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Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

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ClinicalTrials.gov Identifier: NCT04497649
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Tracking Information
First Submitted Date  ICMJE August 1, 2020
First Posted Date  ICMJE August 4, 2020
Last Update Posted Date December 3, 2020
Actual Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2020)
Number of patients with improvement or mortality [ Time Frame: 1 month ]
The number of patients with improvement or mortality
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 Containing Regimens in Treatment of COVID 19 Patients
Official Title  ICMJE Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial.
Brief Summary efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,
Detailed Description The study aims to assess Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Sofosbuvir
    Sofosbuvir once daily
    Other Name: Mpiviropack, Sovaldy, soflanork
  • Drug: Daclatasvir
    daclatasuvir once daily
    Other Name: daklinza, daklanork
Study Arms  ICMJE
  • Experimental: Sofosbuvir and Daklatasuvir
    Sofosbuvir and Daklatasuvir with standard of care treatment
    Interventions:
    • Drug: Sofosbuvir
    • Drug: Daclatasvir
  • No Intervention: Standard of care treatment
    Standard of care treatment
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: September 11, 2020)
100
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2020)
200
Estimated Study Completion Date  ICMJE April 10, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • COVID 19 positive patients

Exclusion Criteria:

  • COVID-19 patients with critical manifestations.
  • Sepsis.
  • Acute respiratory distress syndrome (ARDS).
  • Decompensated liver disease (Child-Pugh class B or C disease).
  • Chronic renal impairment.
  • Patients with blood diseases (severe anemia, thalassemia, ITP, leukemia ….).
  • Ischemic heart disease within the last 6 months.
  • Chronic pulmonary disease.
  • Malignancy.
  • Pregnancy or breastfeeding.
  • Hypersensitivity to sofosbuvir or ribavirin.
  • Patients with organ transplant.
  • Unwilling to participate in our study
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 NCT04497649
Other Study ID Numbers  ICMJE Tanta sofosbuvir covid
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, Lecturer Tanta University - Faculty of Medicine
Principal Investigator: sherief Abd-Elsalam, ass. Prof. Tanta University Faculty of medicine
Principal Investigator: Ahmed Cordie, lecturer Cairo University
Principal Investigator: Gamal Esmat, Professor Cairo University
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