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临床试验/NCT04443725
NCT04443725Unknown2 期

Efficacy and Safety of Anti-hepatitis C Drugs in the Treatment of COVID-19

Cairo University0 个研究点目标入组 100 人开始时间: 2020年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
100
主要终点
Virological cure

研究概览

简要总结

COVID 19 which started from a zoonotic transmission related to crowded markets was confirmed to have a high potential for transmission to close contacts on 20 January 2020 by the National Health Commission of China and it was announced as a pandemic by the WHO on 11 March 2020.

There is currently no clinically proven specific antiviral agent available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, conservation fluid management, and broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important management strategy.

Interestingly, sofosbuvir has recently been proposed as an antiviral for the SARS-CoV-2 based on the similarity between the replication mechanisms of the HCV and the coronaviruses.

Aim of the study is to assess the safety and efficacy of of the addition of HCV treatment to the standard regimen for the treatment of patients who are candidates to receive Hydroxy Chloroquine according to Egyptian MOHP protocol

详细描述

In December, 2019, an outbreak of pneumonia with unknown cause occurred in Wuhan city, the capital of Hubei province in China. On January 7th, the scientists succeeded to isolate a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). WHO nominated it as coronavirus disease 2019 (COVID-19) in February, 2020.

COVID 19 which started from a zoonotic transmission related to crowded markets was confirmed to have a high potential for transmission to close contacts on 20 January 2020 by the National Health Commission of China and it was announced as a pandemic by the WHO on 11 March 2020.

SARS-CoV-2 infection have a wide clinical spectrum ranging between asymptomatic infection, mild upper respiratory tract symptoms, and severe viral pneumonia (fever, malaise, dry cough, shortness of breath, and respiratory distress) that may result in respiratory failure and finally death.

There is currently no clinically proven specific antiviral agent available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, conservation fluid management, and broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important management strategy.

For direct antiviral treatment of SARS-CoV-2, the China International Exchange and Promotive Association for Medical and Health Care (CPAM) recommended usage of lopinavir; ritonavir. Their recommendation was based on weak evidence from retrospective cohort, historically controlled studies, case reports, and case series reporting a clinical benefit of lopinavir; ritonavir in the management of other coronavirus infection [i.e., SARS-CoV 1 and Middle East respiratory syndrome coronavirus (MERS-CoV)] .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • positive reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay for SARS- CoV-2 in a respiratory tract sample

排除标准

  • ● Known allergy or hypersensitivity to the used medications
  • Known severe liver disease (e.g., cirrhosis, with an alanine aminotransferase level >5× the upper limit of the normal range or an aspartate aminotransferase level >5× the upper limit of the normal range)
  • Use of medications that are contraindicated with the trial medications and that could not be replaced or stopped during the trial period
  • Pregnancy or breast-feeding or known active HCV infection, because of concerns about the development of resistance
  • History of bone marrow transplant
  • Known G6PD deficiency
  • Chronic hemodialysis or Glomerular Filtration Rate < 20ml/min
  • Psoriasis
  • Porphyria
  • Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
  • Known history of long QT syndrome
  • Current known QTc>500 msec
  • Pregnant or nursing
  • Weight < 35kg
  • Seizure disorder
  • Patients receiving Amiodarone.

研究组 & 干预措施

Hydroxychloroquine plus Sofosbuvir/Daclatasvir

Experimental

Hydroxychloroquine (hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 14 days, Sofosbuvir 400 mg once daily for 14 days and daclatasvir 90 mg for 14 days

干预措施: Hydroxychloroquine , Sofosbuvir, daclatasvir (Drug)

Standard of care

Active Comparator

Hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 14 days

干预措施: Standard of care treatment (Drug)

结局指标

主要结局

Virological cure

时间窗: 28 days

virological cure using the triple therapy as compared to mono hydroxychloroquine treatment..

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamal Esmat

Professor of Endemic Medicine

Cairo University

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