Status:
TERMINATED
Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19
Lead Sponsor:
EVIVE Biotechnology
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ag...
Detailed Description
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):...
Eligibility Criteria
Inclusion
- Willing to provide informed consent and able to comply with protocol requirements
- 18 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
Exclusion
- 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
- Known serious allergic reaction or hypersensitivity to components of F-652
- Pregnant or breastfeeding
- History of drug abuse or use of narcotics
- Treated with immunomodulators or immunosuppressants
- Other conditions resulting in increased risk
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04498377
Start Date
January 26 2021
End Date
March 24 2021
Last Update
December 21 2023
Active Locations (1)
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1
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112