Clinical trial NCT04344600: Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection
Official title: Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sars-CoV-2 Infection
Keywords: SARS-CoV-2
COVID-19
Lambda interferon
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eiger BioPharmaceuticals
First posted: 2020-04-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, single-blind, controlled trial
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of Participants With no Evidence of SARS-CoV-2 Infection
timeFrame: Up to 28 days
Secondary outcomes:
measure: Time to no Detection of SARS-CoV-2
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mark Sulkowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.