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

Phase 2TerminatedNCT04344600

Johns Hopkins University6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Sars-CoV-2 Infection

Interventions

Peginterferon lambda alfa-1a subcutaneous injectionDRUG

Peginterferon lambda-1a 180 micrograms by subcutaneous injection

SalineOTHER

Saline subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Number of Participants With no Evidence of SARS-CoV-2 Infection

Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28.

Time frame: Up to 28 days

Secondary Outcomes

Time to no Detection of SARS-CoV-2

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.

Time frame: Up to 14 days

Data from ClinicalTrials.gov

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