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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Peginterferon Lambda-1a; Other: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration Until Viral Shedding Cessation	Time to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR.	Assessed for up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sars-CoV-2 Viral Load	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.	baseline, day 14
Area Under the Curve of SARS-COV-2 Viral Load	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.	baseline through day 14
Duration Until Resolution of Symptoms	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.	Up to 28 days
Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment		28 days

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Upinder Singh, Professor (Medicine-Infectious Diseases)

Publications and helpful links

General 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.
• van der Ploeg K, Kirosingh AS, Mori DAM, Chakraborty S, Hu Z, Sievers BL, Jacobson KB, Bonilla H, Parsonnet J, Andrews JR, Press KD, Ty MC, Ruiz-Betancourt DR, de la Parte L, Tan GS, Blish CA, Takahashi S, Rodriguez-Barraquer I, Greenhouse B, Singh U, Wang TT, Jagannathan P. TNF-alpha+ CD4+ T cells dominate the SARS-CoV-2 specific T cell response in COVID-19 outpatients and are associated with durable antibodies. Cell Rep Med. 2022 Jun 21;3(6):100640. doi: 10.1016/j.xcrm.2022.100640. Epub 2022 May 3.
• Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2020
• Primary Completion (ACTUAL): August 14, 2020
• Study Completion (ACTUAL): May 6, 2021

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (ACTUAL): April 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Coronavirus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 55619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing of generated and analyzed datasets.
• IPD Sharing Time Frame: The datasets generated and analyzed during the current study are permanently available in the Stanford Digital Repository
• IPD Sharing Access Criteria: Full access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No