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A Phase 2 Randomized, Single Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19

Trial Profile

A Phase 2 Randomized, Single Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 22 Jun 2020

At a glance

  • Drugs Peginterferon lambda-1a (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms COVID-Lambda
  • Most Recent Events

    • 30 Apr 2020 According to an Eiger BioPharmaceuticals media release, the first patients have been dosed in this study at the Stanford University School of Medicine.
    • 23 Apr 2020 Status changed from not yet recruiting to recruiting.
    • 08 Apr 2020 New trial record

Trial Overview

Purpose

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.

Primary Endpoints

Duration of Viral shedding of SARS-CoV-2 by qRT-PCR

description: 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.
time_frame: 28 days

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 120

  • Sex male & female
  • Age Group 18-75 years; adult

Patient 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

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04331899 ClinicalTrials.gov: US National Institutes of Health
55619 -

Trial Dates

  • Initiation Dates

    Planned : 15 Apr 2020

    Actual : 24 Apr 2020

  • Primary Completion Dates

    Planned : 31 May 2021

  • End Dates

    Planned : 31 May 2022

Other Details

  • Design parallel; prospective; randomised; single-blind
  • Phase of Trial Phase II
  • Location USA
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
Peginterferon lambda-1aPrimary Drug Subcutaneous Injection

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 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)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Julie Parsonnet
6507254561
parsonnt@stanford.edu
show details
, Stanford University
-
Prasanna Jagannathan
6507245343 prasj@stanford.edu
show details
Stanford University School of Medicine USA
Upinder Singh
6507234045 usingh@stanford.edu
show details
Professor (Medicine -Infectious Diseases)
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Professor (Medicine -Infectious Diseases)
-
-
Stanford University
-
-
Stanford University School of Medicine Stanford, California USA
Stanford University School of Medicine Stanford, California USA

Trial History

Event Date Event Type Comment
22 Jun 2020 Other trial event Last checked against the ClinicalTrials.gov record. Updated 22 Jun 2020
30 Apr 2020 Other trial event According to an Eiger BioPharmaceuticals media release, the first patients have been dosed in this study at the Stanford University School of Medicine. Updated 05 May 2020
23 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 29 Apr 2020
08 Apr 2020 New trial record New trial record Updated 08 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Eiger BioPharmaceuticals. Eiger BioPharmaceuticals Announces First COVID-19 Patients Dosed with Peginterferon Lambda. Media-Rel 2020;.

    Media Release
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