Status and phase
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About
To evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of Peginterferon Lambda-1a, compared with placebo in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.
Full description
Patients will attend up to 9 study visits over a period of up to 28 days.
Enrollment
Sex
Ages
Volunteers
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:
Exclusion criteria
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:
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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