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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

Study Description
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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
Study Design
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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

Arms and Interventions
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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


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


Eligibility Criteria
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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.
Contacts and Locations
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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
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Contact: Sherief Abd-Elsalam, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com
Contact: sherief abd-elsalan, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-Elsalam, Ass. Prof.    00201009221243    sheriefabdelsalam@yahoo.com   
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Marwa Salama, Consultant Tanta University - Faculty of Medicine
More Information
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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

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