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Efficacy of Faviprevir in COVID-19 Treatment

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT04351295
Collaborator
(none)
92
Enrollment
1
Location
2
Arms
5.3
Actual Duration (Months)
17.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Faviprevir in COVID-19 treatment

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

Detailed Description

Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 treatment

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 Treatment
Actual Study Start Date :
Apr 20, 2020
Actual Primary Completion Date :
Sep 28, 2020
Actual Study Completion Date :
Sep 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Faviprevir

Faviprevir

Drug: Favipiravir
Favipiravir
Other Names:
  • Faviprevir

    		•
    Active Comparator: chloroquine

    chloroquine

    Drug: Chloroquine
    chloroquine oral tablets

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with mortality or need for mechanical ventilation [6 months]

      Number of patients with mortality or need for mechanical ventilation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with covid 19
    Exclusion Criteria:
    • Allergy or contraindications to faviprevir

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University, Ainshams University Tanta Egypt 35111

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: sherief Abd-Elsalam, Ass. Prof., Tanta University - Faculty of Medicine

    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:
    NCT04351295
    Other Study ID Numbers:
    • faviprevir covid
    First Posted:
    Apr 17, 2020
    Last Update Posted:
    Nov 1, 2021
    Last Verified:
    Oct 1, 2021
    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:
    Chloroquine
    Favipiravir

    Study Results

    No Results Posted as of Nov 1, 2021