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Interferon
Peginterferon Lambda-1A for COVID-19
Phase 3
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
Adult 18 years of age or older.
Symptomatic and within 7 days of symptom onset.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3, 5, 7, 10 and 14
Awards & highlights
Study Summary
This study is evaluating whether peginterferon-lambda can be used to treat COVID-19.
Eligible Conditions
- COVID-19
- Coronavirus
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 3, 5, 7, 10 and 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3, 5, 7, 10 and 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
COVID-19 related urgent care visit, emergency room assessment, hospitalization or death by Day 28 (Primary efficacy endpoint)
SARS-CoV-2 RNA negativity (Primary virological endpoint)
Treatment-emergent and treatment-related serious adverse events (Primary safety endpoint)
Secondary outcome measures
All symptom resolution (Clinical outcome #4)
COVID-19 in household contacts (Transmission outcome #1)
Correlation with interferon lambda 4 genotype (Virologic/immunological outcome #8)
+24 moreSide effects data
From 2018 Phase 2 trial • 33 Patients • NCT0276580286%
Headache
57%
Fatigue
50%
Dyspepsia
50%
Arthralgia
50%
Myalgia
50%
Pyrexia
36%
Nausea
36%
Diarrhea
36%
Injection site erythema
36%
Injection site pain
36%
Injection site pruritis
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%
Vomiting
14%
gamma-glutamyl transferase (GGT) increased
14%
Neutrophil count decreased
14%
Back pain
14%
Asthenia
14%
jaundice
14%
Jaundice
14%
Erythema
7%
Abdominal pain
7%
international normalized ratio (INR) increased
7%
Feeling cold
7%
Influenza like illness
7%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lambda 180 μg
Lambda 120 μg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
To receive a dose of peginterferon lambda 180mcg SC at baseline (Day 0).
Group II: PlaceboPlacebo Group1 Intervention
Patients in this arm will receive a single SC dose 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
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,464 Previous Clinical Trials
482,838 Total Patients Enrolled
27 Trials studying COVID-19
112,631 Patients Enrolled for COVID-19
Jordan Feld, MDPrincipal InvestigatorUniversity Health Network, Toronto
2 Previous Clinical Trials
172 Total Patients Enrolled
1 Trials studying COVID-19
157 Patients Enrolled for COVID-19
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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