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Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19 (COVID-Lambda)

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ClinicalTrials.gov Identifier: NCT04331899
Recruitment Status : Active, not recruiting
First Posted : April 2, 2020
Results First Posted : April 22, 2021
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition COVID-19
Interventions Drug: Peginterferon Lambda-1a
Other: Placebo
Enrollment 120
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Lambda Placebo
Hide Arm/Group Description Peginterferon Lambda-1a (Lambda) single dose administered subcutaneously in addition to standard of care treatment. Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
Period Title: Overall Study
Started 60 60
Completed the Trial Portion of the Study 58 58
Completed 16 15
Not Completed 44 45
Reason Not Completed
Continuing in follow-up             42             43
Withdrawal by Subject             2             2
Arm/Group Title Lambda Placebo Total
Hide Arm/Group Description Lambda single dose administered subcutaneously in addition to standard of care treatment. Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment. Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
37
(18 to 66)
34
(20 to 71)
36
(18 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
24
  40.0%
26
  43.3%
50
  41.7%
Male
36
  60.0%
34
  56.7%
70
  58.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Latinx
34
  56.7%
41
  68.3%
75
  62.5%
White
18
  30.0%
15
  25.0%
33
  27.5%
Asian
3
   5.0%
4
   6.7%
7
   5.8%
Native Hawaiian or other Pacific Islander
2
   3.3%
0
   0.0%
2
   1.7%
Unknown
2
   3.3%
0
   0.0%
2
   1.7%
More than one race
1
   1.7%
0
   0.0%
1
   0.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 60 participants 60 participants 120 participants
60
 100.0%
60
 100.0%
120
 100.0%
Duration of symptoms prior to randomization  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 60 participants 60 participants 120 participants
4
(3 to 6)
5
(3 to 5)
5
(3 to 9)
Asymptomatic at baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
6
  10.0%
2
   3.3%
8
   6.7%
Symptoms at baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Fatigue
33
  55.0%
42
  70.0%
75
  62.5%
Cough
33
  55.0%
36
  60.0%
69
  57.5%
Headache
29
  48.3%
36
  60.0%
65
  54.2%
Myalgias
29
  48.3%
34
  56.7%
63
  52.5%
Decreased taste or smell
25
  41.7%
32
  53.3%
57
  47.5%
Chills
22
  36.7%
27
  45.0%
49
  40.8%
Sore throat
22
  36.7%
23
  38.3%
45
  37.5%
Joint pain
19
  31.7%
19
  31.7%
38
  31.7%
Diarrhea
16
  26.7%
18
  30.0%
34
  28.3%
Nausea
11
  18.3%
23
  38.3%
34
  28.3%
Shortness of breath
16
  26.7%
16
  26.7%
32
  26.7%
Chest pain/pressure
14
  23.3%
13
  21.7%
27
  22.5%
Runny nose
10
  16.7%
16
  26.7%
26
  21.7%
Abdominal pain
7
  11.7%
7
  11.7%
14
  11.7%
Rash
4
   6.7%
5
   8.3%
9
   7.5%
Vomiting
1
   1.7%
5
   8.3%
6
   5.0%
Body temperature ≥99.5°F  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
6
  10.0%
7
  11.7%
13
  10.8%
Oxygen saturation  
Median (Inter-Quartile Range)
Unit of measure:  Percentage of peripheral capillary O2
Number Analyzed 60 participants 60 participants 120 participants
98
(97 to 100)
99
(97 to 99.5)
98
(97 to 100)
White blood cell count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/μl
Number Analyzed 60 participants 60 participants 120 participants
5.5
(4.3 to 6.8)
5.6
(4.0 to 7.5)
5.5
(4.1 to 7.1)
Absolute lymphocyte count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/μl
Number Analyzed 60 participants 60 participants 120 participants
1.5
(1.2 to 1.9)
1.5
(1.2 to 2.3)
1.5
(1.2 to 2.2)
1.Primary Outcome
Title Duration Until Viral Shedding Cessation
Hide Description Time to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR.
Time Frame Assessed for up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lambda Placebo
Hide Arm/Group Description:
Lambda single dose administered subcutaneously in addition to standard of care treatment.
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
Overall Number of Participants Analyzed 60 60
Median (95% Confidence Interval)
Unit of Measure: days
7
(5 to 13)
7
(5 to 10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lambda, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments Tests were conducted at the 0.05 level of significance.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.56 to 1.19
Estimation Comments Cox proportional hazards model covariate-adjusted for age 50+ and sex.
2.Secondary Outcome
Title Change in Sars-CoV-2 Viral Load
Hide Description Log10 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.
Time Frame baseline, day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lambda Placebo
Hide Arm/Group Description:
Lambda single dose administered subcutaneously in addition to standard of care treatment.
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: Log10 copies per mL
-4.3  (1.3) -4.9  (4.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lambda, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments Tests were conducted at the 0.05 level of significance.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-1.23 to 1.11
Estimation Comments Log change at Day 14. Cox proportional hazards model covariate-adjusted for age 50+ and sex.
3.Secondary Outcome
Title Area Under the Curve of SARS-COV-2 Viral Load
Hide Description Log10 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.
Time Frame baseline through day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lambda Placebo
Hide Arm/Group Description:
Lambda single dose administered subcutaneously in addition to standard of care treatment.
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
Overall Number of Participants Analyzed 60 60
Median (Inter-Quartile Range)
Unit of Measure: Log10 copies*days/ml
28.5
(18.6 to 39.1)
29.6
(19.6 to 38.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lambda, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments Tests were conducted at the 0.05 level of significance.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.85 to 1.16
Estimation Comments Cox proportional hazards model covariate-adjusted for age 50+ and sex.
4.Secondary Outcome
Title Duration Until Resolution of Symptoms
Hide Description Duration 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.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lambda Placebo
Hide Arm/Group Description:
Lambda single dose administered subcutaneously in addition to standard of care treatment.
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
Overall Number of Participants Analyzed 60 60
Median (95% Confidence Interval)
Unit of Measure: days
8
(6 to 11)
9
(5 to 11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lambda, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments Tests were conducted at the 0.05 level of significance.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.60 to 1.41
Estimation Comments Cox proportional hazards model covariate-adjusted for age 50+ and sex.
5.Secondary Outcome
Title Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lambda Placebo
Hide Arm/Group Description:
Lambda single dose administered subcutaneously in addition to standard of care treatment.
Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Hospitalizations
2
   3.3%
2
   3.3%
Emergency Department Visits
5
   8.3%
3
   5.0%
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lambda Placebo
Hide Arm/Group Description Lambda single dose administered subcutaneously in addition to standard of care treatment. Placebo to match Lambda single dose administered subcutaneously in addition to standard of care treatment.
All-Cause Mortality
Lambda Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Hide Serious Adverse Events
Lambda Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/60 (3.33%)   2/60 (3.33%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia (hospital admission)   2/60 (3.33%)  2/60 (3.33%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lambda Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   15/60 (25.00%)   5/60 (8.33%) 
Hepatobiliary disorders     
Elevated liver function test   15/60 (25.00%)  5/60 (8.33%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Prasanna Jagannathan, MD
Organization: Stanford University
Phone: 1-650-724-5343
EMail: prasj@stanford.edu
Layout table for additonal information
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04331899    
Other Study ID Numbers: 55619
First Submitted: March 27, 2020
First Posted: April 2, 2020
Results First Submitted: April 8, 2021
Results First Posted: April 22, 2021
Last Update Posted: April 22, 2021