Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sofosbuvir in Treatment of COVID 19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Brief Summary:
Sofosbuvir containing treatment in treatment of COVID 19 Egyptian patients

Condition or disease Intervention/treatment Phase
COVID Drug: sofosbuvir Drug: Sofosbuvir ledipsavir Drug: Daclatasvir Phase 2 Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 1, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Sofosbuvir and ledipsavir
Sofosbuvir and ledipsavir plus standard of care treatment.
Drug: Sofosbuvir ledipsavir
Sofosbuvir ledipsavir once daily
Other Name: mpiviropack plus

Experimental: Sofosbuvir and Daklatasuvir
Sofosbuvir and Daklatasuvir plus standard of card treatment..
Drug: sofosbuvir
Sofosbuvir once daily
Other Name: Mpiviropack, Sovaldy, soflanork

Drug: Daclatasvir
Daklatasuvir tablets
Other Name: daklinza

No Intervention: Standard treatment
Standard treatment alone



Primary Outcome Measures :
  1. Number of patients with response to treatment [ Time Frame: 1 month ]
    The total number of patients with response to treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Covid positive patients.

Exclusion Criteria:

  • Contraindication to sofosbuvir or ribavirin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460443


Contacts
Layout table for location contacts
Contact: Sherief Abd-Elsalam, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com
Contact: sherief abd-elsalan, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com

Locations
Layout table for location information
Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-Elsalam, Ass. Prof.    00201009221243    sheriefabdelsalam@yahoo.com   
Sponsors and Collaborators
Tanta University
Investigators
Layout table for investigator information
Principal Investigator: Marwa Salama, Consultant Tanta University - Faculty of Medicine
Layout table for additonal information
Responsible Party: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT04460443    
Other Study ID Numbers: sofosbuvir
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sofosbuvir
Antiviral Agents
Anti-Infective Agents