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

Johns Hopkins University

Status and phase

Terminated

Phase 2

Conditions

Sars-CoV-2 Infection

Treatments

Other: Saline

Drug: Peginterferon lambda alfa-1a subcutaneous injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04344600

IRB00248163

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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