Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19 (COVID-Lambda)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Peginterferon Lambda-1a Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||An open-label, single-blind randomized controlled trial. Study participants will be randomly assigned 1:1 to a single subcutaneous dose of Peginterferon Lambda-1a or placebo along with the standard of care.|
|Masking Description:||Single-blind study in which only patients are blinded.|
|Official Title:||A Phase 2 Randomized, Single-Blind Study of a Single Dose of Peginterferon Lambda-1a (Lambda) Compared With Placebo in Outpatients With Mild COVID-19|
|Actual Study Start Date :||April 25, 2020|
|Actual Primary Completion Date :||August 14, 2020|
|Estimated Study Completion Date :||May 2021|
Experimental: Study drug Peginterferon Lambda-1a
Study participants assigned to study drug will receive a single subcutaneous dose of Peginterferon Lambda-1a in addition to standard of care treatment.
Drug: Peginterferon Lambda-1a
Peginterferon Lambda-1a (180 ug subcutaneous injection) single dose along with Standard of Care
Placebo Comparator: Placebo injection
Study participants will receive a placebo along with the standard of care treatment.
Placebo subcutaneous injection along with Standard of Care Treatment for COVID-19 Infection
- Duration Until Viral Shedding Cessation [ Time Frame: Assessed for up to 28 days ]Time to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR.
- Change in Sars-CoV-2 Viral Load [ Time Frame: baseline, day 14 ]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.
- Area Under the Curve of SARS-COV-2 Viral Load [ Time Frame: baseline through day 14 ]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.
- Duration Until Resolution of Symptoms [ Time Frame: Up to 28 days ]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.
- Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331899
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Upinder Singh||Professor (Medicine-Infectious Diseases)|