Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04498377
Status:
TERMINATED
Last Update Posted:
2023-12-21
First Post:
2020-07-31
Brief Title:
Study of F-652 IL-22IgG2 Fusion Protein in Patients With Moderate to Severe COVID-19
Sponsor:
EVIVE Biotechnology
Organization:
EVIVE Biotechnology
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Dose-Escalation Multicenter Study to Evaluate the Efficacy and Safety of F-652 IL-22IgG2 Fusion Protein in Patients With Moderate to Severe COVID-19
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There have been significant changes in the FDA guidelines and clinical standard of care
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an interventional multicenter 2-arm parallel-group randomized double-blind placebo controlled dose-escalation safety and efficacy study of F-652 treatment versus placebo in patients aged 18 years or older with a COVID-19 diagnosis confirmed by PCR Eligible patients will have moderate to severe COVID-19 symptoms within 5 days post hospitalization and a positive COVID-19 testing
Detailed Description:
The study is planned to include 4 cohorts with enrolled patients being randomized 11 in a blinded manner on Day 1 following screening to F-652 or placebo as follows
Cohort 1 sentinel cohort Four patients will receive either dose level 1 F-652 or placebo Upon completion of sentinel the Data Monitoring Committee will evaluate the safety and tolerability data of the sentinel patients and determine if it is acceptable to dose the remaining patients in this dosing group in Cohort 2
Cohort 2 Fourteen patients will receive either dose level 1 F-652 or placebo Upon completion of Cohort 2 the DMC will convene and review all available safety data to determine if the study can proceed to the next dose level
Cohort 3 sentinel cohort Four patients will receive either dose level 2 F-652 or placebo Upon completion of sentinel dosing the DMC will evaluate the safety and tolerability data of the sentinel patients and determine if it is acceptable to dose the remaining patients in this dosing group in Cohort 4
Cohort 4 Sixteen patients will receive either dose level 2 F-652 or placebo Treatment will begin on Day 1 following randomization Patients assigned to active drug will receive a total of 2 doses of F-652 1 IV infusion on Day 1 and 1 IV infusion on Day 8 Patients assigned to placebo will receive identical IV infusions of placebo vehicle on Days 1 and 8 All patients will receive available supportive and antiviral therapies as standard of care Efficacy will be assessed on Days 15 and 29 Patients will be followed for safety until Day 60
The primary efficacy endpoint is the proportion of patients with a 2-point increase in the National Institute of Allergy and Infectious Diseases NIAID 8-point ordinal scale from baseline to Day 29
The secondary efficacy endpoints include the proportion of patients with a 2-point increase in the NIAID 8-point ordinal scale from baseline to Day 15 mortality rate by Days 15 and 29 percentage of patients who have recovered and discharged from the hospital by Days 15 and 29 and percentage of patients progressed to severecritical disease by Day 15
The safety endpoints include all cause treatment-emergent adverse events TEAEs and serious adverse events SAEs change from screening baseline in clinical symptoms and abnormal vital signs abnormal laboratory tests and relationship of any AEs with F-652 treatment
The exploratory endpoints include time to negative SARS-CoV-2 PCR test from randomization and changes in pharmacodynamic parameters
Cohort 1 sentinel cohort Four patients will receive either dose level 1 F-652 or placebo Upon completion of sentinel the Data Monitoring Committee will evaluate the safety and tolerability data of the sentinel patients and determine if it is acceptable to dose the remaining patients in this dosing group in Cohort 2
Cohort 2 Fourteen patients will receive either dose level 1 F-652 or placebo Upon completion of Cohort 2 the DMC will convene and review all available safety data to determine if the study can proceed to the next dose level
Cohort 3 sentinel cohort Four patients will receive either dose level 2 F-652 or placebo Upon completion of sentinel dosing the DMC will evaluate the safety and tolerability data of the sentinel patients and determine if it is acceptable to dose the remaining patients in this dosing group in Cohort 4
Cohort 4 Sixteen patients will receive either dose level 2 F-652 or placebo Treatment will begin on Day 1 following randomization Patients assigned to active drug will receive a total of 2 doses of F-652 1 IV infusion on Day 1 and 1 IV infusion on Day 8 Patients assigned to placebo will receive identical IV infusions of placebo vehicle on Days 1 and 8 All patients will receive available supportive and antiviral therapies as standard of care Efficacy will be assessed on Days 15 and 29 Patients will be followed for safety until Day 60
The primary efficacy endpoint is the proportion of patients with a 2-point increase in the National Institute of Allergy and Infectious Diseases NIAID 8-point ordinal scale from baseline to Day 29
The secondary efficacy endpoints include the proportion of patients with a 2-point increase in the NIAID 8-point ordinal scale from baseline to Day 15 mortality rate by Days 15 and 29 percentage of patients who have recovered and discharged from the hospital by Days 15 and 29 and percentage of patients progressed to severecritical disease by Day 15
The safety endpoints include all cause treatment-emergent adverse events TEAEs and serious adverse events SAEs change from screening baseline in clinical symptoms and abnormal vital signs abnormal laboratory tests and relationship of any AEs with F-652 treatment
The exploratory endpoints include time to negative SARS-CoV-2 PCR test from randomization and changes in pharmacodynamic parameters
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