COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04860518

Daniel Talmor and Adit Ginde

Not reported

2021-04-27

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: age ≥18 years positive sars-cov-2 test by pcr (polymerase chain reaction) or other diagnostic method within the past 7 days admission to hospital with respiratory symptoms of covid-19 requiring hospital care and oxygen supplementation (≤ 8l/min) respiratory symptom onset no more than 7 days prior to hospital arrival informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available

unable to screen, randomize and administer study drug within 48 hours from arrival to hospital systemic corticosteroid, baricitinib or tofacitinib (or other jak-stat signalling pathway inhibitors) therapy within 7 days prior to arrival to hospital or planned for the next days known hypersensitivity or contraindication to natural or recombinant ifn-beta-1a or its excipients, or to dexamethasone or its excipients currently receiving ifn-beta-1a therapy home assisted ventilation (via tracheotomy or non-invasive) except for continuous positive airway pressure (cpap) / bilevel positive airway pressure (bipap) used only for sleep-disordered breathing participation in another concurrent interventional pharmacotherapy trial during the study period decision to withhold life-sustaining treatment; patient not committed to full support (except dnr after cardiac arrest only) woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test) subject is not expected to survive for 24 hours subject has liver failure (child-pugh grade c) any clinical condition that in the opinion of the attending clinician or investigator would present a risk for the subject to participate in the study

2

Faron Pharmaceuticals Ltd

18

100

United States

Moderate disease at enrollment

3: Moderate disease at enrollment

7

Clinical status at Day 14 (first day of study drug is Day 1) as measured by WHO 9-point ordinal scale

None

Phase 2

[{"arm_notes": "", "treatment_id": 671, "treatment_name": "Interferon beta 1a", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]