Ignite Creation Date:
2024-05-06 @ 4:22 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04960202
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2021-07-10
Brief Title:
EPIC-HR Study of Oral PF-07321332Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
AN INTERVENTIONAL EFFICACY AND SAFETY PHASE 23 DOUBLE-BLIND 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS
Status:
COMPLETED
Status Verified Date:
2023-01
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 purpose of this study is to determine whether PF-07321332ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital but are at an increased risk of developing severe illness Throughout the study period provision will be made to allow study visits to be conducted at a participants home or another non-clinic location if available The total study duration is up to 24 weeks
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EPIC-HR | OTHER | Alias Study Number | None |
| 2021-002895-38 | EUDRACT_NUMBER | None | None |