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

Sars-CoV-2 Infection Clinical Trial

— PROTECT  

Official title:

Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04344600
• Other study ID #: IRB00248163
• Status: Terminated
• Phase: Phase 2
• Start date: June 29, 2020
• Est. completion date: September 24, 2021

Study information

• Verified date: July 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 24, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Sars-CoV-2 Infection

Intervention

Drug:
• Peginterferon lambda alfa-1a subcutaneous injection
Peginterferon lambda-1a 180 micrograms by subcutaneous injection

Other:
• Saline
Saline subcutaneous injection

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Eiger BioPharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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. — View Citation

Mordstein M, Neugebauer E, Ditt V, Jessen B, Rieger T, Falcone V, Sorgeloos F, Ehl S, Mayer D, Kochs G, Schwemmle M, Günther 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 14 days

External Links

•   WHO COVID-19 landscape analysis of therapeutics.