Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Other: Placebo; Drug: Peginterferon Lambda-1a

• Registration Number: NCT04331899
• Lead Sponsor: Stanford University

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 patients with uncomplicated COVID-19 disease.

Detailed Description

Patients will attend up to 9 study visits over a period of up to 28 days.

Study Timeline

• Study First Submitted: 2020-03-27
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Study Start: 2020-04-25
• Primary Completion: 2020-08-14
• Results First Submitted: 2021-04-08
• Results First Submitted QC: 2021-04-19
• Results First Posted: 2021-04-22
• Study Completion: 2021-05-06
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age ≥ 18 years and ≤ 75 years at the time of the assessment

2. Able and willing to understand the study, adhere to all study procedures, and provide written informed consent

3. Diagnosis of COVID-19 disease:

   1. 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:
   2. 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

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Exclusion Criteria

1. Patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent

2. Patients with a known allergy to Peginterferon Lambda-1a or any component thereof

3. Display symptoms of respiratory distress (Respiratory rate >20, room air oxygen saturation of <94%.)

4. Participation in a clinical trial with or use of any investigational agent within 30 days before screening

5. Treatment with interferons (IFN) within 12 months before screening

6. Previous use of Peginterferon Lambda-1a

7. History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.

8. Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.

9. Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma

10. Co-infected with human immunodeficiency virus (HIV)

11. Significant abnormal laboratory test results at screening.

12. Other significant medical condition that may require intervention during the study

13. Concurrent use of any of the following medications:

    1. Therapy with an immunomodulatory agent
    2. Current use of heparin or Coumadin
    3. Received blood products within 30 days before study randomization
    4. Use of hematologic growth factors within 30 days before study randomization
    5. Systemic antibiotics, antifungals, or antivirals for treatment of active infection within 24 hours before study randomization
    6. Any prescription or herbal product that is not approved by the investigator
    7. Long-term treatment (> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor
    8. Receipt of systemic immunosuppressive therapy within 3 months before screening

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo injection	Placebo	Study participants will receive a placebo along with the standard of care treatment.
Study drug Peginterferon Lambda-1a	Peginterferon Lambda-1a	Study participants assigned to study drug will receive a single subcutaneous dose of Peginterferon Lambda-1a in addition to standard of care treatment.

Primary Outcome Measures

Name	Time	Method
Duration Until Viral Shedding Cessation	Assessed for up to 28 days	Time to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR.

Secondary Outcome Measures

Name	Time	Method
Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment	28 days
Duration Until Resolution of Symptoms	Up to 28 days	Duration until resolution of symptoms in days, median (95% CI). Time to alleviation of all symptoms (fever, chills, cough, nasal congestion, muscle pains), defined as the time from initiation of treatment until all symptoms are rated as absent or mild in symptomatic patients.
Change in Sars-CoV-2 Viral Load	baseline, day 14	Log10 Oropharyngeal viral load over time, mean change at day 14 (SD). Sars-CoV-2 RNA level in oropharyngeal and/or anterior nare swabs collected daily.
Area Under the Curve of SARS-COV-2 Viral Load	baseline through day 14	Log10 viral load area under the curve through day 14, median (IQR). Area under the curve of SARS-CoV-2 viral load in oropharyngeal and/or anterior nare swabs collected daily.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States