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

• ClinicalTrials.gov Identifier: NCT04331899
• Recruitment Status: Recruiting
• First Posted: April 2, 2020
• Last Update Posted: April 27, 2020
• Sponsor: Stanford University
• Information provided by (Responsible Party): Upinder Singh, Stanford University

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.

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: Peginterferon Lambda-1a; Other: Placebo	Phase 2

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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: Single (Participant)
• Masking Description: Single-blind study in which only patients are blinded.
• Primary Purpose: Treatment
• Official Title: A Phase 2 Randomized, Single Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19
• Actual Study Start Date: April 24, 2020
• Estimated Primary Completion Date: May 31, 2021
• Estimated Study Completion Date: May 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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 Comparator: 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

Outcome Measures

Primary Outcome Measures :

1. Duration of Viral shedding of SARS-CoV-2 by qRT-PCR [ Time Frame: 28 days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 64 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. Initial diagnosis of COVID-19 disease as defined by a FDA-cleared molecular diagnostic assay positive for SARS-CoV-2
4. Display symptoms of COVID respiratory infection without respiratory distress

Exclusion Criteria:

• Patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent

  1. Patients with a known allergy to Peginterferon Lambda-1a or any component thereof
  2. Room air oxygen saturation of <94%
  3. Participation in a clinical trial with or use of any investigational agent within 30 days before screening, or treatment with interferons (IFN) or immunomodulators within 12 months before screening
  4. Previous use of Peginterferon Lambda-1a
  5. History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.
  6. Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.
  7. Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma
  8. Co-infected with human immunodeficiency virus (HIV).
  9. Significant abnormal laboratory test results at screening.
  10. Significant concurrent illnesses and other comorbidities that may require intervention during the study

  11. 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 14 days 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

Contacts and Locations

Contacts

Contact: Upinder Singh; 6507234045; usingh@stanford.edu

Contact: Julie Parsonnet; 6507254561; parsonnt@stanford.edu

Locations

United States, California

Stanford University School of Medicine; Recruiting

Stanford, California, United States, 94305

Contact: Savita Kamble 650-736-7388 skamble@stanford.edu

Contact: Prasanna Jagannathan 6507245343 prasj@stanford.edu

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Upinder Singh; Professor (Medicine -Infectious Diseases)

More Information

• Responsible Party: Upinder Singh, Professor (Medicine -Infectious Diseases), Stanford University
• ClinicalTrials.gov Identifier: NCT04331899
• Other Study ID Numbers: 55619
• First Posted: April 2, 2020
• Last Update Posted: April 27, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No current plan to share the data.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No