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
Last Update Posted : September 28, 2020
|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 24, 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 of Viral shedding of SARS-CoV-2 by qRT-PCR [ Time Frame: 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.
- Sars-CoV-2 viral load [ Time Frame: 28 days ]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: 28 days ]Area under the curve of SARSCoV-2 viral load in oropharyngeal and/or anterior nare swabs collected daily.
- Time to alleviation of all symptoms Time to alleviation of all symptoms [ Time Frame: 28 days ]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.
- Number 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)|