Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients
1 other identifier
interventional
100
1 country
1
Brief Summary
efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 1, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2021
CompletedDecember 3, 2020
December 1, 2020
9 months
August 1, 2020
December 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with improvement or mortality
The number of patients with improvement or mortality
1 month
Study Arms (2)
Sofosbuvir and Daklatasuvir
EXPERIMENTALSofosbuvir and Daklatasuvir with standard of care treatment
Standard of care treatment
NO INTERVENTIONStandard of care treatment
Interventions
Sofosbuvir once daily
Eligibility Criteria
You may qualify if:
- COVID 19 positive patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Cairo and Tanta Universitities
Tanta, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass. Prof. Tropical Medicine
Study Record Dates
First Submitted
August 1, 2020
First Posted
August 4, 2020
Study Start
July 1, 2020
Primary Completion
April 1, 2021
Study Completion
April 10, 2021
Last Updated
December 3, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share