Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection

Phase 2

Terminated

• Conditions: Sars-CoV-2 Infection
• Interventions: Drug: Peginterferon lambda alfa-1a subcutaneous injection; Other: Saline

• Registration Number: NCT04344600
• Lead Sponsor: Johns Hopkins University

Brief Summary

This is a phase 2b prospective, randomized, single-blind, controlled trial of a single subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2 infection in non-hospitalized participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All participants will be followed for up to 12 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-14
• Study Start: 2020-06-29
• Primary Completion: 2021-09-24
• Study Completion: 2021-09-24
• Results First Submitted: 2022-06-01
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-12
• Last Update Submitted: 2022-07-12
• Results First Posted: 2022-07-14
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Willing and able to provide written informed consent
• Peripheral capillary oxygen saturation (SpO2) ≥ 95% on room air at screening
• Age ≥18 years

Exclusion Criteria

• Hospitalized or impending hospitalization at the time of screening
• Symptoms of cough, fever or shortness of breath within 72 hours
• Prior or current treatment with other experimental or approved agents targeting SARS-CoV-2 or SARS-CoV-1
• Positive pregnancy test
• Active autoimmune disease or sarcoidosis (with the exception of controlled thyroid disease)
• Active decompensated liver disease (ascites, encephalopathy)
• Active congestive heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peginterferon lambda alfa-1a	Peginterferon lambda alfa-1a subcutaneous injection	peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2
Placebo	Saline	Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2

Primary Outcome Measures

Name	Time	Method
Number of Participants With no Evidence of SARS-CoV-2 Infection	Up to 28 days	Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28.

Secondary Outcome Measures

Name	Time	Method
Time to no Detection of SARS-CoV-2	Up to 14 days	Resolution of SARS-CoV-2 infection in the upper respiratory tract as assessed by time (in days) to no detection of SARS-CoV-2 in two upper respiratory samples.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States