Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-27 @ 11:10 AM
Study NCT ID:
NCT05205668
Status:
WITHDRAWN
Last Update Posted:
2023-10-02
First Post:
2022-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of F-652 in Subjects With Corona Virus Disease 2019 (COVID-19) Pneumonia
Sponsor:
EVIVE Biotechnology
Organization:
Study Overview
Official Title:
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of F-652 in Subjects With COVID-19 Pneumonia
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Compound development plan changed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 2a, multicenter, randomized, double-blinded, placebo controlled, dose escalation study in adult subjects with COVID-19 pneumonia. The primary objective of this study is to evaluate the overall safety of F-652 in COVID subjects in order to identify safe dose(s) for future studies with adequate patient numbers to demonstrate clinical efficacy.
Detailed Description:
The study is planned to include 2 cohorts, with enrolled patients being randomized 2:1 in a blinded manner on Day 1, following screening, to F-652 or placebo as follows:
* Cohort 1: subjects will receive up to two intravenous (IV) infusions of F-652 at dose 1 or placebo. Upon completion of Cohort 1, the data monitoring committee (DMC) will convene and review all available safety data to determine if the study can proceed to the next dose level.
* Cohort 2: subjects will receive up to two IV infusions of F-652 at dose 2 or placebo.
Approximately 60 eligible subjects will be enrolled in the study with 30 subjects per dose cohort. Each cohort will have about 20 subjects treated with F-652 and 10 subjects treated with matching placebo.
All randomized subjects will receive standard-of-care treatments for COVID-19 per individual institution standards. Treatment will begin on Day 1 following randomization. Subjects will receive up to two IV infusions of F-652 or matching placebo.
* Cohort 1: subjects will receive up to two intravenous (IV) infusions of F-652 at dose 1 or placebo. Upon completion of Cohort 1, the data monitoring committee (DMC) will convene and review all available safety data to determine if the study can proceed to the next dose level.
* Cohort 2: subjects will receive up to two IV infusions of F-652 at dose 2 or placebo.
Approximately 60 eligible subjects will be enrolled in the study with 30 subjects per dose cohort. Each cohort will have about 20 subjects treated with F-652 and 10 subjects treated with matching placebo.
All randomized subjects will receive standard-of-care treatments for COVID-19 per individual institution standards. Treatment will begin on Day 1 following randomization. Subjects will receive up to two IV infusions of F-652 or matching placebo.
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?: