Pegylated Interferon Lambda Treatment for COVID-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-22

Study Completion Date

2021-07-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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COVID-19 COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single blind

Study Groups

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Lambda Treatment

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

Group Type EXPERIMENTAL

Pegylated interferon lambda

Intervention Type DRUG

180 mcg subcutaneous injection of pegylated interferon lambda

Saline Placebo

Subcutaneous injection of saline placebo

Group Type PLACEBO_COMPARATOR

Pegylated interferon lambda

Intervention Type DRUG

180 mcg subcutaneous injection of pegylated interferon lambda

Interventions

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Pegylated interferon lambda

180 mcg subcutaneous injection of pegylated interferon lambda

Intervention Type DRUG

Other Intervention Names

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Lambda

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No