search
Back to results

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

Primary Purpose

Sars-CoV-2 Infection

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Peginterferon lambda alfa-1a subcutaneous injection
Saline
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sars-CoV-2 Infection focused on measuring SARS-CoV-2, COVID-19, Lambda interferon

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Peginterferon lambda alfa-1a

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants With no Evidence of SARS-CoV-2 Infection
Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28.

Secondary Outcome Measures

Time to no Detection of SARS-CoV-2
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.

Full Information

First Posted
April 10, 2020
Last Updated
July 12, 2022
Sponsor
Johns Hopkins University
Collaborators
Eiger BioPharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT04344600
Brief Title
Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection
Acronym
PROTECT
Official Title
Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Single center study with low enrollment
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
September 24, 2021 (Actual)
Study Completion Date
September 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Eiger BioPharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV-2 Infection
Keywords
SARS-CoV-2, COVID-19, Lambda interferon

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, single-blind, controlled trial
Masking
Participant
Masking Description
Single-blinded study
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peginterferon lambda alfa-1a
Arm Type
Experimental
Arm Description
peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2
Intervention Type
Drug
Intervention Name(s)
Peginterferon lambda alfa-1a subcutaneous injection
Intervention Description
Peginterferon lambda-1a 180 micrograms by subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Saline subcutaneous injection
Primary Outcome Measure Information:
Title
Number of Participants With no Evidence of SARS-CoV-2 Infection
Description
Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28.
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Time to no Detection of SARS-CoV-2
Description
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.
Time Frame
Up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Sulkowski, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29270173
Citation
Hemann EA, Gale M Jr, Savan R. Interferon Lambda Genetics and Biology in Regulation of Viral Control. Front Immunol. 2017 Dec 6;8:1707. doi: 10.3389/fimmu.2017.01707. eCollection 2017.
Results Reference
background
PubMed Identifier
20335250
Citation
Mordstein M, Neugebauer E, Ditt V, Jessen B, Rieger T, Falcone V, Sorgeloos F, Ehl S, Mayer D, Kochs G, Schwemmle M, Gunther S, Drosten C, Michiels T, Staeheli P. Lambda interferon renders epithelial cells of the respiratory and gastrointestinal tracts resistant to viral infections. J Virol. 2010 Jun;84(11):5670-7. doi: 10.1128/JVI.00272-10. Epub 2010 Mar 24.
Results Reference
background
PubMed Identifier
14693875
Citation
Loutfy MR, Blatt LM, Siminovitch KA, Ward S, Wolff B, Lho H, Pham DH, Deif H, LaMere EA, Chang M, Kain KC, Farcas GA, Ferguson P, Latchford M, Levy G, Dennis JW, Lai EK, Fish EN. Interferon alfacon-1 plus corticosteroids in severe acute respiratory syndrome: a preliminary study. JAMA. 2003 Dec 24;290(24):3222-8. doi: 10.1001/jama.290.24.3222.
Results Reference
background
PubMed Identifier
32788708
Citation
Lee JS, Shin EC. The type I interferon response in COVID-19: implications for treatment. Nat Rev Immunol. 2020 Oct;20(10):585-586. doi: 10.1038/s41577-020-00429-3.
Results Reference
derived
Links:
URL
https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus/en/
Description
WHO COVID-19 landscape analysis of therapeutics.

Learn more about this trial

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

We'll reach out to this number within 24 hrs