Covid19 Clinical Trial - Interferon Lambda for Immediate Antiviral Therapy

Status Completed

Clinical Trial Summary

Interferon lambda is one of the main arms of the innate antiviral immune response and is critical for controlling respiratory viral infections in mice. Interferon lambda has a better side effect profile than other interferons because of the limited tissue distribution of its receptor. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming its safety. We propose to evaluate peginterferon-lambda in ambulatory and hospitalized patients with mild to moderate COVID-19.

Clinical Trial Description

The study uses an adaptive design with initial enrolment in the Ambulatory cohort (Cohort A) followed by a safety assessment before initiation of enrolment in the Hospitalized cohort (Cohort B). Ambulatory patients (Cohort A) with confirmed COVID-19 deemed well enough for home isolation will be randomized to receive a single subcutaneous injection of Peginterferon lambda 180µg or saline placebo prior to discharge. Patients will be followed remotely with visits for a repeat swab at Day 3 and 7 with the primary endpoint being the proportion positive for SARS-CoV-2 on Day 7. Safety data will be reviewed by the Data Safety and Monitoring Committee after 50% of the Ambulatory cohort (n=60) has been enrolled. If the committee approves study continuation, enrolment will continue in the Ambulatory cohort (Cohort A) and will begin in the Hospitalized cohort (Cohort B). Hospitalized patients (Cohort B) with moderate but not severe COVID-19 will be enrolled and randomized to Peginterferon lambda 180µg or saline placebo on Day 0 and 5. The primary endpoint will be clinical outcomes on the WHO ordinal scale. In addition to the primary endpoint on which the study is powered, numerous secondary endpoints will be evaluated. Samples will also be collected for ancillary studies to better understand predictors of disease severity and response to treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04354259
Study type	Interventional
Source	University Health Network, Toronto
Contact
Status	Completed
Phase	Phase 2
Start date	May 13, 2020
Completion date	December 8, 2022

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT06065033` - Exercise Interventions in Post-acute Sequelae of Covid-19	N/A
Completed	`NCT06267534` - Mindfulness-based Mobile Applications Program	N/A
Completed	`NCT05047601` - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection	Phase 2/Phase 3
Recruiting	`NCT04481633` - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection	N/A
Recruiting	`NCT05323760` - Functional Capacity in Patients Post Mild COVID-19	N/A
Completed	`NCT04537949` - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults	Phase 1/Phase 2
Completed	`NCT04612972` - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru	Phase 3
Recruiting	`NCT05494424` - Cognitive Rehabilitation in Post-COVID-19 Condition	N/A
Active, not recruiting	`NCT06039449` - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2	Phase 3
Enrolling by invitation	`NCT05589376` - You and Me Healthy
Completed	`NCT05158816` - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting	`NCT04341506` - Non-contact ECG Sensor System for COVID19
Completed	`NCT04512079` - FREEDOM COVID-19 Anticoagulation Strategy	Phase 4
Completed	`NCT04384445` - Zofin (Organicell Flow) for Patients With COVID-19	Phase 1/Phase 2
Completed	`NCT05975060` - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.	Phase 2/Phase 3
Active, not recruiting	`NCT05542862` - Booster Study of SpikoGen COVID-19 Vaccine	Phase 3
Withdrawn	`NCT05621967` - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation	N/A
Terminated	`NCT05487040` - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease	Phase 1
Terminated	`NCT04498273` - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80	Phase 3
Active, not recruiting	`NCT06033560` - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms