Trial Outcomes & Findings for Pegylated Interferon Lambda Treatment for COVID-19 (NCT NCT04343976)

NCT ID: NCT04343976

Last Updated: 2022-07-21

Results Overview

Negative COVID PCR testing 7 days after first lambda dose

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2022-07-21

Participant Flow

Subjects were recruited from inpatient admissions between June 2020 and July 2021.

Participant milestones

Measure	Lambda Treatment Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Saline Placebo Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Overall Study STARTED	7	7
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Lambda Treatment Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Saline Placebo Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Pegylated Interferon Lambda Treatment for COVID-19

Baseline characteristics by cohort

Measure	Lambda Treatment n=7 Participants Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Saline Placebo n=7 Participants Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	54 years n=5 Participants	59 years n=7 Participants	54.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Subjects with Day 7 qPCR result of NEG (negative), meaning that no amplification was observed.

Negative COVID PCR testing 7 days after first lambda dose

Outcome measures

Measure	Lambda Treatment n=7 Participants Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Saline Placebo n=7 Participants Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Undetectable COVID PCR at Day 7	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 3 days

Negative COVID PCR testing 3 days after first lambda dose

Outcome measures

Measure	Lambda Treatment n=7 Participants Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Saline Placebo n=6 Participants Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Undetectable COVID PCR at Day 3	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: insufficient data, analysis not performed as there the symptom improvement score was not collected and not available for analysis.

Daily symptom score improvement during treatment period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: Data was not collected and therefor analysis not performed.

Time to event for death, intubation, hospital discharge

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Population: All subjects providing NP swab samples at Day 14

Negative COVID PCR testing 14 days after first lambda dose

Outcome measures

Measure	Lambda Treatment n=6 Participants Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Saline Placebo n=6 Participants Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Undetectable COVID PCR Testing at Day 14	2 Participants	2 Participants

Adverse Events

Lambda Treatment

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Saline Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lambda Treatment n=7 participants at risk Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Saline Placebo n=7 participants at risk Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Hepatobiliary disorders Transaminitis	14.3% 1/7 • Number of events 1 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.	0.00% 0/7 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.
Respiratory, thoracic and mediastinal disorders Worsening Pneumonia	14.3% 1/7 • Number of events 1 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.	0.00% 0/7 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.

Other adverse events

Measure	Lambda Treatment n=7 participants at risk Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda	Saline Placebo n=7 participants at risk Subcutaneous injection of saline placebo Pegylated interferon lambda: 180 mcg subcutaneous injection of pegylated interferon lambda
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.00% 0/7 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.	14.3% 1/7 • Number of events 1 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.
Cardiac disorders Chest Pain	0.00% 0/7 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.	14.3% 1/7 • Number of events 1 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.
Gastrointestinal disorders Stomach Pain (unspecified)	14.3% 1/7 • Number of events 1 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.	0.00% 0/7 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.
Hepatobiliary disorders Transaminitis	14.3% 1/7 • Number of events 1 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.	0.00% 0/7 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.
Psychiatric disorders ICU Delirium	14.3% 1/7 • Number of events 1 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.	0.00% 0/7 • Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.

Additional Information

Sponsor-Investigator

Massachusetts General Hospital

Phone: 617-724-3836

Email: chung.raymond@mgh.harvard.edu

Results disclosure agreements

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