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

July 12, 2022 updated by: Johns Hopkins University

Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Peginterferon lambda alfa-1a
peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2
Drug: Peginterferon lambda alfa-1a subcutaneous injection
Peginterferon lambda-1a 180 micrograms by subcutaneous injection
PLACEBO_COMPARATOR: Placebo
Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2
Other: Saline
Saline subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With no Evidence of SARS-CoV-2 Infection
Time Frame: Up to 28 days
Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28.
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to no Detection of SARS-CoV-2
Time Frame: 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.
Up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Eiger BioPharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 29, 2020

Primary Completion (ACTUAL)

September 24, 2021

Study Completion (ACTUAL)

September 24, 2021

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (ACTUAL)

April 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00248163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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