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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04443725
Recruitment Status : Not yet recruiting
First Posted : June 23, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Gamal Esmat, Cairo University

Brief Summary:

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


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine , Sofosbuvir, daclatasvir Drug: Standard of care treatment Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Anti-hepatitis C Drugs in the Treatment of COVID-19
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine plus Sofosbuvir/Daclatasvir
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
Drug: Hydroxychloroquine , Sofosbuvir, daclatasvir
Hydroxychloroquine (hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 14 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate) <50ml/min) alone; as provided by the MOHP protocol), Sofosbuvir 400 mg once daily for 14 days and daclatasvir 90 mg for 14 days.

Active Comparator: Standard of care
Hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 14 days
Drug: Standard of care treatment
Hydroxychloroquine (hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 14 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate) <50ml/min) alone; as provided by the MOHP protocol),




Primary Outcome Measures :
  1. Virological cure [ Time Frame: 28 days ]
    virological cure using the triple therapy as compared to mono hydroxychloroquine treatment..



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • ● 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.
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Responsible Party: Gamal Esmat, Professor of Endemic Medicine, Cairo University
ClinicalTrials.gov Identifier: NCT04443725    
Other Study ID Numbers: CUKA-003
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydroxychloroquine
Sofosbuvir
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Antiviral Agents