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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

Tracking Information
First Submitted Date  ICMJE March 27, 2020
First Posted Date  ICMJE April 2, 2020
Results First Submitted Date  ICMJE April 8, 2021
Results First Posted Date  ICMJE April 22, 2021
Last Update Posted Date April 22, 2021
Actual Study Start Date  ICMJE April 25, 2020
Actual Primary Completion Date August 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2021)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19
Official Title  ICMJE 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
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.
Detailed Description Patients will attend up to 9 study visits over a period of up to 28 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Peginterferon Lambda-1a
    Peginterferon Lambda-1a (180 ug subcutaneous injection) single dose along with Standard of Care
  • Other: Placebo
    Placebo subcutaneous injection along with Standard of Care Treatment for COVID-19 Infection
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Peginterferon Lambda-1a
  • Placebo Comparator: Placebo injection
    Study participants will receive a placebo along with the standard of care treatment.
    Intervention: Other: Placebo
Publications * Jagannathan P, Andrews JR, Bonilla H, Hedlin H, Jacobson KB, Balasubramanian V, Purington N, Kamble S, de Vries CR, Quintero O, Feng K, Ley C, Winslow D, Newberry J, Edwards K, Hislop C, Choong I, Maldonado Y, Glenn J, Bhatt A, Blish C, Wang T, Khosla C, Pinsky BA, Desai M, Parsonnet J, Singh U. Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial. Nat Commun. 2021 Mar 30;12(1):1967. doi: 10.1038/s41467-021-22177-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 1, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Actual Primary Completion Date August 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 75 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. Diagnosis of COVID-19 disease:

    1. If symptomatic, the presence of mild to moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours from swab to the time of commencing informed consent:
    2. If asymptomatic, initial diagnosis of SARS-CoV-2 infection with positive FDA-cleared molecular diagnostic assay obtained no more than 72 hours from initial swab to the time of commencing informed consent

Exclusion Criteria:

  1. Patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent
  2. Patients with a known allergy to Peginterferon Lambda-1a or any component thereof
  3. Display symptoms of respiratory distress (Respiratory rate >20, room air oxygen saturation of <94%.)
  4. Participation in a clinical trial with or use of any investigational agent within 30 days before screening
  5. Treatment with interferons (IFN) within 12 months before screening
  6. Previous use of Peginterferon Lambda-1a
  7. History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.
  8. Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.
  9. Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma
  10. Co-infected with human immunodeficiency virus (HIV)
  11. Significant abnormal laboratory test results at screening.
  12. Other significant medical condition that may require intervention during the study
  13. 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 24 hours 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
    8. Receipt of systemic immunosuppressive therapy within 3 months before screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04331899
Other Study ID Numbers  ICMJE 55619
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Sharing of generated and analyzed datasets.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: The datasets generated and analyzed during the current study are permanently available in the Stanford Digital Repository
Access Criteria: Full access
URL: https://purl.stanford.edu/hc972ys6733
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Upinder Singh Professor (Medicine-Infectious Diseases)
PRS Account Stanford University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP