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

• Sponsor: Alexandria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04773756
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 40.1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg	Phase 4

Study Design

• Study Type: Interventional
• 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: Nov 1, 2020
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Dec 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
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; Giving these two drugs for treatment of COVID patients

Outcome Measures

Primary Outcome Measures

1. evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19. [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amr Aly Abd elmoety	Alexandria		Egypt	21521

Sponsors and Collaborators

• Alexandria University

Investigators

• Principal Investigator: Amr Abd elmoety, PhD, Alexandria University, Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amr Aly Abd Elmoety, Professor, Internal Medicine Department, Alexandria University
• ClinicalTrials.gov Identifier: NCT04773756
• Other Study ID Numbers: 0305032
• First Posted: Feb 26, 2021
• Last Update Posted: Feb 26, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Amr Aly Abd Elmoety, Professor, Internal Medicine Department, Alexandria University: Sofosbuvir; Daclatasvir
• Additional relevant MeSH terms: Sofosbuvir

Study Results

No Results Posted as of Feb 26, 2021