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

NCT ID: NCT04331899

Last Updated: 2021-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-25

Study Completion Date

2021-05-06

Brief Summary

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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

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

Conditions

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COVID-19

Keywords

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Coronavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single-blind study in which only patients are blinded.

Study Groups

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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.

Group Type EXPERIMENTAL

Peginterferon Lambda-1a

Intervention Type DRUG

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

Placebo injection

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Peginterferon Lambda-1a

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Upinder Singh

Role: PRINCIPAL_INVESTIGATOR

Professor (Medicine-Infectious Diseases)

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 33785743 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37147857 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35588734 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33624010 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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55619

Identifier Type: -

Identifier Source: org_study_id