Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19 (COVID-Lambda)

• 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: Stanford University
• Information provided by (Responsible Party): Stanford University

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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 (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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment [ Time Frame: 28 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Upinder Singh; Professor (Medicine-Infectious Diseases)

  Study Documents (Full-Text)

Documents provided by Stanford University:

Study Protocol and Informed Consent Form  [PDF] August 10, 2020

Statistical Analysis Plan  [PDF] September 14, 2020

More Information

Publications of Results:

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.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT04331899
• Other Study ID Numbers: 55619
• First Posted: April 2, 2020
• Results First Posted: April 22, 2021
• Last Update Posted: April 22, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Sharing of generated and analyzed datasets.
• Supporting Materials: Study Protocol; 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

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

Keywords provided by Stanford University:

Coronavirus