COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04343976

Raymond Chung

JLGustafson@mgh.harvard.edu

2020-04-14

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - able to provide informed consent - confirmed covid-19 diagnosis based on pcr analysis of respiratory secretions - positive sars-cov-2 rt-pcr test must be within 48 hours of randomization

- clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol - treatment with ifn or other immunomodulatory/immunosuppressive agent within 12 months before screening. - respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation) - history of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-il-6, anti-il6r antagonists, janus kinase inhibitors, ustekinumab (anti-il-12/23), or anti il-23 agents (guselkumab). - life threatening sae during the screening period - pregnant or nursing females - platelet count <90,000 cells/mm3 - wbc count <3,000 cells/mm3 - anc <1,500 cells/mm3 - hb <11 g/dl for women and <12 g/dl for men - crcl < 50 ml/min - bilirubin level ≥ 1.5x uln - inr ≥1.5 (except in the setting of concomitant anticoagulant use) - crp > 200 mg/l - clinically-relevant alcohol or drug abuse within 12 months of screening - known hypersensitivity to interferons - current or planned participation in an investigational new drug (ind) trial from 30-days prior to randomization through day 14 post treatment

2

Raymond Chung

18

None

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

14

Undetectable COVID PCR at day 7

None

Phase 2

[{"arm_notes": "", "treatment_id": 674, "treatment_name": "Interferon lambda", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]