Status:
COMPLETED
Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19
Lead Sponsor:
Stanford University
Conditions:
COVID-19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 patie...
Detailed Description
Patients will attend up to 9 study visits over a period of up to 28 days.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04331899
Start Date
April 25 2020
End Date
May 6 2021
Last Update
November 30 2021
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305