Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04498377|
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : January 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Biological: F-652 Biological: Placebo||Phase 2|
The study is planned to include 4 cohorts, with enrolled patients being randomized 1:1 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 severe/critical 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
Patients will be randomized in a 1:1 ratio in a double-blind manner to receive F-652 or placebo.
An independent statistician from Medpace will generate the randomization schedule. Patients meeting eligibility criteria will be randomized on Day 1 in a 1:1 ratio to F-652 or placebo, respectively. Patients will be assigned a randomization number and treatment assignment according to the randomization schedule. This randomization schedule will be maintained by the investigative site pharmacist until it is appropriate to break the blind. The Investigator, investigative site personnel (except site-designated pharmacist and dedicated assistant), study monitors, vendors, Sponsor, and Medpace will remain blinded to treatment assignment.
|Official Title:||A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Multicenter Study to Evaluate the Efficacy and Safety of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19|
|Actual Study Start Date :||January 26, 2021|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
IL-22 fusion protein administered intravenously
|Placebo Comparator: Placebo||
Placebo administered intravenously
- NIAID 8-point ordinal scale [ Time Frame: Study day 1 before dose to day 29 ]The proportion of patients with a greater or equal 2-point change in the NIAID 8-point ordinal scale from baseline to Day 29
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498377
|Contact: William L Daley, MDfirstname.lastname@example.org|
|United States, Louisiana|
|Tulane University School of Medicine||Recruiting|
|New Orleans, Louisiana, United States, 70112|
|Contact: Cynthia Moreau, RN email@example.com|
|Principal Investigator: Christine Bojanowski, MD|
|Principal Investigator:||Christine M Bojanowski, MD||Tulane University|