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Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

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: 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

Brief Summary:
efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,

Condition or disease Intervention/treatment Phase
Covid19 Drug: Sofosbuvir Drug: Daclatasvir Phase 2 Phase 3

Detailed Description:
The study aims to assess Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial.
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sofosbuvir and Daklatasuvir
Sofosbuvir and Daklatasuvir with standard of care treatment
Drug: Sofosbuvir
Sofosbuvir once daily
Other Name: Mpiviropack, Sovaldy, soflanork

Drug: Daclatasvir
daclatasuvir once daily
Other Name: daklinza, daklanork

No Intervention: Standard of care treatment
Standard of care treatment



Primary Outcome Measures :
  1. Number of patients with improvement or mortality [ Time Frame: 1 month ]
    The number of patients with improvement or mortality



Information from the National Library of Medicine

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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 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

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): NCT04497649


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
Cairo and Tanta Universitities Recruiting
Tanta, Egypt
Contact: sherief abd-elsalam, ass. prof    00201147773440    sheriefabdelsalam@yahoo.com   
Sponsors and Collaborators
Tanta University
Investigators
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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
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Responsible Party: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT04497649    
Other Study ID Numbers: Tanta sofosbuvir covid
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: December 3, 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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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Sofosbuvir
Antiviral Agents
Anti-Infective Agents