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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 24 May 2021

At a glance

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

    • 19 May 2021 Status changed from active, no longer recruiting to completed.
    • 28 Sep 2020 Results presented in an Eiger BioPharmaceuticals media release.
    • 24 Sep 2020 Planned End Date changed from 31 May 2022 to 1 May 2021.

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 Until Viral Shedding Cessation

description: Time to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR.
time_frame: Assessed for up to 28 days

Other Endpoints

Change in Sars-CoV-2 Viral Load

description: 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.
time_frame: baseline, day 14

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

description: 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.
time_frame: baseline through day 14

Duration Until Resolution of Symptoms

description: 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.
time_frame: Up to 28 days

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

time_frame: 28 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 120

    Actual: 120

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

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 -

Organisations

  • Affiliations Eiger BioPharmaceuticals

Trial Dates

  • Initiation Dates

    Planned : 15 Apr 2020

    Actual : 25 Apr 2020

  • Primary Completion Dates

    Planned : 31 May 2021

    Actual : 14 Aug 2020

  • End Dates

    Planned : 01 May 2021

    Actual : 06 May 2021

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)

Results

Therapeutic efficacy

In a phase II trial, treatment with peginterferon lambda-1a reported no difference in the duration of COVID-2019 viral shedding and time to symptom resolution when compared with placebo [2] .

Adverse events

In a phase II trial, treatment with peginterferon lambda-1a was well-tolerated in patients with COVID-2019 infections. Few adverse events were reported which included elevated transaminases which was self-resolved [2] .

Publications

  1. Eiger BioPharmaceuticals, Inc. Eiger Announces Results of Investigator Sponsored Study in Outpatients with Mild and Uncomplicated COVID-19. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Eiger BioPharmaceuticals, Inc. 1 1 1

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
24 May 2021 Other trial event Last checked against the ClinicalTrials.gov record. Updated 24 May 2021
19 May 2021 Status change - completed Status changed from active, no longer recruiting to completed. Updated 24 May 2021
28 Sep 2020 Results Results presented in an Eiger BioPharmaceuticals media release. Updated 30 Sep 2020
24 Sep 2020 Completion date Planned End Date changed from 31 May 2022 to 1 May 2021. Updated 07 Oct 2020
24 Sep 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 07 Oct 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 2021;.

    Available from: URL: http://clinicaltrials.gov
  2. Eiger BioPharmaceuticals, Inc. Eiger Announces Results of Investigator Sponsored Study in Outpatients with Mild and Uncomplicated COVID-19. Media-Rel 2020;.

    Media Release
  3. Eiger BioPharmaceuticals. Eiger BioPharmaceuticals Announces First COVID-19 Patients Dosed with Peginterferon Lambda. Media-Rel 2020;.

    Media Release
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