Overview
Pegylated Interferon Lambda Treatment for COVID-19
Status:
Terminated
Terminated
Trial end date:
2021-07-30
2021-07-30
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Raymond ChungCollaborator:
Eiger BioPharmaceuticalsTreatments:
Interferons
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