Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Sofosbuvir
Daclatasvir
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility 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
Sites / Locations
- Cairo and Tanta UniversititiesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sofosbuvir and Daklatasuvir
Standard of care treatment
Arm Description
Sofosbuvir and Daklatasuvir with standard of care treatment
Standard of care treatment
Outcomes
Primary Outcome Measures
Number of patients with improvement or mortality
The number of patients with improvement or mortality
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04497649
Brief Title
Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients
Official Title
Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
April 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sofosbuvir and Daklatasuvir
Arm Type
Experimental
Arm Description
Sofosbuvir and Daklatasuvir with standard of care treatment
Arm Title
Standard of care treatment
Arm Type
No Intervention
Arm Description
Standard of care treatment
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
Mpiviropack, Sovaldy, soflanork
Intervention Description
Sofosbuvir once daily
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Other Intervention Name(s)
daklinza, daklanork
Intervention Description
daclatasuvir once daily
Primary Outcome Measure Information:
Title
Number of patients with improvement or mortality
Description
The number of patients with improvement or mortality
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
sherief abd-elsalan, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa Salama, Lecturer
Organizational Affiliation
Tanta University - Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
sherief Abd-Elsalam, ass. Prof.
Organizational Affiliation
Tanta University Faculty of medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Cordie, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gamal Esmat, Professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo and Tanta Universitities
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sherief abd-elsalam, ass. prof
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients
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