Pegylated Interferon Lambda Treatment for COVID-19

NCT04343976 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2020P001083
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective randomized trial to assess the antiviral efficacy of Pegylated Interferon Lambda (180 mcg SC injection) vs.placebo in up to 20 subjects with COVID-19 infection.

Conditions

COVID-19; COVID

Keywords

COVID; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Undetectable COVID PCR at Day 7

  Negative COVID PCR testing 7 days after first lambda dose

  7 days

Secondary Outcomes (4)

• Undetectable COVID PCR at Day 3

  3 days

• Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement

  2 weeks

• Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes

  2 weeks

• Undetectable COVID PCR Testing at Day 14

  14 days

Study Arms (2)

Lambda Treatment

EXPERIMENTAL

Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda

Drug: Pegylated interferon lambda

Saline Placebo

PLACEBO COMPARATOR

Subcutaneous injection of saline placebo

Drug: Pegylated interferon lambda

Interventions

Pegylated interferon lambda DRUG

180 mcg subcutaneous injection of pegylated interferon lambda

Also known as: Lambda

Lambda Treatment; Saline Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent
• Confirmed COVID-19 diagnosis based on PCR analysis of respiratory secretions
• Positive SARS-CoV-2 RT-PCR test must be within 48 hours of randomization

You may not qualify if:

• Clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol
• Treatment with IFN or other immunomodulatory/immunosuppressive agent within 12 months before screening.
• Respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation)
• History of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-IL-6, anti-IL6R antagonists, Janus kinase inhibitors, ustekinumab (anti-IL-12/23), or anti IL-23 agents (guselkumab).
• Life threatening SAE during the screening period
• Pregnant or Nursing Females
• Platelet count \<90,000 cells/mm3
• WBC count \<3,000 cells/mm3
• ANC \<1,500 cells/mm3
• Hb \<11 g/dL for women and \<12 g/dL for men
• CrCl \< 50 mL/min
• Bilirubin level ≥ 1.5x ULN
• INR ≥1.5 (except in the setting of concomitant anticoagulant use)
• CRP \> 200 mg/L
• Clinically-relevant alcohol or drug abuse within 12 months of screening

Sponsors & Collaborators

• Raymond Chung: lead
• Eiger BioPharmaceuticals: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Lee JS, Shin EC. The type I interferon response in COVID-19: implications for treatment. Nat Rev Immunol. 2020 Oct;20(10):585-586. doi: 10.1038/s41577-020-00429-3.

  PMID: 32788708 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Enrollment was slower than anticipated due to issues operationalizing outpatient follow-up for viremic subjects discharged from hospital prior to study completion, including lack of transportation and delays contracting with home health services to offer home visits. Also, study was terminated prior to meeting enrollment goal due to a decrease in eligible subjects and lack of funding.

Results Point of Contact

• Title: Sponsor-Investigator
• Organization: Massachusetts General Hospital

chung.raymond@mgh.harvard.edu

617-724-3836

Study Officials

• Raymond Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Hepatology, MGH

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: June 22, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: July 21, 2022
• Results First Posted: July 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data is anticiapted to be made available within 3 months of study completion. Safety data, specifically treatment related adverse events, will be shared in real time
• Access Criteria: researchers accessing IPD must be an approved and have a data use agreement in place with Partners Healthcare to access the data

Locations

US (1)