Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

NCT ID: NCT04497649

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-04-10

Brief Summary

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

Detailed Description

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

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sofosbuvir and Daklatasuvir

Sofosbuvir and Daklatasuvir with standard of care treatment

Group Type EXPERIMENTAL

Sofosbuvir

Intervention Type DRUG

Sofosbuvir once daily

Daclatasvir

Intervention Type DRUG

daclatasuvir once daily

Standard of care treatment

Standard of care treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sofosbuvir

Sofosbuvir once daily

Intervention Type DRUG

Daclatasvir

daclatasuvir once daily

Intervention Type DRUG

Other Intervention Names

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Mpiviropack, Sovaldy, soflanork daklinza, daklanork

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Ass. Prof. Tropical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwa Salama, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Tanta University - Faculty of Medicine

sherief Abd-Elsalam, ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Tanta University Faculty of medicine

Ahmed Cordie, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Gamal Esmat, Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo and Tanta Universitities

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, ass. prof.

Role: CONTACT

Phone: 00201147773440

Email: [email protected]

sherief abd-elsalan, ass. prof.

Role: CONTACT

Phone: 00201147773440

Email: [email protected]

Facility Contacts

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sherief abd-elsalam, ass. prof

Role: primary

Other Identifiers

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Tanta sofosbuvir covid

Identifier Type: -

Identifier Source: org_study_id