Status:
TERMINATED
Pegylated Interferon Lambda Treatment for COVID-19
Lead Sponsor:
Raymond Chung
Collaborating Sponsors:
Eiger BioPharmaceuticals
Conditions:
COVID-19
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04343976
Start Date
June 22 2020
End Date
July 30 2021
Last Update
July 21 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114