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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)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331899
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Upinder Singh, Stanford University

Brief Summary:
To evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of Peginterferon Lambda-1a, compared with placebo in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Peginterferon Lambda-1a Other: Placebo Phase 2

Detailed Description:
Patients will attend up to 9 study visits over a period of up to 28 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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: Single (Participant)
Masking Description: Single-blind study in which only patients are blinded.
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Other: Placebo
Placebo subcutaneous injection along with Standard of Care Treatment for COVID-19 Infection




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 64 years at the time of the assessment
  2. Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
  3. Initial diagnosis of COVID-19 disease as defined by a FDA-cleared molecular diagnostic assay positive for SARS-CoV-2
  4. Display symptoms of COVID respiratory infection without respiratory distress

Exclusion Criteria:

  • Patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent

    1. Patients with a known allergy to Peginterferon Lambda-1a or any component thereof
    2. Room air oxygen saturation of <94%
    3. Participation in a clinical trial with or use of any investigational agent within 30 days before screening, or treatment with interferons (IFN) or immunomodulators within 12 months before screening
    4. Previous use of Peginterferon Lambda-1a
    5. History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.
    6. Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.
    7. Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma
    8. Co-infected with human immunodeficiency virus (HIV).
    9. Significant abnormal laboratory test results at screening.
    10. Significant concurrent illnesses and other comorbidities that may require intervention during the study
    11. Concurrent use of any of the following medications:

      1. Therapy with an immunomodulatory agent
      2. Current use of heparin or Coumadin
      3. Received blood products within 30 days before study randomization
      4. Use of hematologic growth factors within 30 days before study randomization
      5. Systemic antibiotics, antifungals, or antivirals for treatment of active infection within 14 days before study randomization
      6. Any prescription or herbal product that is not approved by the investigator
      7. Long-term treatment (> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor

Information from the National Library of Medicine

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


Contacts
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Contact: Upinder Singh 6507234045 usingh@stanford.edu
Contact: Julie Parsonnet 6507254561 parsonnt@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Savita Kamble    650-736-7388    skamble@stanford.edu   
Contact: Prasanna Jagannathan    6507245343    prasj@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Upinder Singh Professor (Medicine -Infectious Diseases)
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Responsible Party: Upinder Singh, Professor (Medicine -Infectious Diseases), Stanford University
ClinicalTrials.gov Identifier: NCT04331899    
Other Study ID Numbers: 55619
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share the data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No