Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Remdesivir Efficacy in Coronavirus Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345419
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
COVID 19 treatment using Remedesvir.

Condition or disease Intervention/treatment Phase
COVID Drug: Remdesivir Other: Standard of care treatment Phase 2 Phase 3

Detailed Description:
COVID 19 treatment using Remedesvir. Is this drug effective?
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Remdesivir in COVID-19 Treatment: A Randomised Trial
Actual Study Start Date : June 16, 2020
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Remdesivir
Remdesivir with standard of care treatment standard of care treatment
 Drug: Remdesivir
Remdesivir as antiviral drug

Other: Standard of care treatment
Standard of care treatment
Placebo Comparator: Standard of care
Standard of care treatment alone.
 Other: Standard of care treatment
Standard of care treatment


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of patients with improvement or mortality [ Time Frame: 6 months ]
    the estimated number of patients with improvement or mortality


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COVID 19 patients

Exclusion Criteria:

  • allergy or contraindication to the drug
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345419


Locations
Layout table for location information
Egypt
Tanta university hospital, Assuit University, Ainshams University
Tanta, Egypt
Sponsors and Collaborators
Tanta University
Investigators
Layout table for investigator information
Principal Investigator: Sherief Abd-Elsalam, ass. prof. Tanta University Faculty of medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sherief Abd-Elsalam, assistant professor of tropical medicine and infectious diseases, Tanta University
ClinicalTrials.gov Identifier: NCT04345419    
Other Study ID Numbers: COVID 19 treatment
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Remdesivir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents