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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344600
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
Eiger BioPharmaceuticals
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This is a phase 2b prospective, randomized, single-blind, controlled trial of two weekly subcutaneous injections of lambda interferon alfa-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.

Condition or disease Intervention/treatment Phase
Sars-CoV2 Drug: Peginterferon lambda alfa-1a subcutaneous injection Other: Saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, single-blind, controlled trial
Masking: Single (Participant)
Masking Description: Single-blinded study
Primary Purpose: Prevention
Official Title: Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection
Actual Study Start Date : May 29, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

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




Primary Outcome Measures :
  1. Proportion of participants with no evidence of SARS-CoV-2 infection [ Time Frame: Up to 28 days ]
    No evidence of SARS-CoV-2 infection at or before study day 28

  2. Time (days) to no detection of SARS-CoV-2 in two upper respiratory samples [ Time Frame: Up to 14 days ]
    Resolution of SARS-CoV-2 infection in the upper respiratory tract



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344600


Contacts
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Contact: Stephanie Katz, RN, MSN 410-955-7538 ssneddo2@jhmi.edu
Contact: Mark Sulkowski, MD 410-955-7538 msulkowski@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Stephanie Katz, RN, MSN    410-955-7568    ssneddo2@jhmi.edu   
Contact: Mark Sulkowski, MD    410-955-7538    msulkowski@jhmi.edu   
Principal Investigator: Mark S. Sulkowski, MD         
Sponsors and Collaborators
Johns Hopkins University
Eiger BioPharmaceuticals
Investigators
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Principal Investigator: Mark Sulkowski, MD Johns Hopkins University
Additional Information:
Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04344600    
Other Study ID Numbers: IRB00248163
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
SARS-CoV-2
COVID-19
Lambda interferon
Additional relevant MeSH terms:
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Infection