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临床试验/NCT04535869
NCT04535869Unknown3 期

Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19)

Mansoura University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年12月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
50
试验地点
1
主要终点
rate of virological cure by Rt -PCR for COVID -19using the triple therapy as compared to standard treatment

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 our study is to assess the safety and efficacy of of the addition of HCV treatment to the standard regimen for the treatment of patients according to MOHP protocol.

详细描述

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)] .

However, the first randomized clinical trial with lopinavir/ritonavir demonstrated no benefit over standard care in 199 hospitalized adults with severe COVID-19. There is no evidence to support the use of other antiretrovirals, including protease inhibitors; indeed, structural analysis demonstrates no darunavir binding to COVID-19 protease A group of Korean physicians experienced in SARS-CoV-2 infected patients' treatment developed recommendations for the treatment of COVID-19. According to them, antiviral medications lopinavir 400 mg; ritonavir 100 mg, or chloroquine is considered to be used in older patients or patients with chronic health conditions and life-threatening symptoms. If chloroquine is unavailable, hydroxychloroquine is recommended. Both of them have reported the ability of inhibition of SARS-CoV-2 in vitro.

CPAM guidelines included them as they were associated with reduced progression of the disease and decreased duration of symptoms. In an open-label study of 36 patients with COVID-19, the use of hydroxychloroquine (200 mg three times per day for 10 days) was associated with a higher rate of undetectable SARS-CoV-2 RNA on nasopharyngeal specimens at day 6 compared with no specific treatment (70 versus 12.5 percent). In this study, the use of azithromycin in combination with hydroxychloroquine appeared to have an additional benefit, but there are methodologic concerns about the control groups for the study, and the biologic basis for using azithromycin in this setting is unclear. In the United States, the FDA issued an emergency use authorization to allow the use of these agents in adolescents or adults hospitalized for COVID-19.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All cases positive for COVID-19
  • Male and non-pregnant female patients,
  • 18 years of age or older,
  • All moderate and severe caseswith pneuomnia.

排除标准

  • Known allergy or hypersensitivity to the used medications
  • Known severe liver disease
  • 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

B)Standard Therapy group plus Ant-HCV drugs

Active Comparator

Intervention COVID- 19 patients who received a standard therapy group according to the ministry of health protocol plus sofosbuvir 400 mg and Daclatasvir 200mg

干预措施: Sofosbuvir 400 MG plus Daclatasvir 200mg (Drug)

结局指标

主要结局

rate of virological cure by Rt -PCR for COVID -19using the triple therapy as compared to standard treatment

时间窗: for every case must be done after 2 weeks from the start of treatment.

All PCR for COVID must be negative

次要结局

  • resolution of pneumonia BY high resolution Computed tomography(Computed tomography must be done after 2 weeks to detect resolution of pneumonia)

研究者

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

Mahmoud Elbendary

Professor of Tropical Medicine and Hepatogastroenterology

Mansoura University

研究点 (1)

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