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Sofosbuvir in Treatment of COVID 19

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04460443
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
13
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sofosbuvir containing treatment in treatment of COVID 19 Egyptian patients

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

Detailed Description

Sofosbuvir containing treatment of COVID 19 Egyptian patients: a randomized-controlled trial

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sofosbuvir Based Regimens in Treatment of COVID 19 Patients
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sofosbuvir and ledipsavir

Sofosbuvir and ledipsavir plus standard of care treatment.

Drug: Sofosbuvir ledipsavir
Sofosbuvir ledipsavir once daily
Other Names:
  • mpiviropack plus

    		•
    Experimental: Sofosbuvir and Daklatasuvir

    Sofosbuvir and Daklatasuvir plus standard of card treatment..

    Drug: sofosbuvir
    Sofosbuvir once daily
    Other Names:
  • Mpiviropack, Sovaldy, soflanork

    • Drug: Daclatasvir
    Daklatasuvir tablets
    Other Names:
  • daklinza

    		•
    No Intervention: Standard treatment

    Standard treatment alone

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with response to treatment [1 month]

      The total number of patients with response to treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Covid positive patients.
    Exclusion Criteria:
    • Contraindication to sofosbuvir or ribavirin.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sherief Abd-Elsalam Tanta Egypt

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: Marwa Salama, Consultant, 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:
    NCT04460443
    Other Study ID Numbers:
    • sofosbuvir
    First Posted:
    Jul 7, 2020
    Last Update Posted:
    Dec 8, 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:
    Sofosbuvir

    Study Results

    No Results Posted as of Dec 8, 2020