Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19

NCT04498377 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: GC-652-04
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• NIAID 8-point Ordinal Scale

  The proportion of patients with a greater or equal 2-point change in the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale from baseline to Day 29. The NIAID 8-point ordinal scale includes the following grades: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplementation oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized, limitation on activities and/or requiring home oxygen; and 8. Not hospitalized, no limitations on activities.

  Study day 1 before dose to day 29

Study Arms (2)

F-652

EXPERIMENTAL

Patient receives standard care plus F-652

Biological: F-652

Placebo

PLACEBO COMPARATOR

Patient receives standard care plus placebo

Biological: Placebo

Interventions

F-652 BIOLOGICAL

IL-22 fusion protein administered intravenously

F-652

Placebo BIOLOGICAL

Placebo administered intravenously

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to provide informed consent and able to comply with protocol requirements
• years or older
• Has a COVID-19 diagnosis confirmed by PCR
• Hospitalized within 5 days and meets the following criteria at screening:
• Peripheral capillary oxygen saturation (SpO2) ≤ 93% on room air or SpO2 ≥93% on ≤10 liters per minute of supplemental oxygen via nasal cannula
• Radiographic (chest X-ray, computed tomography scan, or ultrasound) evidence of bilateral pulmonary infiltrates consistent with SARS-CoV-2/COVID-19
• Clinical symptoms consistent with COVID-19 per Investigator judgement
• Body mass index between 18 to 40 kg/m2
• If of reproductive potential, willing to abstain or agree to the use of highly effective contraception

You may not qualify if:

• Respiratory failure at screening
• History of heart failure
• History of COPD or bronchial asthma
• Active TB or history of TB of the following types
• Uncontrolled arrhythmia within 3 months prior to randomization
• Heart disease of the following types
• Moderate to severe renal insufficiency
• Abnormal white cell and platelet counts
• History of transplantation of vital organs (e.g., heart, lung, liver, and/or kidney);
• Malignant tumor
• Uncontrolled systemic or local autoimmune or inflammatory disease besides SARS-CoV-2
• Unhealed wounds, active gastric ulcer, had surgery
• Received other investigational therapeutic products
• Used interferon therapies
• History of HIV infection, hepatitis B, and/or hepatitis C

Sponsors & Collaborators

• EVIVE Biotechnology: lead

Study Sites (1)

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

eflepedocokin alfa

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Jianmin Chen
• Organization: Evive Biotech

jianmin.chen@evivebiotech.com

6095124566

Study Officials

• Christine M Bojanowski, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 4, 2020
• Study Start: January 26, 2021
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: December 21, 2023
• Results First Posted: December 21, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)