Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: F-652; Placebo
Intervention description: IL-22 fusion protein administered intravenously; Placebo administered intravenously
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: 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.
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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