Trial Outcomes & Findings for Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection (NCT NCT04344600)

NCT ID: NCT04344600

Last Updated: 2022-07-14

Results Overview

Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Up to 28 days
• Results posted on: 2022-07-14

Participant Flow

Participant milestones

Measure	Peginterferon Lambda Alfa-1a 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 Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Saline: Saline subcutaneous injection
Overall Study STARTED	2	4
Overall Study COMPLETED	2	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Peginterferon Lambda Alfa-1a n=2 Participants 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 n=4 Participants Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Saline: Saline subcutaneous injection	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28.

Outcome measures

Measure	Peginterferon Lambda Alfa-1a n=2 Participants 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 n=4 Participants Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 Saline: Saline subcutaneous injection
Number of Participants With no Evidence of SARS-CoV-2 Infection	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 14 days

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Peginterferon Lambda Alfa-1a

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Sulkowski

Johns Hopkins School of Medicine

Phone: 410-955-7538

Email: msulkowski@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place