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Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

Primary Purpose

Covid19

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Sofosbuvir

Daclatasvir

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

COVID 19 positive patients

Exclusion Criteria:

COVID-19 patients with critical manifestations.
Sepsis.
Acute respiratory distress syndrome (ARDS).
Decompensated liver disease (Child-Pugh class B or C disease).
Chronic renal impairment.
Patients with blood diseases (severe anemia, thalassemia, ITP, leukemia ….).
Ischemic heart disease within the last 6 months.
Chronic pulmonary disease.
Malignancy.
Pregnancy or breastfeeding.
Hypersensitivity to sofosbuvir or ribavirin.
Patients with organ transplant.
Unwilling to participate in our study

Sites / Locations

Cairo and Tanta UniversititiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sofosbuvir and Daklatasuvir

Standard of care treatment

Arm Description

Sofosbuvir and Daklatasuvir with standard of care treatment

Standard of care treatment

Outcomes

Primary Outcome Measures

Number of patients with improvement or mortality

The number of patients with improvement or mortality

Secondary Outcome Measures

Full Information

NCT ID

NCT04497649

First Posted

August 1, 2020

Last Updated

December 2, 2020

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT04497649

Brief Title

Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

Official Title

Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

April 1, 2021 (Anticipated)

Study Completion Date

April 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,

Detailed Description

The study aims to assess Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sofosbuvir and Daklatasuvir

Arm Type

Experimental

Arm Description

Sofosbuvir and Daklatasuvir with standard of care treatment

Arm Title

Standard of care treatment

Arm Type

No Intervention

Arm Description

Standard of care treatment

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir

Other Intervention Name(s)

Mpiviropack, Sovaldy, soflanork

Intervention Description

Sofosbuvir once daily

Intervention Type

Drug

Intervention Name(s)

Daclatasvir

Other Intervention Name(s)

daklinza, daklanork

Intervention Description

daclatasuvir once daily

Primary Outcome Measure Information:

Title

Number of patients with improvement or mortality

Description

The number of patients with improvement or mortality

Time Frame

1 month

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: COVID 19 positive patients Exclusion Criteria: COVID-19 patients with critical manifestations. Sepsis. Acute respiratory distress syndrome (ARDS). Decompensated liver disease (Child-Pugh class B or C disease). Chronic renal impairment. Patients with blood diseases (severe anemia, thalassemia, ITP, leukemia ….). Ischemic heart disease within the last 6 months. Chronic pulmonary disease. Malignancy. Pregnancy or breastfeeding. Hypersensitivity to sofosbuvir or ribavirin. Patients with organ transplant. Unwilling to participate in our study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sherief Abd-Elsalam, ass. prof.

Phone

00201147773440

sheriefabdelsalam@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

sherief abd-elsalan, ass. prof.

Phone

00201147773440

sheriefabdelsalam@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marwa Salama, Lecturer

Organizational Affiliation

Tanta University - Faculty of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

sherief Abd-Elsalam, ass. Prof.

Organizational Affiliation

Tanta University Faculty of medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ahmed Cordie, lecturer

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gamal Esmat, Professor

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cairo and Tanta Universitities

City

Tanta

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

sherief abd-elsalam, ass. prof

Phone

00201147773440

sheriefabdelsalam@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

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