- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04345419
Remdesivir Efficacy in Coronavirus Disease
July 29, 2021 updated by: Sherief Abd-Elsalam, Tanta University
Remdesivir in COVID-19 Treatment: A Randomised Trial
COVID 19 treatment using Remedesvir.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
COVID 19 treatment using Remedesvir.
Is this drug effective?
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tanta, Egypt
- Tanta university hospital, Assuit University, Ainshams University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- COVID 19 patients
Exclusion Criteria:
- allergy or contraindication to the drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Remdesivir
Remdesivir with standard of care treatment standard of care treatment
|
Remdesivir as antiviral drug
Standard of care treatment
|
Placebo Comparator: Standard of care
Standard of care treatment alone.
|
Standard of care treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with improvement or mortality
Time Frame: 6 months
|
the estimated number of patients with improvement or mortality
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sherief Abd-Elsalam, ass. prof., Tanta University Faculty of medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 16, 2020
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
April 11, 2020
First Submitted That Met QC Criteria
April 13, 2020
First Posted (Actual)
April 14, 2020
Study Record Updates
Last Update Posted (Actual)
August 2, 2021
Last Update Submitted That Met QC Criteria
July 29, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID 19 treatment
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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