COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04331899

Upinder Singh

Not reported

2020-04-02

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: age ≥ 18 years and ≤ 75 years at the time of the assessment able and willing to understand the study, adhere to all study procedures, and provide written informed consent diagnosis of covid-19 disease: if symptomatic, the presence of mild to moderate symptoms without signs of respiratory distress, with fda-cleared molecular diagnostic assay positive for sars-cov-2 within 72 hours from swab to the time of commencing informed consent: if asymptomatic, initial diagnosis of sars-cov-2 infection with positive fda-cleared molecular diagnostic assay obtained no more than 72 hours from initial swab to the time of commencing informed consent

patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent patients with a known allergy to peginterferon lambda-1a or any component thereof display symptoms of respiratory distress (respiratory rate >20, room air oxygen saturation of <94%.) participation in a clinical trial with or use of any investigational agent within 30 days before screening treatment with interferons (ifn) within 12 months before screening previous use of peginterferon lambda-1a history or evidence of any intolerance or hypersensitivity to ifns or other substances contained in the study medication. female patients who are pregnant or breastfeeding. male patients must confirm that their female sexual partners are not pregnant. current or previous history of decompensated liver disease (child-pugh class b or c) or hepatocellular carcinoma co-infected with human immunodeficiency virus (hiv) significant abnormal laboratory test results at screening. other significant medical condition that may require intervention during the study concurrent use of any of the following medications: therapy with an immunomodulatory agent current use of heparin or coumadin received blood products within 30 days before study randomization use of hematologic growth factors within 30 days before study randomization systemic antibiotics, antifungals, or antivirals for treatment of active infection within 24 hours before study randomization any prescription or herbal product that is not approved by the investigator long-term treatment (> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor receipt of systemic immunosuppressive therapy within 3 months before screening

2

Stanford University

18

75

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

120

Duration Until Viral Shedding Cessation

None

Phase 2

[{"arm_notes": "Area under the curve of SARS-COV-2 viral load;Number of participants requiring emergency department visits or hospitalizations within 28 days of initiation of treatment;Sars-CoV-2 viral load;Time to alleviation of all symptoms Time to alleviation of all symptoms", "treatment_id": 967, "treatment_name": "Pegylated interferon lambda", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Area under the curve of SARS-COV-2 viral load;Number of participants requiring emergency department visits or hospitalizations within 28 days of initiation of treatment;Sars-CoV-2 viral load;Time to alleviation of all symptoms Time to alleviation of all symptoms", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]