COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04498377

Christine M Bojanowski, MD

William L Daley, william.daley@evivebiotech.com (PI email not reported)

2020-08-04

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

- 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

2

EVIVE Biotechnology

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

1

NIAID 8-point ordinal scale

None

Phase 2

[{"arm_notes": "", "treatment_id": 677, "treatment_name": "Interleukin-22", "treatment_type": "Interleukins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]