NCT04534673

Pegylated Interferon Lambda for Treatment of COVID-19 Infection

Pegylated Interferon Lambda for Treatment of COVID-19 Infection- A Randomized Open Label Pilot Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized, open-label, 2 arm, pilot trial of Lambda 180 mcg administered subcutaneously once weekly, for up to two weeks (2 injections at most), in addition to standard supportive care, compared to standard supportive care alone, in a population of COVID-19 infected patients. patients will be randomized according to 1:1 ratio to one of the 2 trial arms: Lambda 180 mcg S.C + standard care (intervention arm) or standard care only (control arm).

Detailed description

Recently, a novel coronavirus (SARS-CoV-2) has been identified as the causative pathogen of a rapidly spreading infection associated with pneumonia and severe acute respiratory syndrome (COVID-19), for which there is currently no approved therapy. Interferon Lambda (IFN Lambda) is a type III interferon with broad anti-viral activity and receptor distribution limited to the respiratory and gastrointestinal epithelium. Studies in animal models suggest that IFN Lambda may ameliorate infection with respiratory viruses such as influenza coronaviruses. The WHO has recently included pegylated interferon lambda in its landscape analysis of potential therapeutics for COVID-19. In this randomized, open-label, 2 arms, pilot trial, up to 40 patients diagnosed with COVID-19 and mild to moderate respiratory infection, will be randomized to one of 2 treatment arms in 1:1 ratio: 1. Lambda 180 mcg administered S.C once weekly, for up to two weeks (2 injections at most) + standard care, Or 2. Standard care alone. Efficacy of Lambda will be assessed by PCR analysis for COVID-19 (Fluxergy, Irvine CA), from respiratory secretions obtained by nasopharyngeal and oropharyngeal swabs, collected consecutively at day 1, 3, 5, 7, 10, 14 and 21 following initial diagnosis or until patients are discharged following achievement of two consecutive PCR negative tests for COVID-19. Safety and tolerability of Lambda will be assessed by adverse event (AE) monitoring, vital signs assessment and clinical laboratory tests (CBC, and extended chemistry panel).

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Lambda 180 mcg S.C	Prefilled injection syringe of 180 microgram Pegylated interferon lambda, administered on day 0 and if needed on day 7

Timeline

• Start date: 2020-04-07
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2020-09-01
• Last updated: 2023-05-06

Locations

1 site across 1 country: Israel