NCT04388709

Interferon Lambda Therapy for COVID-19

A Randomized Phase 2 Trial of Peginterferon Lambda-1a (Lambda) for the Treatment of Hospitalized Patients Infected With SARS-CoV-2 With Non-critical Illness

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this research study is to test the safety and effectiveness of an investigational drug peginterferon lambda-1a in treating COVID-19.

Detailed description

Primary Objective: Determine efficacy of pegylated interferon lambda as measured by clinical improvement. This will be defined as improvement in supplemental oxygen requirement. Secondary Objectives: * Determine safety and tolerability of pegylated interferon lambda * Days with fever * Time to resolution of fever * Rate of progression to requiring critical care * Overall survival * Time to discharge Exploratory Objectives: Determining the effect systemically on inflammatory markers in the blood, as well as viral load. Diagnosis and Main Inclusion Criteria: Patients must have a confirmed diagnosis of infection with SARS-CoV-2 and be receiving supplemental oxygen. Many patients may be receiving hydroxychloroquine with or without other antimicrobials.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	Peginterferon Lambda-1A	Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-02-05
• Completion: 2021-02-05
• First posted: 2020-05-14
• Last updated: 2021-02-26

Regulatory

• FDA-regulated drug study