Phase 2
Completed N=120
Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19
Source: ClinicalTrials.gov NCT04331899 ↗Enrolled (actual)
120
Serious AEs
3.3%
Results posted
Apr 2021
Primary outcomePrimary: Duration Until Viral Shedding Cessation — 7; 7 days — p=0.29
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration Until Viral Shedding Cessation |
7; 7 | 0.29 |
| SECONDARY Change in Sars-CoV-2 Viral Load |
-4.3; -4.9 | 0.91 |
| SECONDARY Area Under the Curve of SARS-COV-2 Viral Load |
28.5; 29.6 | 0.95 |
| SECONDARY Duration Until Resolution of Symptoms |
8; 9 | 0.76 |
| SECONDARY Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment |
2; 2; 5; 3 | — |
Eligibility Criteria
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
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 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
Data sourced from ClinicalTrials.gov (NCT04331899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.