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Sofosbuvir in Treatment of COVID 19

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ClinicalTrials.gov Identifier: NCT04460443
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Tracking Information
First Submitted Date  ICMJE July 4, 2020
First Posted Date  ICMJE July 7, 2020
Last Update Posted Date December 8, 2020
Actual Study Start Date  ICMJE August 1, 2020
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2020)
Number of patients with response to treatment [ Time Frame: 1 month ]
The total number of patients with response to treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sofosbuvir in Treatment of COVID 19
Official Title  ICMJE Sofosbuvir Based Regimens in Treatment of COVID 19 Patients
Brief Summary Sofosbuvir containing treatment in treatment of COVID 19 Egyptian patients
Detailed Description Sofosbuvir containing treatment of COVID 19 Egyptian patients: a randomized-controlled trial
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID
Intervention  ICMJE
  • Drug: sofosbuvir
    Sofosbuvir once daily
    Other Name: Mpiviropack, Sovaldy, soflanork
  • Drug: Sofosbuvir ledipsavir
    Sofosbuvir ledipsavir once daily
    Other Name: mpiviropack plus
  • Drug: Daclatasvir
    Daklatasuvir tablets
    Other Name: daklinza
Study Arms  ICMJE
  • Experimental: Sofosbuvir and ledipsavir
    Sofosbuvir and ledipsavir plus standard of care treatment.
    Intervention: Drug: Sofosbuvir ledipsavir
  • Experimental: Sofosbuvir and Daklatasuvir
    Sofosbuvir and Daklatasuvir plus standard of card treatment..
    Interventions:
    • Drug: sofosbuvir
    • Drug: Daclatasvir
  • No Intervention: Standard treatment
    Standard treatment alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Covid positive patients.

Exclusion Criteria:

  • Contraindication to sofosbuvir or ribavirin.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sherief Abd-Elsalam, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com
Contact: sherief abd-elsalan, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04460443
Other Study ID Numbers  ICMJE sofosbuvir
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sherief Abd-Elsalam, Tanta University
Study Sponsor  ICMJE Tanta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marwa Salama, Consultant Tanta University - Faculty of Medicine
PRS Account Tanta University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP