Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19

PHASE2CompletedINTERVENTIONAL
Enrollment

157

Participants

Timeline

Start Date

May 13, 2020

Primary Completion Date

August 19, 2022

Study Completion Date

December 8, 2022

Conditions
Sars-CoV2Covid-19
Interventions
DRUG

Peginterferon Lambda-1A

Peginterferon lambda is a covalent conjugate of human recombinant non-pegylated IFN lambda (IFN L) and a 20-kDa linear PEG chain. Peginterferon lambda Injection is a sterile, nonpyrogenic, ready-to-use solution (0.4 mg/mL) that is clear to opalescent, colorless to pale yellow, and essentially free of particles. Lambda Injection is provided in a 1-mL long Type I glass syringe (0.18 mg/syringe) with a staked 29-gauge, 1/2- inch, thin-walled needle. The syringe has a rigid needle shield and is stoppered with a plunger stopper. Syringes are prefilled with a solution of Peginterferon lambda Injection, mannitol, L-histidine, polysorbate 80, hydrochloric acid, and water for injection; they are intended for a single use at adjustable doses. The syringe is marked with dose indicator lines, which are used as a reference point for administering the correct dose.

OTHER

placebo

injection of 0.9% sodium chloride (normal saline) solution. A plastic 1 mL syringe will be prefilled by the study pharmacy. Each syringe will contain 0.5 mL (0.45 mL to match the volume of the Interferon plus 0.05 mL overfill) to allow for needle priming by the unblinded study nurse.

Trial Locations (7)

Unknown

Hospital das Clínicas da Faculdade de Medicina de Botucatu, Botucatu

Hospital Alemão Oswaldo Cruz, São Paulo

Hospital das Clínicas São Paulo, São Paulo

T2N 2T9

University of Calgary, Calgary

M4C 3E7

Michael Garron Hospital, Toronto

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2C4

University Health Network, Toronto

All Listed Sponsors
collaborator

Michael Garron Hospital

OTHER

lead

University Health Network, Toronto

OTHER

NCT04354259 - Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19 | Biotech Hunter | Biotech Hunter