Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04539262
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2020-08-26
Brief Title:
Study in Participants With Early Stage Coronavirus Disease 2019 COVID-19 to Evaluate the Safety Efficacy and Pharmacokinetics of Remdesivir Administered by Inhalation
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 1b2a Study in Participants With Early Stage COVID-19 to Evaluate the Safety Efficacy and Pharmacokinetics of Remdesivir Administered by Inhalation
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to characterize the impact of inhaled remdesivir RDV on severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 viral load in participants with early stage coronavirus disease 2019 COVID-19
Detailed Description:
This study will have multiple parts Part A Part B and Part C Part B will be conducted if supported by evaluation in healthy volunteers in another Phase 1a Gilead study GS-US-553-9018 Participants in Part C will be enrolled after review of preliminary safety and available efficacy data from Parts A and B through at least Day 7
GS-US-553-9018 is a Phase 1a randomized blinded placebo-controlled single- and multiple-dose study in healthy volunteers to evaluate the safety tolerability and pharmacokinetics of remdesivir administered by inhalation
GS-US-553-9018 is a Phase 1a randomized blinded placebo-controlled single- and multiple-dose study in healthy volunteers to evaluate the safety tolerability and pharmacokinetics of remdesivir administered by inhalation
Study Oversight
Has Oversight DMC:
None
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?:
None