Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT04745351
Status:
TERMINATED
Last Update Posted:
2023-05-12
First Post:
2021-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
Sponsor:
Gilead Sciences
Organization:
Study Overview
Official Title:
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to study enrollment feasibility. This decision is not based on efficacy or safety concerns.
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04323761
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
REDPINE
Brief Summary:
The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: