Clinical trial NCT04343976: Pegylated Interferon Lambda Treatment for COVID-19
Official title: A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
COVID
Keywords: COVID
Coronavirus
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Eiger BioPharmaceuticals
First posted: 2020-04-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The study objective is to assess the efficacy of Pegylated Interferon Lambda (180 mcg) vs. placebo in inducting quantitative PCR negativity at day 7

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Known hypersensitivity to Interferons
* Current or planned participation in an investigational new drug (IND) trial from 30-days prior to randomization through Day 14 post treatment

Primary outcomes:
measure: Undetectable COVID PCR at Day 7
timeFrame: 7 days
Secondary outcomes:
measure: Undetectable COVID PCR at Day 3
timeFrame: 3 days
measure: Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement
timeFrame: 2 weeks
measure: Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes
timeFrame: 2 weeks
measure: Undetectable COVID PCR Testing at Day 14
timeFrame: 14 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Raymond Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.