Trial Outcomes & Findings for Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19 (NCT NCT04331899)
NCT ID: NCT04331899
Last Updated: 2021-11-30
Results Overview
Time to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Assessed for up to 28 days
Results posted on
2021-11-30
Participant Flow
Enrollment opened on April 24, 2020. The first patient was enrolled on April 25, 2020, and the last patient was enrolled on July 17, 2020.
Participant milestones
| Measure |
Lambda
Peginterferon Lambda-1a (Lambda) single dose administered subcutaneously in addition to standard of care treatment.
|
Placebo
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
|---|---|---|
|
Trial Period (28 Days)
STARTED
|
60
|
60
|
|
Trial Period (28 Days)
COMPLETED
|
58
|
58
|
|
Trial Period (28 Days)
NOT COMPLETED
|
2
|
2
|
|
Follow-up Period (10 Months)
STARTED
|
42
|
43
|
|
Follow-up Period (10 Months)
COMPLETED
|
42
|
43
|
|
Follow-up Period (10 Months)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lambda
Peginterferon Lambda-1a (Lambda) single dose administered subcutaneously in addition to standard of care treatment.
|
Placebo
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
|---|---|---|
|
Trial Period (28 Days)
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19
Baseline characteristics by cohort
| Measure |
Lambda
n=60 Participants
Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
Placebo
n=60 Participants
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
n=99 Participants
|
34 years
n=107 Participants
|
36 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Latinx
|
34 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Duration of symptoms prior to randomization
|
4 days
n=99 Participants
|
5 days
n=107 Participants
|
5 days
n=206 Participants
|
|
Asymptomatic at baseline
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Symptoms at baseline
Fatigue
|
33 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Symptoms at baseline
Cough
|
33 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Symptoms at baseline
Headache
|
29 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Symptoms at baseline
Myalgias
|
29 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Symptoms at baseline
Decreased taste or smell
|
25 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Symptoms at baseline
Chills
|
22 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Symptoms at baseline
Sore throat
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Symptoms at baseline
Joint pain
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Symptoms at baseline
Diarrhea
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Symptoms at baseline
Nausea
|
11 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Symptoms at baseline
Shortness of breath
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Symptoms at baseline
Chest pain/pressure
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Symptoms at baseline
Runny nose
|
10 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Symptoms at baseline
Abdominal pain
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Symptoms at baseline
Rash
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Symptoms at baseline
Vomiting
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Body temperature ≥99.5°F
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Oxygen saturation
|
98 percentage of peripheral capillary O2
n=99 Participants
|
99 percentage of peripheral capillary O2
n=107 Participants
|
98 percentage of peripheral capillary O2
n=206 Participants
|
|
White blood cell count
|
5.5 cells/μl
n=99 Participants
|
5.6 cells/μl
n=107 Participants
|
5.5 cells/μl
n=206 Participants
|
|
Absolute lymphocyte count
|
1.5 cells/μl
n=99 Participants
|
1.5 cells/μl
n=107 Participants
|
1.5 cells/μl
n=206 Participants
|
PRIMARY outcome
Timeframe: Assessed for up to 28 daysTime to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR.
Outcome measures
| Measure |
Lambda
n=60 Participants
Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
Placebo
n=60 Participants
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
|---|---|---|
|
Duration Until Viral Shedding Cessation
|
7 days
Interval 5.0 to 13.0
|
7 days
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: baseline, day 14Log10 Oropharyngeal viral load over time, mean change at day 14 (SD). Sars-CoV-2 RNA level in oropharyngeal and/or anterior nare swabs collected daily.
Outcome measures
| Measure |
Lambda
n=60 Participants
Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
Placebo
n=60 Participants
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
|---|---|---|
|
Change in Sars-CoV-2 Viral Load
|
-4.3 Log10 copies per mL
Standard Deviation 1.3
|
-4.9 Log10 copies per mL
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: baseline through day 14Log10 viral load area under the curve through day 14, median (IQR). Area under the curve of SARS-CoV-2 viral load in oropharyngeal and/or anterior nare swabs collected daily.
Outcome measures
| Measure |
Lambda
n=60 Participants
Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
Placebo
n=60 Participants
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
|---|---|---|
|
Area Under the Curve of SARS-COV-2 Viral Load
|
28.5 Log10 copies*days/ml
Interval 18.6 to 39.1
|
29.6 Log10 copies*days/ml
Interval 19.6 to 38.7
|
SECONDARY outcome
Timeframe: Up to 28 daysDuration until resolution of symptoms in days, median (95% CI). Time to alleviation of all symptoms (fever, chills, cough, nasal congestion, muscle pains), defined as the time from initiation of treatment until all symptoms are rated as absent or mild in symptomatic patients.
Outcome measures
| Measure |
Lambda
n=60 Participants
Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
Placebo
n=60 Participants
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
|---|---|---|
|
Duration Until Resolution of Symptoms
|
8 days
Interval 6.0 to 11.0
|
9 days
Interval 5.0 to 11.0
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Lambda
n=60 Participants
Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
Placebo
n=60 Participants
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
|---|---|---|
|
Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment
Hospitalizations
|
2 Participants
|
2 Participants
|
|
Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment
Emergency Department Visits
|
5 Participants
|
3 Participants
|
Adverse Events
Lambda
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lambda
n=60 participants at risk
Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
Placebo
n=60 participants at risk
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia (hospital admission)
|
3.3%
2/60 • 11 months
|
3.3%
2/60 • 11 months
|
Other adverse events
| Measure |
Lambda
n=60 participants at risk
Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
Placebo
n=60 participants at risk
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
|
|---|---|---|
|
Hepatobiliary disorders
Elevated liver function test
|
25.0%
15/60 • 11 months
|
8.3%
5/60 • 11 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place