización del Virus/efectos de los fármacos
11.
Medicine (Baltimore) ; 99(32): e21570, 2020 Aug 07.
Artículo en Inglés | MEDLINE | ID: covidwho-706114

RESUMEN

RATIONALE: Macrophage activation syndrome (MAS) is a rare life-threatening condition characterized by cytokine-mediated tissue injury and multiorgan dysfunction. PATIENT CONCERNS: We describe the unique case of young man who developed MAS as the sole manifestation of an otherwise paucisymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. DIAGNOSES: Clinical and biological criteria led to the diagnosis of MAS; cytokine profile was highly suggestive reverse transcription polymerase chain reaction for SARS-CoV-2 in nasopharyngeal swabs was negative, but serum anti-SARS-CoV-2 immunoglobulin A and immunoglobulin G resulted positive leading to the diagnosis of SARS-CoV-2 infection. INTERVENTIONS: The patient was treated with empiric antibiotic and hydroxychloroquine. OUTCOMES: Clinical improvement ensued. At follow-up, the patient is well. LESSON: SARS-CoV-2 infection may trigger develop life-threatening complications, like MAS. This can be independent from coronavirus disease 2019 gravity.


Asunto(s)
Ceftriaxona/administración & dosificación , Infecciones por Coronavirus/diagnóstico , Hospitalización , Hidroxicloroquina/administración & dosificación , Síndrome de Activación Macrofágica/diagnóstico , Neumonía Viral/diagnóstico , Adolescente , Análisis Químico de la Sangre , China , Técnicas de Laboratorio Clínico/métodos , Infecciones por Coronavirus/tratamiento farmacológico , ADN Viral/análisis , Diagnóstico Diferencial , Progresión de la Enfermedad , Quimioterapia Combinada , Electrocardiografía/métodos , Estudios de Seguimiento , Humanos , Síndrome de Activación Macrofágica/terapia , Masculino , Pandemias , Alta del Paciente , Neumonía Viral/tratamiento farmacológico , Radiografía Torácica/métodos , Reacción en Cadena en Tiempo Real de la Polimerasa/métodos , Medición de Riesgo , Índice de Severidad de la Enfermedad , Tomografía Computarizada por Rayos X/métodos , Resultado del Tratamiento
12.
J Antimicrob Chemother ; 75(9): 2657-2660, 2020 09 01.
Artículo en Inglés | MEDLINE | ID: covidwho-705983

RESUMEN

BACKGROUND: The combination lopinavir/ritonavir is recommended to treat HIV-infected patients at the dose regimen of 400/100 mg q12h, oral route. The usual lopinavir trough plasma concentrations are 3000-8000 ng/mL. A trend towards a 28 day mortality reduction was observed in COVID-19-infected patients treated with lopinavir/ritonavir. OBJECTIVES: To assess the plasma concentrations of lopinavir and ritonavir in patients with severe COVID-19 infection and receiving lopinavir/ritonavir. PATIENTS AND METHODS: Mechanically ventilated patients with COVID-19 infection included in the French COVID-19 cohort and treated with lopinavir/ritonavir were included. Lopinavir/ritonavir combination was administered using the usual adult HIV dose regimen (400/100 mg q12h, oral solution through a nasogastric tube). A half-dose reduction to 400/100 mg q24h was proposed if lopinavir Ctrough was >8000 ng/mL, the upper limit considered as toxic and reported in HIV-infected patients. Lopinavir and ritonavir pharmacokinetic parameters were determined after an intensive pharmacokinetic analysis. Biological markers of inflammation and liver/kidney function were monitored. RESULTS: Plasma concentrations of lopinavir and ritonavir were first assessed in eight patients treated with lopinavir/ritonavir. Median (IQR) lopinavir Ctrough reached 27 908 ng/mL (15 928-32 627). After the dose reduction to 400/100 mg q24h, lopinavir/ritonavir pharmacokinetic parameters were assessed in nine patients. Lopinavir Ctrough decreased to 22 974 ng/mL (21 394-32 735). CONCLUSIONS: In mechanically ventilated patients with severe COVID-19 infections, the oral administration of lopinavir/ritonavir elicited plasma exposure of lopinavir more than 6-fold the upper usual expected range. However, it remains difficult to safely recommend its dose reduction without compromising the benefit of the antiviral strategy, and careful pharmacokinetic and toxicity monitoring are needed.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/sangre , Unidades de Cuidados Intensivos/tendencias , Lopinavir/sangre , Neumonía Viral/sangre , Respiración Artificial/tendencias , Ritonavir/sangre , Administración Oral , Infecciones por Coronavirus/tratamiento farmacológico , Inhibidores del Citocromo P-450 CYP3A/administración & dosificación , Inhibidores del Citocromo P-450 CYP3A/sangre , Quimioterapia Combinada , Femenino , Humanos , Lopinavir/administración & dosificación , Masculino , Persona de Mediana Edad , Pandemias , Soluciones Farmacéuticas/administración & dosificación , Soluciones Farmacéuticas/farmacocinética , Neumonía Viral/tratamiento farmacológico , Estudios Prospectivos , Ritonavir/administración & dosificación
13.
Rev Peru Med Exp Salud Publica ; 37(2): 356-360, 2020.
Artículo en Español | MEDLINE | ID: covidwho-699404

RESUMEN

COVID-19 represents a global crisis. Rapidly conducting a clinical trial with the rigor necessary to obtain reliable results requires the collaboration of various participants involved in the development, evaluation and authorization of clinical trials (CT) such as the trial sponsor, researchers, regulatory authority and the ethics committee (EC). Carrying out these studies is not only scientifically appropriate, but an ethical and moral obligation to guarantee our patients effective treatment. SOLIDARITY is a mega clinical trial that recruited thousands of subjects with moderate to severe disease, who were randomly assigned to one of the treatment groups under evaluation, including hydroxychloroquine, lopinavir/ritonavir associated or not with interferon; or remdesivir compared to standard therapy. Peru has joined the list of countries where the trial will be reproduced, through which it will be possible to quickly identify if any of these drugs offers a real benefit to patients.


Asunto(s)
Antivirales/administración & dosificación , Infecciones por Coronavirus/tratamiento farmacológico , Neumonía Viral/tratamiento farmacológico , Infecciones por Coronavirus/fisiopatología , Quimioterapia Combinada , Humanos , Cooperación Internacional , Pandemias , Perú , Neumonía Viral/fisiopatología , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
14.
Nat Rev Immunol ; 20(9): 515-516, 2020 09.
Artículo en Inglés | MEDLINE | ID: covidwho-690707

Asunto(s)
Antioxidantes/uso terapéutico , Betacoronavirus/patogenicidad , Infecciones por Coronavirus/tratamiento farmacológico , Pulmón/inmunología , Neutrófilos/efectos de los fármacos , Neumonía Viral/tratamiento farmacológico , Acetilcisteína/uso terapéutico , Betacoronavirus/efectos de los fármacos , Betacoronavirus/inmunología , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/virología , Citocinas/genética , Citocinas/inmunología , Quimioterapia Combinada , Trampas Extracelulares/efectos de los fármacos , Trampas Extracelulares/inmunología , Trampas Extracelulares/metabolismo , Regulación de la Expresión Génica , Glicina/análogos & derivados , Glicina/uso terapéutico , Interacciones Huésped-Patógeno/efectos de los fármacos , Humanos , Inmunidad Innata/efectos de los fármacos , Pulmón/efectos de los fármacos , Pulmón/patología , Pulmón/virología , Linfocitos/efectos de los fármacos , Linfocitos/inmunología , Linfocitos/virología , Factor 2 Relacionado con NF-E2/genética , Factor 2 Relacionado con NF-E2/inmunología , FN-kappa B/genética , FN-kappa B/inmunología , Neutrófilos/inmunología , Neutrófilos/virología , Estrés Oxidativo/efectos de los fármacos , Pandemias , Neumonía Viral/inmunología , Neumonía Viral/virología , Proteínas Inhibidoras de Proteinasas Secretoras/uso terapéutico , Especies Reactivas de Oxígeno/antagonistas & inhibidores , Especies Reactivas de Oxígeno/inmunología , Especies Reactivas de Oxígeno/metabolismo , Índice de Severidad de la Enfermedad , Sulfonamidas/uso terapéutico , Superóxido Dismutasa/genética , Superóxido Dismutasa/inmunología
15.
Medicine (Baltimore) ; 99(30): e21404, 2020 Jul 24.
Artículo en Inglés | MEDLINE | ID: covidwho-684117

RESUMEN

BACKGROUND: The novel coronavirus pneumonia (COVID-19) has spread to >200 countries and regions. There is no effective antiviral drug for COVID-19. Traditional Chinese medicine, such as Lianhua Qingwen, has achieved some curative effect in many countries, but its effect is not clear. We aim to assess the efficacy and safety of Lianhua Qingwen combined with Conventional antiviral Western Medicine in Clinical treatment of COVID-19 or asymptomatic infection. METHODS: The following electronic bibliographic databases will be searched to identify relevant studies: CNKI, CBM, VIP and Wanfang databases, PubMed, EMBASE, MEDLINE, Cochrane central, and clinical trial registration centers, such as China Clinical Trial Registration Center (ChiCTR), Netherlands National Trial Registration Center (NTR) and clinical trials.gov. In addition, Manual retrieval of articles, conference papers, ongoing experiments, internal reports, among others, to supplement electronic retrieval. Select all eligible studies published before May 8, 2020.According to the Cochrane Handbook "bias risk" assessment tool, bias risk is independently assessed. The independent Newcastle Ottawa scale was used to conduct methodological quality assessment of nonrandomized trials. STATA15.1 and RevMan5.3 software were used to analyze meta outcomes of different intervention measures for the treatment of new crown pneumonia and the control group (conventional antiviral western medicine treatment) clinical efficacy. RESULTS: This study will provide a relatively high-quality synthesis of current evidence of Lianhua Qingwen combined with Conventional antiviral Western Medicine in the treatment of COVID-19 from several aspects including the Clinical effective rate, CT improvement rate, severe conversion rate, antipyretic time, disappearance rate of fever symptoms, disappearance rate of cough symptoms, disappearance rate of asthenia symptoms, and adverse drug events. CONCLUSION: The conclusion of this review will provide evidence to judge whether Lianhua Qingwen combined with Conventional antiviral Western Medicine is an effective and safe intervention for COVID-19. ETHICS AND DISSEMINATION: This systemic review will evaluate the efficacy and safety of Lianhua Qingwen combined with Conventional antiviral Western Medicine in the treatment of COVID-19. Since all the data included are published, the systematic review does not need ethical approval. INPLASY REGISTRATION NUMBER: INPLASY202060067.


Asunto(s)
Antivirales/administración & dosificación , Betacoronavirus , Infecciones por Coronavirus/tratamiento farmacológico , Medicamentos Herbarios Chinos/administración & dosificación , Neumonía Viral/tratamiento farmacológico , Infecciones por Coronavirus/virología , Quimioterapia Combinada , Humanos , Metaanálisis como Asunto , Pandemias , Neumonía Viral/virología , Proyectos de Investigación , Revisiones Sistemáticas como Asunto , Resultado del Tratamiento
16.
Medicine (Baltimore) ; 99(30): e21402, 2020 Jul 24.
Artículo en Inglés | MEDLINE | ID: covidwho-683935

RESUMEN

BACKGROUND: Coronavirus disease 2019 (COVID-19) is highly contagious, and the epidemic has spread to hundreds of countries around the world, and seriously threatens the life safety of people around the world. Arbidol is an antiviral drug with high potential against COVID-19, but evidence of effectiveness and safety is lacking. The systematic review protocol aims to formulate a research plan that can evaluate the efficacy and safety of arbidol for COVID-19. METHODS: The retrieval time will be from the database establishment to June 2020. The retrieval database will include the Cochrane Library, PubMed, Embase, OVID, CNKI, Wanfang, VIP, CBM, etc. The primary outcome will be clinical efficacy, and the secondary results will be accompanying symptoms, time for the temperature to return to normal, time of novel coronavirus nucleic acid turning negative, blood sample test, Computed Tomography examination, length of hospitalization, adverse reactions, and adverse events. RevManV.5.3 software will be used for meta-analysis, and fixed effects model, random-effects model, subgroup analysis, and descriptive analysis will be adopted according to the heterogeneity of the research results. RESULTS: To provide the latest evidence of clinical efficacy and safety of arbidol in the treatment of COVID-19. CONCLUSION: Our study will provide the latest evidence analysis of the efficacy and safety of arbidol for COVID-19, to provide evidence-based medicine for the prevention and control of this epidemic. REGISTRATION DETAILS: PROSPERO CRD42020189203.


Asunto(s)
Antivirales/uso terapéutico , Betacoronavirus , Infecciones por Coronavirus/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Indoles/uso terapéutico , Neumonía Viral/tratamiento farmacológico , Infecciones por Coronavirus/virología , Quimioterapia Combinada , Humanos , Pandemias , Neumonía Viral/virología , Resultado del Tratamiento
17.
Trials ; 21(1): 646, 2020 Jul 14.
Artículo en Inglés | MEDLINE | ID: covidwho-670196

RESUMEN

OBJECTIVES: To determine if lopinavir/ritonavir +/- hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection. TRIAL DESIGN: ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled trial. Participants will have been hospitalised with confirmed COVID-19, and will be randomised 1:1:1:1 to receive lopinavir /ritonavir, hydroxychloroquine, both or neither drug in addition to standard of care management. PARTICIPANTS: Participants will be recruited from >80 hospitals across Australia and New Zealand, representing metropolitan and regional centres in both public and private sectors. Admitted patients will be eligible if aged ≥ 18 years, have confirmed SARS-CoV-2 by nucleic acid testing in the past 12 days and are expected to remain an inpatient for at least 48 hours from the time of randomisation. Potentially eligible participants will be excluded if admitted to intensive care or requiring high level respiratory support, are currently receiving study drugs or their use is contraindicated due to allergy, drug interaction or comorbidities (including baseline QTc prolongation of 470ms for women or 480ms for men), or death is anticipated imminently. INTERVENTION AND COMPARATOR: Participants will be randomised 1:1:1:1 to: Group 1: standard of care; Group 2: lopinavir (400mg) / ritonavir (100mg) twice daily for 10 days in tablet form; Group 3: hydroxychloroquine (800mg) 4x200mg administered 12 hours apart on Day 1, followed by 400mg twice a day for 6 days; Group 4: lopinavir /ritonavir plus hydroxychloroquine. MAIN OUTCOMES: Proportion of participants alive and not having required intensive respiratory support (invasive or non-invasive ventilation) at 15 days after enrolment. A range of clinical and virological secondary outcomes will also be evaluated. RANDOMISATION: The randomisation schedule will be generated by an independent statistician. Randomisation will be stratified by site and will be in permuted blocks of variable block size. The randomised sequence allocation will only be accessible to the data management group, and site investigators will have individual participant allocation provided through a web-based trial enrolment platform. BLINDING (MASKING): This is an open-label study, with researchers assessing the laboratory outcomes blinded to treatment allocation. No unblinding procedures relating to potential adverse effects are therefore required. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): We assumed that 5% of participants receiving standard of care would meet the primary outcome, aimed to evaluate whether interventions could lead to a relative risk of 0.5, assuming no interaction between intervention arms. This corresponds to a required sample size of 610 per arm, with a 5% two-sided significance level (alpha) and 80% power. The total sample size therefore is planned to be 2440. TRIAL STATUS: ASCOT protocol version 3, May 5, 2020. Recruitment opened April 4, 2020 and is ongoing, with planned completion of enrolment July 31, 2021. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12620000445976 ). Prospectively registered April 6, 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)
Betacoronavirus , Infecciones por Coronavirus/tratamiento farmacológico , Hidroxicloroquina/administración & dosificación , Lopinavir/administración & dosificación , Neumonía Viral/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Ritonavir/administración & dosificación , Nivel de Atención , Quimioterapia Combinada , Hospitalización , Humanos , Pandemias
18.
Food Chem Toxicol ; 144: 111639, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: covidwho-664077

RESUMEN

On 11th March 2020, the pandemic of the new coronavirus was declared by the World Health Organization. At the moment, there are no new registered medicines that can effectively treat the coronavirus infection. However, a number of ongoing clinical trials are investigating the efficacy and safety of the medicines which have already been registered and used for the treatment of other diseases, in the treatment of the coronavirus infection. The proposed combinations of these medicines could potentially present a safety risk, since most of these medicines have the potential to cause numerous side or toxic effects, even when used in monotherapy. Thus, the aim of this study was to review and evaluate the literature data on the toxicity of the selected individual drugs (ritonavir, lopinavir, remdesivir, chloroquine, and umifenovir) and the available clinical data concerning the possible adverse effects of the selected drug combinations (lopinavir/ritonavir + umifenovir, lopinavir/ritonavir + interferon ß, chloroquine + remdesivir, and chloroquine + azithromycin). The most often reported toxic effects of these medicines such as hepatotoxicity, retinal damage, nephrotoxicity, and cardiotoxicity, together with the fact that the health status of the patients with COVID-19 disease is often complicated by co-existing illnesses and therapy implicate that the decision on the therapeutic strategy should be made with caution.


Asunto(s)
Antivirales/efectos adversos , Antivirales/uso terapéutico , Infecciones por Coronavirus/tratamiento farmacológico , Neumonía Viral/tratamiento farmacológico , Animales , Cloroquina/efectos adversos , Cloroquina/uso terapéutico , Quimioterapia Combinada , Humanos , Pandemias , Seguridad del Paciente
19.
Antimicrob Agents Chemother ; 64(9)2020 08 20.
Artículo en Inglés | MEDLINE | ID: covidwho-663333

RESUMEN

To the best of our knowledge, there is no published study on the use of interferon ß-1a (IFN ß-1a) in the treatment of severe COVID-19. In this randomized clinical trial, the efficacy and safety of IFN ß-1a were evaluated in patients with severe COVID-19. Forty-two patients in the interferon group received IFN ß-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir-ritonavir or atazanavir-ritonavir). Each 44-µg/ml (12 million IU/ml) dose of interferon ß-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group consisted of 39 patients who received only the national protocol medications. The primary outcome of the study was time to reach clinical response. Secondary outcomes were duration of hospital stay, length of intensive care unit stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects, and complications during the hospitalization. Between 29 February and 3 April 2020, 92 patients were recruited, and a total of 42 patients in the IFN group and 39 patients in the control group completed the study. As the primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 ± 5.8 versus 8.3 ± 4.9 days, respectively, P = 0.95). On day 14, 66.7% versus 43.6% of patients in the IFN group and the control group, respectively, were discharged (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.05 to 6.37). The 28-day overall mortality was significantly lower in the IFN than the control group (19% versus 43.6%, respectively, P = 0.015). Early administration significantly reduced mortality (OR, 13.5; 95% CI, 1.5 to 118). Although IFN did not change the time to reach the clinical response, adding it to the national protocol significantly increased discharge rate on day 14 and decreased 28-day mortality. (This study is in the Iranian Registry of Clinical Trials under identifier IRCT20100228003449N28.).


Asunto(s)
Antivirales/uso terapéutico , Sulfato de Atazanavir/uso terapéutico , Betacoronavirus/efectos de los fármacos , Infecciones por Coronavirus/tratamiento farmacológico , Interferón beta-1a/uso terapéutico , Lopinavir/uso terapéutico , Neumonía Viral/tratamiento farmacológico , Ritonavir/uso terapéutico , Adulto , Anciano , Betacoronavirus/inmunología , Betacoronavirus/patogenicidad , Enfermedades Cardiovasculares/tratamiento farmacológico , Enfermedades Cardiovasculares/inmunología , Enfermedades Cardiovasculares/mortalidad , Enfermedades Cardiovasculares/virología , Comorbilidad , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/mortalidad , Infecciones por Coronavirus/virología , Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/inmunología , Diabetes Mellitus/mortalidad , Diabetes Mellitus/virología , Esquema de Medicación , Combinación de Medicamentos , Quimioterapia Combinada , Dislipidemias/tratamiento farmacológico , Dislipidemias/inmunología , Dislipidemias/mortalidad , Dislipidemias/virología , Femenino , Humanos , Hidroxicloroquina/uso terapéutico , Unidades de Cuidados Intensivos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Neoplasias/tratamiento farmacológico , Neoplasias/inmunología , Neoplasias/mortalidad , Neoplasias/virología , Pandemias , Seguridad del Paciente , Neumonía Viral/inmunología , Neumonía Viral/mortalidad , Neumonía Viral/virología , Análisis de Supervivencia , Resultado del Tratamiento
20.
J Antimicrob Chemother ; 75(9): 2657-2660, 2020 09 01.
Artículo en Inglés | MEDLINE | ID: covidwho-657048

RESUMEN

BACKGROUND: The combination lopinavir/ritonavir is recommended to treat HIV-infected patients at the dose regimen of 400/100 mg q12h, oral route. The usual lopinavir trough plasma concentrations are 3000-8000 ng/mL. A trend towards a 28 day mortality reduction was observed in COVID-19-infected patients treated with lopinavir/ritonavir. OBJECTIVES: To assess the plasma concentrations of lopinavir and ritonavir in patients with severe COVID-19 infection and receiving lopinavir/ritonavir. PATIENTS AND METHODS: Mechanically ventilated patients with COVID-19 infection included in the French COVID-19 cohort and treated with lopinavir/ritonavir were included. Lopinavir/ritonavir combination was administered using the usual adult HIV dose regimen (400/100 mg q12h, oral solution through a nasogastric tube). A half-dose reduction to 400/100 mg q24h was proposed if lopinavir Ctrough was >8000 ng/mL, the upper limit considered as toxic and reported in HIV-infected patients. Lopinavir and ritonavir pharmacokinetic parameters were determined after an intensive pharmacokinetic analysis. Biological markers of inflammation and liver/kidney function were monitored. RESULTS: Plasma concentrations of lopinavir and ritonavir were first assessed in eight patients treated with lopinavir/ritonavir. Median (IQR) lopinavir Ctrough reached 27 908 ng/mL (15 928-32 627). After the dose reduction to 400/100 mg q24h, lopinavir/ritonavir pharmacokinetic parameters were assessed in nine patients. Lopinavir Ctrough decreased to 22 974 ng/mL (21 394-32 735). CONCLUSIONS: In mechanically ventilated patients with severe COVID-19 infections, the oral administration of lopinavir/ritonavir elicited plasma exposure of lopinavir more than 6-fold the upper usual expected range. However, it remains difficult to safely recommend its dose reduction without compromising the benefit of the antiviral strategy, and careful pharmacokinetic and toxicity monitoring are needed.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/sangre , Unidades de Cuidados Intensivos/tendencias , Lopinavir/sangre , Neumonía Viral/sangre , Respiración Artificial/tendencias , Ritonavir/sangre , Administración Oral , Infecciones por Coronavirus/tratamiento farmacológico , Inhibidores del Citocromo P-450 CYP3A/administración & dosificación , Inhibidores del Citocromo P-450 CYP3A/sangre , Quimioterapia Combinada , Femenino , Humanos , Lopinavir/administración & dosificación , Masculino , Persona de Mediana Edad , Pandemias , Soluciones Farmacéuticas/administración & dosificación , Soluciones Farmacéuticas/farmacocinética , Neumonía Viral/tratamiento farmacológico , Estudios Prospectivos , Ritonavir/administración & dosificación
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