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CompletedNCT04773756Updated Feb 26, 2021

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

A Phase 4 interventional study of Sofosbuvir 400 MG/ Daclatasvir 60mg in Covid19, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 12 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-02-26.

Sponsored by Alexandria University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2020, 5 years 10 months ago, and no results have been posted to the registry.
  • Registered 3 months after the study started (first participant enrolled Nov 2020, registered Feb 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
12 Years to 90 Years
Sex
All
01

Study 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

02

Conditions studied

  • Covid19

Keywords

  • Sofosbuvir
  • Daclatasvir
03

In context

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • mild- moderate COVID-19 confirmed by PCR

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Other
    Sofosbuvir / Daclatsvir

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

    Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg

Interventions

  • DrugSofosbuvir 400 MG/ Daclatasvir 60mg

    Giving these two drugs for treatment of COVID patients

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: it is estimated to be 2 weeks

07

Study locations

1 site
  • Amr Aly Abd elmoety
    Alexandria, 21521, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04773756
Lead sponsor
Alexandria University
Responsible party
Amr Aly Abd Elmoety (Professor, Internal Medicine Department, Alexandria University) — Principal investigator
First posted
Feb 26, 2021
Start date
Nov 1, 2020
Primary completion
Nov 30, 2020
Completion
Dec 12, 2020
Last update
Feb 26, 2021

Study contacts

Amr Abd elmoety, PhD
principal investigator · Alexandria University, Faculty of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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