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

NCT04344600 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00248163
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Sars-CoV-2 Infection

Keywords

SARS-CoV-2; COVID-19; Lambda interferon

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 28 days

Secondary Outcomes (1)

• Time to no Detection of SARS-CoV-2

  Up to 14 days

Study Arms (2)

Peginterferon lambda alfa-1a

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Saline

Interventions

Peginterferon lambda alfa-1a subcutaneous injection DRUG

Peginterferon lambda-1a 180 micrograms by subcutaneous injection

Peginterferon lambda alfa-1a

Saline OTHER

Saline subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent
• Peripheral capillary oxygen saturation (SpO2) ≥ 95% on room air at screening
• Age ≥18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eiger BioPharmaceuticals: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

• 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.

  PMID: 29270173 BACKGROUND

• 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.

  PMID: 20335250 BACKGROUND

• 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.

  PMID: 14693875 BACKGROUND

• 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.

  PMID: 32788708 DERIVED

Related Links

• WHO COVID-19 landscape analysis of therapeutics.

MeSH Terms

Conditions

COVID-19

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Mark Sulkowski
• Organization: Johns Hopkins School of Medicine

msulkowski@jhmi.edu

410-955-7538

Study Officials

• Mark Sulkowski, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, single-blind, controlled trial

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: June 29, 2020
• Primary Completion: September 24, 2021
• Study Completion: September 24, 2021
• Last Updated: July 14, 2022
• Results First Posted: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)