Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt
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ClinicalTrials.gov Identifier: NCT04773756 |
Recruitment Status :
Completed
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
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Condition or disease | Intervention/treatment | Phase |
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Covid19 | Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt (Single Center Study) |
Actual Study Start Date : | November 1, 2020 |
Actual Primary Completion Date : | November 30, 2020 |
Actual Study Completion Date : | December 12, 2020 |

Arm | Intervention/treatment |
---|---|
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
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Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg
Giving these two drugs for treatment of COVID patients |
- evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19. [ Time Frame: it is estimated to be 2 weeks ]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

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Ages Eligible for Study: | 12 Years to 90 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- mild- moderate COVID-19 confirmed by PCR
Exclusion Criteria:
- Patients on renal dialysis
- Severe COVID-19 cases
- Patients on amiodarone therapy (given the reported FDA warning of an interaction between amiodarone and sofosbuvir that might lead to severe bradycardia).
- Children < 12 years
- Pregnant and breast feeding women
- Exacerbation of hepatitis B

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04773756
Egypt | |
Amr Aly Abd elmoety | |
Alexandria, Egypt, 21521 |
Principal Investigator: | Amr Abd elmoety, PhD | Alexandria University, Faculty of Medicine |
Responsible Party: | Amr Aly Abd Elmoety, Professor, Internal Medicine Department, Alexandria University |
ClinicalTrials.gov Identifier: | NCT04773756 |
Other Study ID Numbers: |
0305032 |
First Posted: | February 26, 2021 Key Record Dates |
Last Update Posted: | February 26, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Sofosbuvir Daclatasvir |
Sofosbuvir Antiviral Agents Anti-Infective Agents |