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

• Status: Not yet recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Hydroxychloroquine; Sofosbuvir

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.