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Peginterferon Lambda-1A for Coronavirus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Coronavirus+1 MorePeginterferon Lambda-1A - Drug
Eligibility
18+
All Sexes
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Study 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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Active Arm, Zota Cohort 2
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Study Objectives

4 Primary · 42 Secondary · Reporting Duration: Days 0-7, 10, 12, 14, 18, 21, 25 and 28

At Day 14
Cohort B (Hospitalized) - Ordinal Scale (Primary Efficacy Endpoint)
At Day 3
Cohort A (Ambulatory) - Swab negative at day 3 (Virologic/Immunological Outcome #1)
At Day 30
Cohort A (Ambulatory) - COVID-19 in household contacts (Transmission Outcome #2)
Day 7
Cohort B (Hospitalized) - Proportion with Antibody (Virologic/Immunological) Outcome #20)
Day 7
Cohort B (Hospitalized) - Ordinal scale (Clinical Outcome #1)
At day 28
Cohort B (Hospitalized) - COVID-19-related mortality (Clinical Outcome #8)
Day 90
Cohort B (Hospitalized) - All-cause mortality (Clinical Outcome #6)
At day 7
Cohort A (Ambulatory) - Proportion swab negative at day 7 (Primary efficacy endpoint)
Day 28
Cohort B (Hospitalized) - Quantitative viral load by nasal swab (Virologic/Immunological Outcome #3)
Cohort B (Hospitalized) - Time to viral negativity (Virologic/Immunological Outcome #1)
Day 7
Cohort A (Ambulatory) - Proportion viremic (Virologic/Immunological Outcome #3)
Cohort A (Ambulatory) - Proportion with antibodies (Virologic/Immunological Outcome #4)
Day 0
Cohort B (Hospitalized) - Change in respiratory symptom score (Clinical Outcome #5)
Day 14
Cohort A (Ambulatory) - Adverse and serious adverse events (Clinical Outcome #4)
Cohort A (Ambulatory) - Hospitalization (Clinical Outcome #3)
Cohort A (Ambulatory) - Symptom Resolution (Clinical Outcome #1)
Cohort A (Ambulatory) - Symptoms in household contacts (Transmission Outcome #1)
Cohort A (Ambulatory) - Time RNA negativity (Virologic/Immunological Outcome #2)
Cohort B (Hospitalized) - Length of hospital stay (Clinical Outcome #4)
Day 28
Cohort B (Hospitalized) - Need for intubation (Clinical Outcome #3)
Day 28
Cohort A (Ambulatory) - Treatment-emergent and treatment related serious adverse events (Primary Safety Endpoint)
Cohort B (Hospitalized) - treatment-emergent and treatment-related serious adverse events (Primary Safety Endpoint)
Day 7
Cohort A (Ambulatory) - Symptom severity scores (Clinical Outcome #2)
Day 28
Cohort B (Hospitalized) - Adverse (AEs) and Serious Adverse Events (SAEs) (Clinical Outcome #9)
Cohort B (Hospitalized) - ICU admission (Clinical Outcome #2)
Day 7
Cohort B (Hospitalized) - Proportion with viremia (Virologic/Immunological Outcome #21)
Day 9
Cohort B (Hospitalized) - Dose reduction or dose omission (Clinical Outcome #10)
Day 0
Cohort B (Hospitalized) - Proportion negative swab. (Virologic/Immunological Outcome #2)
Day 14
Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #14)
Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #15)
Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #16)
Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #17)
Tumor Markers
Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #19)
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #10)
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #11)
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #12)
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #13)
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #5)
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #6)
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #7)
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #8)
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #9)
Day 0
Cohort B (Hospitalized) - Readmission to hospital (Clinical Outcome #7)
Through Day 14
Cohort B (Hospitalized) - Correlation with interferon lambda 4 (IFNL4) genotype (Virologic/Immunological Outcome #4)
Through day 7
Cohort A (Ambulatory) - Correlation with interferon lambda 4 genotype (Virologic/Immunological Outcome #5)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Side Effects for

Lambda 120 μg
47%Headache
42%Pyrexia
42%Arthralgia
32%Dyspepsia
26%Back pain
26%Myalgia
26%Diarrhea
26%Chills
21%Influenza like illness
21%Jaundice
21%jaundice
21%Decreased appetite
16%Urinary tract infection
16%Alanine Aminotransferase (ALT) increase
16%Vomiting
16%Fatigue
11%Blood bilirubin increased
11%gamma-glutamyl transferase (GGT) increased
11%Abdominal pain upper
11%Erythema
11%Feeling cold
11%Oropharyngeal pain
11%Injection site pruritis
11%Aspartate Aminotransferase (AST) Increase
11%international normalized ratio (INR) increased
11%Abdominal pain
5%Dizziness
5%Neutrophil count decreased
5%Pruritis
5%Nausea
5%Injection site pain
5%Drug-Induced Liver Injury (DILI)
5%Asthenia
5%Injection site erythema
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02765802) in the Lambda 120 μg ARM group. Side effects include: Headache with 47%, Pyrexia with 42%, Arthralgia with 42%, Dyspepsia with 32%, Back pain with 26%.

Trial Design

4 Treatment Groups

Hospitalized Cohort - Treatment
1 of 4
Ambulatory Cohort - Treatment
1 of 4
Hospitalized Cohort - placebo
1 of 4
Ambulatory Cohort - placebo
1 of 4

Experimental Treatment

Non-Treatment Group

240 Total Participants · 4 Treatment Groups

Primary Treatment: Peginterferon Lambda-1A · Has Placebo Group · Phase 2

Hospitalized Cohort - Treatment
Drug
Experimental Group · 1 Intervention: Peginterferon Lambda-1A · Intervention Types: Drug
Ambulatory Cohort - Treatment
Drug
Experimental Group · 1 Intervention: Peginterferon Lambda-1A · Intervention Types: Drug
Hospitalized Cohort - placebo
Other
PlaceboComparator Group · 1 Intervention: placebo · Intervention Types: Other
Ambulatory Cohort - placebo
Other
PlaceboComparator Group · 1 Intervention: placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peginterferon lambda-1a
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 0-7, 10, 12, 14, 18, 21, 25 and 28

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,382 Previous Clinical Trials
473,235 Total Patients Enrolled
Michael Garron HospitalOTHER
12 Previous Clinical Trials
4,345 Total Patients Enrolled
Jordan Feld, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
763 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an adult patient between the ages of 18 and 75 years.
You have been discharged to home isolation.
You are willing and able to follow-up by daily phone or videoconference.
References

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