Back to results

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

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Peginterferon Lambda-1a

Placebo

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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:

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:
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

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study drug Peginterferon Lambda-1a

Placebo injection

Arm Description

Study participants assigned to study drug will receive a single subcutaneous dose of Peginterferon Lambda-1a in addition to standard of care treatment.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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

Full Information

NCT ID

NCT04331899

First Posted

March 27, 2020

Last Updated

November 24, 2021

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT04331899

Brief Title

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

Acronym

COVID-Lambda

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

April 25, 2020 (Actual)

Primary Completion Date

August 14, 2020 (Actual)

Study Completion Date

May 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

Coronavirus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Participant

Masking Description

Single-blind study in which only patients are blinded.

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study drug Peginterferon Lambda-1a

Arm Type

Experimental

Arm Description

Study participants assigned to study drug will receive a single subcutaneous dose of Peginterferon Lambda-1a in addition to standard of care treatment.

Arm Title

Placebo injection

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Peginterferon Lambda-1a

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Duration Until Resolution of Symptoms

Description

Time Frame

Up to 28 days

Title

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

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Received blood products within 30 days before study randomization Use of hematologic growth factors within 30 days before study randomization Systemic antibiotics, antifungals, or antivirals for treatment of active infection within 24 hours before study randomization Any prescription or herbal product that is not approved by the investigator Long-term treatment (> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor Receipt of systemic immunosuppressive therapy within 3 months before screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Upinder Singh

Organizational Affiliation

Professor (Medicine-Infectious Diseases)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://purl.stanford.edu/hc972ys6733

Citations:

PubMed Identifier

33785743

Citation

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.

Results Reference

result

PubMed Identifier

35588734

Citation

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.

Results Reference

derived

PubMed Identifier

33624010

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs