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

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Covid19

Treatments: Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04773756

0305032

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 12 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Sofosbuvir / Daclatsvir

Other group

Description:

A drug used in the treatment of HCV infection, given in the same dose 400mg and 60 mg respectively once daily for 14 days

Treatment:

Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg