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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04344600
• Collaborator: Eiger BioPharmaceuticals (Industry)
• Enrollment: 6
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 0.4

Study Details

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
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, randomized, single-blind, controlled trialProspective, 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: Jun 29, 2020
• Actual Primary Completion Date: Sep 24, 2021
• Actual Study Completion Date: Sep 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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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)

• Study Protocol and Statistical Analysis Plan - Sep 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. Review.
• 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.
• 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.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT04344600
• Other Study ID Numbers: IRB00248163
• First Posted: Apr 14, 2020
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

Participant Flow

Arm/Group Title	Peginterferon Lambda Alfa-1a	Placebo
Arm/Group Description	peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2 Peginterferon lambda alfa-1a subcutaneous injection: Peginterferon lambda-1a 180 micrograms by subcutaneous injection	Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Saline: Saline subcutaneous injection
Period Title: Overall Study
STARTED	2	4
COMPLETED	2	4
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Peginterferon Lambda Alfa-1a	Placebo	Total
Arm/Group Description	peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2 Peginterferon lambda alfa-1a subcutaneous injection: Peginterferon lambda-1a 180 micrograms by subcutaneous injection	Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Saline: Saline subcutaneous injection	Total of all reporting groups
Overall Participants	2	4	6
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 50%	2 50%	3 50%
>=65 years	1 50%	2 50%	3 50%
Sex: Female, Male (Count of Participants)
Female	2 100%	3 75%	5 83.3%
Male	0 0%	1 25%	1 16.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	2 100%	4 100%	6 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 25%	1 16.7%
White	2 100%	3 75%	5 83.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peginterferon Lambda Alfa-1a	Placebo
Arm/Group Description	peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2 Peginterferon lambda alfa-1a subcutaneous injection: Peginterferon lambda-1a 180 micrograms by subcutaneous injection	Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Saline: Saline subcutaneous injection
Measure Participants	2	4
Count of Participants [Participants]	2 100%	4 100%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This outcome was not assessed because all participants were negative at the time of entering study and didn't test positive. No data was collected.

Arm/Group Title	Peginterferon Lambda Alfa-1a	Placebo
Arm/Group Description	peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2 Peginterferon lambda alfa-1a subcutaneous injection: Peginterferon lambda-1a 180 micrograms by subcutaneous injection	Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Saline: Saline subcutaneous injection
Measure Participants	0	0

Adverse Events

Time Frame	Adverse event data were collected from the time of informed consent through protocol Day 28
Arm/Group Title	Peginterferon Lambda Alfa-1a		Placebo
Arm/Group Description	peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2 Peginterferon lambda alfa-1a subcutaneous injection: Peginterferon lambda-1a 180 micrograms by subcutaneous injection		Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Saline: Saline subcutaneous injection
All Cause Mortality
	Peginterferon Lambda Alfa-1a		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/4 (0%)
Serious Adverse Events
	Peginterferon Lambda Alfa-1a		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Peginterferon Lambda Alfa-1a		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.