Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04497649
Collaborator
(none)
100
1
2
9.3
10.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial.
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Apr 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sofosbuvir and Daklatasuvir

Sofosbuvir and Daklatasuvir with standard of care treatment

Drug: Sofosbuvir
Sofosbuvir once daily
Other Names:
  • Mpiviropack, Sovaldy, soflanork
  • Drug: Daclatasvir
    daclatasuvir once daily
    Other Names:
  • daklinza, daklanork
  • No Intervention: Standard of care treatment

    Standard of care treatment

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with improvement or mortality [1 month]

      The number of patients with improvement or mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo and Tanta Universitities Tanta Egypt

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: Marwa Salama, Lecturer, Tanta University - Faculty of Medicine
    • Principal Investigator: sherief Abd-Elsalam, ass. Prof., Tanta University Faculty of medicine
    • Principal Investigator: Ahmed Cordie, lecturer, Cairo University
    • Principal Investigator: Gamal Esmat, Professor, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04497649
    Other Study ID Numbers:
    • Tanta sofosbuvir covid
    First Posted:
    Aug 4, 2020
    Last Update Posted:
    Dec 3, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2020