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NCT04773756 Clinical Trial

Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt

Covid19 Clinical Trial

Official title:
Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt (Single Center Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04773756
Other study ID # 0305032
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 1, 2020
Est. completion date December 12, 2020

Study information
Verified date February 2021
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sofosbuvir has been recently recommended as a possible antiviral for COVID-19, based on structural studies and multiple alignment analysis. By comparing the positive-stranded RNA genomes of HCV and SARS-CoV-2, it has been postulated that sofosbuvir might be an optimal nucleotide analogue to repurpose for COVID-19 treatment

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date December 12, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years to 90 Years
Eligibility Inclusion Criteria: - mild- moderate COVID-19 confirmed by PCR Exclusion Criteria: 1. Patients on renal dialysis 2. Severe COVID-19 cases 3. Patients on amiodarone therapy (given the reported FDA warning of an interaction between amiodarone and sofosbuvir that might lead to severe bradycardia). 4. Children < 12 years 5. Pregnant and breast feeding women 6. Exacerbation of hepatitis B

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sofosbuvir 400 MG/ Daclatasvir 60mg
Giving these two drugs for treatment of COVID patients

Locations
Country Name City State
Egypt Amr Aly Abd elmoety Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19. The study assesses the incidence of resolution of symptoms in COVID patients after taking Sofosbuvir and Daclatasvir for 14 days by doing PCR and the result to be negative it is estimated to be 2 weeks
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