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

NCT04331899 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 55619
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Coronavirus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Sars-CoV-2 Viral Load

  baseline, day 14

• Area Under the Curve of SARS-COV-2 Viral Load

  baseline through day 14

• Duration Until Resolution of Symptoms

  Up to 28 days

• Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment

  28 days

Study Arms (2)

Study drug Peginterferon Lambda-1a

EXPERIMENTAL

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

Placebo injection

PLACEBO COMPARATOR

Study participants will receive a placebo along with the standard of care treatment.

Other: Placebo

Interventions

Peginterferon Lambda-1a DRUG

Peginterferon Lambda-1a (180 ug subcutaneous injection) single dose along with Standard of Care

Study drug Peginterferon Lambda-1a

Placebo OTHER

Placebo subcutaneous injection along with Standard of Care Treatment for COVID-19 Infection

Placebo injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 75 years at the time of the assessment
• Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
• Diagnosis of COVID-19 disease:
• 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:
• 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

You may not qualify if:

• Patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent
• Patients with a known allergy to Peginterferon Lambda-1a or any component thereof
• Display symptoms of respiratory distress (Respiratory rate \>20, room air oxygen saturation of \<94%.)
• Participation in a clinical trial with or use of any investigational agent within 30 days before screening
• Treatment with interferons (IFN) within 12 months before screening
• Previous use of Peginterferon Lambda-1a
• History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.
• Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.
• Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma
• Co-infected with human immunodeficiency virus (HIV)
• Significant abnormal laboratory test results at screening.
• Other significant medical condition that may require intervention during the study
• Concurrent use of any of the following medications:
• Therapy with an immunomodulatory agent
• Current use of heparin or Coumadin

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (4)

• 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.

  PMID: 33785743 RESULT

• McCarthy MW. Interferon lambda as a potential treatment for COVID-19. Expert Opin Biol Ther. 2023 May;23(5):389-394. doi: 10.1080/14712598.2023.2211709. Epub 2023 May 8.

  PMID: 37147857 DERIVED

• 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.

  PMID: 35588734 DERIVED

• 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.

  PMID: 33624010 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

peginterferon lambda-1a

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Prasanna Jagannathan, MD
• Organization: Stanford University

prasj@stanford.edu

1-650-724-5343

Study Officials

• Upinder Singh

  Professor (Medicine-Infectious Diseases)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind study in which only patients are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 2, 2020
• Study Start: April 25, 2020
• Primary Completion: August 14, 2020
• Study Completion: May 6, 2021
• Last Updated: November 30, 2021
• Results First Posted: April 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The datasets generated and analyzed during the current study are permanently available in the Stanford Digital Repository
• Access Criteria: Full access

Locations

US (1)