NCT04345419

Brief Summary

COVID 19 treatment using Remedesvir.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

April 11, 2020

Last Update Submit

July 29, 2021

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

  • Number of patients with improvement or mortality

    the estimated number of patients with improvement or mortality

    6 months

Study Arms (2)

Remdesivir

EXPERIMENTAL

Remdesivir with standard of care treatment standard of care treatment

Drug: RemdesivirOther: Standard of care treatment

Standard of care

PLACEBO COMPARATOR

Standard of care treatment alone.

Other: Standard of care treatment

Interventions

RemdesivirDRUG

Remdesivir as antiviral drug

Remdesivir
Standard of care treatmentOTHER

Standard of care treatment

RemdesivirStandard of care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • COVID 19 patients

You may not qualify if:

  • allergy or contraindication to the drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university hospital, Assuit University, Ainshams University

Tanta, Egypt

Location

Related Publications (1)

  • Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.

    PMID: 36695483DERIVED

MeSH Terms

Interventions

remdesivir

Study Officials

  • Sherief Abd-Elsalam, ass. prof.

    Tanta University Faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of tropical medicine and infectious diseases

Study Record Dates

First Submitted

April 11, 2020

First Posted

April 14, 2020

Study Start

June 16, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)