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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-29

Study Completion Date

2021-09-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04331899

COVID-19

COMPLETED PHASE2

Pegylated Interferon Lambda Treatment for COVID-19

NCT04343976

COVID-19 COVID

TERMINATED PHASE2

Interferon Lambda Therapy for COVID-19

NCT04388709

SARS-CoV-2

WITHDRAWN PHASE2

Pegylated Interferon Lambda for Treatment of COVID-19 Infection

NCT04534673

COVID-19

UNKNOWN PHASE2

Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19

NCT04354259

Sars-CoV2 Covid-19

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sars-CoV-2 Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, single-blind, controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Single-blinded study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Peginterferon lambda alfa-1a

peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2

Group Type EXPERIMENTAL

Peginterferon lambda alfa-1a subcutaneous injection

Intervention Type DRUG

Peginterferon lambda-1a 180 micrograms by subcutaneous injection

Placebo

Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Saline subcutaneous injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peginterferon lambda alfa-1a subcutaneous injection

Peginterferon lambda-1a 180 micrograms by subcutaneous injection

Intervention Type DRUG

Saline

Saline subcutaneous injection

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No