Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

NCT04497649 — Phase 2 / Phase 3, Unknown, 100 participants, Tanta University

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Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial.

Registry	NCT04497649
Status	Unknown
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	100 (Estimated)
Sponsor	Tanta University (Other)
Conditions	Covid19
Interventions	Sofosbuvir, Daclatasvir (Drug)
Dates	start 2020-07-01, primary completion 2021-04-01 (estimated), completion 2021-04-10 (estimated), first posted 2020-08-04, last updated 2020-12-03
Locations	1 site in Egypt

-Summary

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

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
Sofosbuvir and Daklatasuvir	Experimental	Drug: Sofosbuvir; Drug: Daclatasvir	Sofosbuvir and Daklatasuvir with standard of care treatment
Standard of care treatment	No intervention		Standard of care treatment

Sofosbuvir (Drug), also known as Mpiviropack, Sovaldy, soflanork: Sofosbuvir once daily
Daclatasvir (Drug), also known as daklinza, daklanork: daclatasuvir once daily

+Outcome measures

Primary outcomes

Number of patients with improvement or mortality [1 month]: The number of patients with improvement or mortality

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
Cairo and Tanta Universitities	Tanta	Egypt	Recruiting

+Investigators

Marwa Salama, Lecturer, Principal investigator, Tanta University - Faculty of Medicine
sherief Abd-Elsalam, ass. Prof., Principal investigator, Tanta University Faculty of medicine
Ahmed Cordie, lecturer, Principal investigator, Cairo University
Gamal Esmat, Professor, Principal investigator, Cairo University