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 : Recruiting
First Posted : April 2, 2020
Last Update Posted : April 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Peginterferon Lambda-1a Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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 Compared With Placebo in Outpatients With Mild COVID-19|
|Actual Study Start Date :||April 24, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2022|
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 nasopharyngeal and/or oropharyngeal and/or salivary swabs tests for SARS-CoV-2 by qRT-PCR.
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
|Contact: Upinder Singhfirstname.lastname@example.org|
|Contact: Julie Parsonnetemail@example.com|
|Principal Investigator:||Upinder Singh||Professor (Medicine -Infectious Diseases)|