Unable to meet enrollment goal, lack of funding.

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.

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

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

Coded data is anticipated to be shared with outside institutions. Safety data will be shared with the drug manufacturer

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

researchers accessing IPD must be an approved and have a data use agreement in place with Partners Healthcare to access the data

Adverse event data was collect beginning at time of consent (day 0) through study completion (day 14). Total period of 2 weeks.

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.

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