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

• ClinicalTrials.gov Identifier: NCT04344600
• Recruitment Status: Terminated
• First Posted: April 14, 2020
• Results First Posted: July 14, 2022
• Last Update Posted: July 14, 2022
• Sponsor: Johns Hopkins University
• Collaborator: Eiger BioPharmaceuticals
• Information provided by (Responsible Party): Johns Hopkins University

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 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: June 29, 2020
• Actual Primary Completion Date: September 24, 2021
• Actual Study Completion Date: September 24, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Eiger BioPharmaceuticals

Investigators

• Principal Investigator: Mark Sulkowski, MD; Johns Hopkins University

  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Study Protocol and Statistical Analysis Plan  [PDF] September 18, 2020

More Information

Additional Information:

WHO COVID-19 landscape analysis of therapeutics. 

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT04344600
• Other Study ID Numbers: IRB00248163
• First Posted: April 14, 2020
• Results First Posted: July 14, 2022
• Last Update Posted: July 14, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Infections; Communicable Diseases; COVID-19; Disease Attributes; Pathologic Processes; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases