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Interferon

Peginterferon Lambda-1A for Coronavirus (ILIAD Trial)

Phase 2

Waitlist Available

Led By Jordan Feld, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 0-7, 10, 12, 14, 18, 21, 25 and 28

Awards & highlights

ILIAD Trial Summary

This trial will test a long-acting form of interferon lambda to see if it is safe and effective in treating mild to moderate COVID-19.

Eligible Conditions

Coronavirus
COVID-19

ILIAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 0-7, 10, 12, 14, 18, 21, 25 and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 0-7, 10, 12, 14, 18, 21, 25 and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0-7, 10, 12, 14, 18, 21, 25 and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cohort A (Ambulatory) - Proportion swab negative at day 7 (Primary efficacy endpoint)

Cohort A (Ambulatory) - Treatment-emergent and treatment related serious adverse events (Primary Safety Endpoint)

Cohort B (Hospitalized) - Ordinal Scale (Primary Efficacy Endpoint)

+1 more

Secondary outcome measures

Cohort A (Ambulatory) - Adverse and serious adverse events (Clinical Outcome #4)

Cohort A (Ambulatory) - COVID-19 in household contacts (Transmission Outcome #2)

Cohort A (Ambulatory) - Correlation with interferon lambda 4 genotype (Virologic/Immunological Outcome #5)

+39 more

Side effects data

From 2018 Phase 2 trial • 33 Patients • NCT02765802

86%

Headache

57%

Fatigue

50%

Pyrexia

50%

Dyspepsia

50%

Arthralgia

50%

Myalgia

36%

Diarrhea

36%

Nausea

36%

Injection site pain

36%

Injection site pruritis

36%

Injection site erythema

36%

Alanine Aminotransferase (ALT) increase

36%

Aspartate Aminotransferase (AST) Increase

29%

Pruritis

29%

Blood bilirubin increased

21%

Abdominal pain upper

21%

Dizziness

21%

Dysgeusia

21%

Rhinorrhea

21%

Chills

14%

Erythema

14%

Vomiting

14%

jaundice

14%

gamma-glutamyl transferase (GGT) increased

14%

Neutrophil count decreased

14%

Back pain

14%

Asthenia

14%

Jaundice

Abdominal pain

international normalized ratio (INR) increased

Feeling cold

Influenza like illness

Oropharyngeal pain

100%

80%

60%

40%

20%

Study treatment Arm

Lambda 180 μg

Lambda 120 μg

ILIAD Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Hospitalized Cohort - TreatmentExperimental Treatment1 Intervention

To receive a dose of peginterferon lambda 180µg SC at baseline and a second dose on day 5.

Group II: Ambulatory Cohort - TreatmentExperimental Treatment1 Intervention

to receive a single dose of peginterferon lambda 180µg SC at baseline (day 0).

Group III: Hospitalized Cohort - placeboPlacebo Group1 Intervention

Patients in the arm will be given an injection of 0.9% sodium chloride (normal saline) solution at baseline (day 0). 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. Patients will be administered a second dose of placebo on day 5.

Group IV: Ambulatory Cohort - placeboPlacebo Group1 Intervention

Patients in the arm will be given a single injection of 0.9% sodium chloride (normal saline) solution at baseline (day 0). 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peginterferon Lambda-1A

2020

Completed Phase 2

~190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,362 Total Patients Enrolled

Michael Garron HospitalOTHER

13 Previous Clinical Trials

4,555 Total Patients Enrolled

Jordan Feld, MDPrincipal InvestigatorUniversity Health Network, Toronto

2 Previous Clinical Trials

778 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Peginterferon Lambda-1A been cleared by the FDA?

"Peginterferon Lambda-1A falls into Phase 2 of medical trials. This means that while there is evidence suggesting it is safe, there is currently no data to support its efficacy."

Answered by AI

What goals does this research hope to reach?

"The primary objective of this study, which will be conducted over the course of 7 days, is to measure the rate of serious adverse events in relation to the treatment. Additionally, we hope to gain insights into secondary objectives including antibody response rates and length of hospital stay."

Answered by AI

What are some previous cases in which Peginterferon Lambda-1A has been tested?

"The first clinical trial for Peginterferon Lambda-1A was conducted in 2020 at Soroka UMC. At the time of writing this, there are 2698 completed trials and 4 ongoing studies. Most active research is being conducted out of Calgary, Alberta."

Answered by AI

How many people are chosen to participate in this investigation?

"From the clinicaltrials.gov site, it appears that this study is open and looking for patients. The trial began on May 13th 2020 and was most recently updated on January 17th 2022. There are 4 locations enrolling a total of 240 individuals."

Answered by AI

Can new participants still join this experiment?

"From what is indicated on clinicaltrials.gov, it seems that the trial is still looking for participants. The initial posting was on 5/13/2020 with the most recent update being 1/17/2022. There is a need for 240 patients total from 4 different locations."

Answered by AI

Recent research and studies

Nature Reviews ImmunologyJournal

The Type I Interferon Response in COVID-19: Implications for Treatment

Lee, Jeong Seok, and Eui-Cheol Shin. 2020. “The Type I Interferon Response in COVID-19: Implications for Treatment”. Nature Reviews Immunology. Springer Science and Business Media LLC. doi:10.1038/s41577-020-00429-3.

Nature Reviews Gastroenterology & HepatologyJournal

IBD in the Time of Corona — Vigilance for Immune-mediated Diseases

Moschen, Alexander R.. 2020. “IBD in the Time of Corona — Vigilance for Immune-mediated Diseases”. Nature Reviews Gastroenterology & Hepatology. Springer Science and Business Media LLC. doi:10.1038/s41575-020-0333-5.

The Lancet Respiratory MedicineJournal

Peginterferon Lambda for the Treatment of Outpatients with COVID-19: A Phase 2, Placebo-controlled Randomised Trial

Feld, Jordan J, Christopher Kandel, Mia J Biondi, Robert A Kozak, Muhammad Atif Zahoor, Camille Lemieux, Sergio M Borgia, et al.. 2021. “Peginterferon Lambda for the Treatment of Outpatients with COVID-19: A Phase 2, Placebo-controlled Randomised Trial”. The Lancet Respiratory Medicine. Elsevier BV. doi:10.1016/s2213-2600(20)30566-x.

Nature Reviews ImmunologyJournal