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

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ClinicalTrials.gov Identifier: NCT04344600
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : July 19, 2021
Sponsor:
Collaborator:
Eiger BioPharmaceuticals
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE April 10, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date July 19, 2021
Actual Study Start Date  ICMJE June 29, 2020
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection
Official Title  ICMJE Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Sars-CoV2
Intervention  ICMJE
  • Drug: Peginterferon lambda alfa-1a subcutaneous injection
    Peginterferon lambda-1a 180 micrograms by subcutaneous injection
  • Other: Saline
    Saline subcutaneous injection
Study Arms  ICMJE
  • Experimental: Peginterferon lambda alfa-1a
    peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2
    Intervention: Drug: Peginterferon lambda alfa-1a subcutaneous injection
  • Placebo Comparator: Placebo
    Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2
    Intervention: Other: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2020)
164
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark Sulkowski, MD 410-955-7538 msulkowski@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04344600
Other Study ID Numbers  ICMJE IRB00248163
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Eiger BioPharmaceuticals
Investigators  ICMJE
Principal Investigator: Mark Sulkowski, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP