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.
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.
Biological: F-652
IL-22 fusion protein administered intravenously
Biological: Placebo
Placebo administered intravenously
Inclusion Criteria:
- 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 Criteria:
- 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
Tulane University School of Medicine
New Orleans, Louisiana, United States
Christine M Bojanowski, MD, Principal Investigator
Tulane University