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Sars-CoV2Phase 2ILIADNCT04354259

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

A Phase 2 study testing Peginterferon Lambda-1A in people with Sars-CoV2 and Covid-19, run by University Health Network, Toronto at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sars-CoV2, Covid-19
What is being tested?
Peginterferon Lambda-1A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
157 participants
Where
7 sitesin 2 countries
Study dates
13 May 2020to 8 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients between the ages of 18 and 75 years.
  • Confirmed COVID-19 infection by PCR within 7 days of symptom onset (fever, respiratory symptoms, sore throat).
  • Discharged to home isolation.
  • Willing and able to sign informed consent.
  • Willing and able to follow-up by daily phone or videoconference.
  • Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. Female patients of childbearing potential are all those except patients who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal. Adequate methods of contraception are:
Show all 15Show fewer
  • For female patients i. Hormonal contraceptives including progestogen injection (eg, Depo-Provera®), combined oral contraceptive pill or vaginal ring for ≥ 3 months before screening AND a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or ii. Intrauterine device (IUD) or intrauterine system (IUS) in place ≥ 3 months before screening AND a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or iii. Surgical sterilization of the partner (vasectomy ≥ 1 month before screening) AND a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or iv. Double-barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from screening.
  • For male patients i. Surgical sterilization (vasectomy ≥ 1 month before screening) AND a barrier method (use of condom or diaphragm with spermicide or cervical cap with spermicide) from screening, or ii. Consistently and correctly use a condom from screening AND female partner must agree to use a hormonal contraceptive, a nonhormonal nonbarrier method (eg, copper IUD), or a nonhormonal barrier method (eg, diaphragm with spermicide or cervical cap with spermicide).
  • Adult patients over age 18
  • SARS-CoV-2 RNA-positive on nasopharyngeal swab/respiratory specimen within 10 days of symptom onset
  • Admitted to hospital for management of COVID-19
  • Willing and able to provide informed consent
  • Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. Female patients of childbearing potential are all those except patients who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal. Adequate methods of contraception are:
  • For female patients: i. Hormonal contraceptives including progestogen injection (eg, Depo-Provera®), combined oral contraceptive pill or vaginal ring for ≥ 3 months before screening AND a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or ii. Intrauterine device (IUD) or intrauterine system (IUS) in place ≥ 3 months before screening AND a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or iii. Surgical sterilization of the partner (vasectomy ≥ 1 month before screening) AND a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or iv. Double-barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from screening.
  • For male patients: i. Surgical sterilization (vasectomy ≥ 1 month before screening) AND a barrier method (use of condom or diaphragm with spermicide or cervical cap with spermicide) from screening, or ii. Consistently and correctly use a condom from screening AND female partner must agree to use a hormonal contraceptive, a nonhormonal nonbarrier method (eg, copper IUD), or a nonhormonal barrier method (eg, diaphragm with spermicide or cervical cap with spermicide).

Who cannot join

  • Requirement for hospital admission
  • Current immunosuppression due to medication (steroids, biologics, chemotherapy) or underlying condition such as organ/bone marrow transplant or untreated HIV or HIV infection with detectable HIV RNA and/or CD4 count of <500.
  • Pregnancy (or positive urine pregnancy test) or lactating
  • The following pre-existing medical conditions:
  • Known seizure disorder
  • Known retinal disease requiring therapy
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  • Known autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (rheumatoid arthritis, lupus, inflammatory bowel disease)
  • Known history of chronic obstructive pulmonary disease (COPD) or asthma associated with functional impairment
  • Known cirrhosis with any history of decompensation (ascites, variceal bleeding or hepatic encephalopathy)
  • Known chronic kidney disease with estimated creatinine clearance < 50 mL/minute or need for dialysis
  • Severe psychiatric disorder - schizophrenia, bipolar disorder, depression with prior suicidality
  • Any other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of peginterferon lambda
  • Advanced cancer or other illness with life expectancy of < 1 year
  • Known alcohol or drug dependence that in the opinion of the investigator would impair study participation
  • Known prior intolerance to interferon treatment
  • Enrolment in another clinical trial with use of any investigational agent in the prior 30 days
  • Use of off-label therapy for COVID-19
  • Cohort B - Hospitalized
  • Severity of illness
  • Respiratory failure (requiring>6L O2 or intubation in the ER)
  • Shock - systolic BP<90 mmHg or mean arterial BP<60 mmHg after fluid resuscitation
  • Pregnancy (or positive urine pregnancy test) or lactating
  • The following pre-existing medical conditions:
  • Known seizure disorder
  • Known retinal disease requiring therapy
  • Known autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (rheumatoid arthritis, lupus, inflammatory bowel disease)
  • Known cirrhosis with any history of decompensation (ascites, variceal bleeding or hepatic encephalopathy)
  • Known chronic kidney disease with estimated creatinine clearance < 30 mL/minute or need for dialysis
  • Severe psychiatric disorder - uncontrolled schizophrenia, bipolar disorder, depression with prior suicidality
  • Any other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of peginterferon lambda
  • Known prior intolerance to interferon treatment
  • Enrolment in another clinical trial with use of an antiviral agent in the prior 30 days (co-enrollment with immunomodulatory agents permitted)
  • Use of off-label therapy for COVID-19
  • Any of the following abnormal laboratory indices
  • Hemoglobin < 100 mg/dL
  • Platelet count < 75,000 cells/mm3
  • Absolute neutrophil count < 1,000 cells/mm3
  • Estimated creatinine clearance < 30 cc/mL
  • Total bilirubin > 2x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) > 5x ULN
  • Aspartate aminotransferase (AST) > 5x ULN
  • Lipase or amylase > 2x ULN
  • Random blood glucose > 20 mmol/L

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Canada4 sites

  • University of Calgary

    Calgary, Alberta, T2N 2T9

  • Michael Garron Hospital

    Toronto, Ontario, M4C 3E7

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Brazil3 sites

  • Hospital das Clínicas da Faculdade de Medicina de Botucatu

    Botucatu

  • Hospital Alemão Oswaldo Cruz

    São Paulo

  • Hospital das Clínicas São Paulo

    São Paulo

Other trials in Brazil

About this study

Official title: Interferon Lambda for Immediate Antiviral Therapy at Diagnosis (ILIAD): A Phase II Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19

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.

Read the detailed 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.

Conditions
Sars-CoV2, Covid-19
Being tested
Peginterferon Lambda-1A, placebo
Keywords
peginterferon lambda
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peginterferon Lambda-1ADrug

    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.

  • placeboOther

    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.

Study groups in NCT04354259
Study groupRoleWhat they receive
Ambulatory Cohort - TreatmentExperimentalto receive a single dose of peginterferon lambda 180µg SC at baseline (day 0).
Receives: Drug: Peginterferon Lambda-1A
Ambulatory Cohort - placeboPlacebo comparatorPatients 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.
Receives: Other: placebo
Hospitalized Cohort - TreatmentExperimentalTo receive a dose of peginterferon lambda 180µg SC at baseline and a second dose on day 5.
Receives: Drug: Peginterferon Lambda-1A
Hospitalized Cohort - placeboPlacebo comparatorPatients 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.
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The proportion of participants with negative SARS-CoV-2 RNA on nasopharyngeal swab.

    Measured: At day 7

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

    The rate of treatment-emergent and treatment-related serious adverse events (SAEs)

    Measured: Day 0 to Day 28

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

    Clinical status on an ordinal scale at Day 14

    Measured: At Day 14

  4. Cohort B (Hospitalized) - treatment-emergent and treatment-related serious adverse events (Primary Safety Endpoint)

    The rate of treatment-emergent and treatment-related serious adverse events (SAEs)

    Measured: Day 0 to Day 28

Secondary outcomes (42)

  1. Cohort A (Ambulatory) - Symptom Resolution (Clinical Outcome #1)

    Time to resolution of symptoms (fever, cough, diarrhea)

    Measured: Day 0 to Day 14

  2. Cohort A (Ambulatory) - Symptom severity scores (Clinical Outcome #2)

    Change in relative categorical symptom scores (respiratory, gastrointestinal, fever) - none, mild, moderate, severe and no change, worse, better

    Measured: Day 0 to Day 7

  3. Cohort A (Ambulatory) - Hospitalization (Clinical Outcome #3)

    Proportion with need for hospital admission

    Measured: Day 0 to Day 14

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

    Adverse events and serious adverse events

    Measured: Day 0 to Day 14

  5. Cohort A (Ambulatory) - Swab negative at day 3 (Virologic/Immunological Outcome #1)

    Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab

    Measured: At Day 3

  6. Cohort A (Ambulatory) - Time RNA negativity (Virologic/Immunological Outcome #2)

    Time to SARS-CoV-2 RNA negativity on mid-turbinate nasal swab or saliva

    Measured: Day 0 to Day 14

  7. Cohort A (Ambulatory) - Proportion viremic (Virologic/Immunological Outcome #3)

    Proportion with SARS-CoV-2 RNA in blood.

    Measured: Day 0 and Day 7

  8. Cohort A (Ambulatory) - Proportion with antibodies (Virologic/Immunological Outcome #4)

    Proportion with SARS-CoV-2 antibodies blood

    Measured: Day 0 and Day 7

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

    Correlation of virologic response with interferon lambda 4 (IFNL4) genotype

    Measured: Through day 7

  10. Cohort A (Ambulatory) - Symptoms in household contacts (Transmission Outcome #1)

    Proportion with symptom development in household contacts (categorical symptom type yes/no)

    Measured: Day 0 to Day 14

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

    Proportion with confirmed diagnosis of COVID-19 in household contacts

    Measured: At Day 30

  12. Cohort B (Hospitalized) - Ordinal scale (Clinical Outcome #1)

    Clinical status on the ordinal scale

    Measured: At Days 7, 21 and 28

  13. Cohort B (Hospitalized) - ICU admission (Clinical Outcome #2)

    Proportion with ICU admission during hospitalization

    Measured: Day 0 to day 28

  14. Cohort B (Hospitalized) - Need for intubation (Clinical Outcome #3)

    Proportion with need for intubation

    Measured: Day 0 to Day 14 and to Day 28

  15. Cohort B (Hospitalized) - Length of hospital stay (Clinical Outcome #4)

    Length of hospital stay (days)

    Measured: Day 0 to Day 14

  16. Cohort B (Hospitalized) - Change in respiratory symptom score (Clinical Outcome #5)

    Change in respiratory symptom score (score 0 to 7 with higher scores indicating more severe disease)

    Measured: Day 0 to 7, Day 0 to 14, and Day 0 to 28

  17. Cohort B (Hospitalized) - All-cause mortality (Clinical Outcome #6)

    All-cause mortality

    Measured: At day 28 and day 90

  18. Cohort B (Hospitalized) - Readmission to hospital (Clinical Outcome #7)

    Proportion with readmission to hospital

    Measured: From Day 0 -28 and from Day 0 - 90

  19. Cohort B (Hospitalized) - COVID-19-related mortality (Clinical Outcome #8)

    COVID-19-related mortality

    Measured: At day 28

  20. Cohort B (Hospitalized) - Adverse (AEs) and Serious Adverse Events (SAEs) (Clinical Outcome #9)

    Adverse (AEs) and Serious Adverse Events (SAEs)

    Measured: Day 0 to day 28

  21. Cohort B (Hospitalized) - Dose reduction or dose omission (Clinical Outcome #10)

    Frequency of dose reduction or dose omission for the second dose of peginterferon lambda

    Measured: Day 5 to day 9

  22. Cohort B (Hospitalized) - Time to viral negativity (Virologic/Immunological Outcome #1)

    Time to SARS-CoV-2 RNA negativity.

    Measured: Day 0 - Day 28

  23. Cohort B (Hospitalized) - Proportion negative swab. (Virologic/Immunological Outcome #2)

    Proportion negative for SARS-CoV-2 RNA by mid-turbinate swab

    Measured: Days 0-7, 10, 12, 14, 18, 21, 25 and 28

  24. Cohort B (Hospitalized) - Quantitative viral load by nasal swab (Virologic/Immunological Outcome #3)

    Change in quantitative SARS-CoV-2 RNA by mid-turbinate swab over time

    Measured: Day 0 - Day 28

  25. Cohort B (Hospitalized) - Correlation with interferon lambda 4 (IFNL4) genotype (Virologic/Immunological Outcome #4)

    Correlation of virologic response with interferon lambda 4 (IFNL4) genotype

    Measured: Through Day 14

  26. Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #5)

    Change in hemoglobin over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  27. Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #6)

    Change in white blood cell count over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  28. Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #7)

    Change in lymphocyte count over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  29. Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #8)

    Change in platelet count over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  30. Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #9)

    Change in ALT over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  31. Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #10)

    Change in AST over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  32. Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #11)

    Change in ALP over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  33. Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #12)

    Change in bilirubin over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  34. Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #13)

    Change in albumin over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  35. Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #14)

    Change in ferritin over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  36. Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #15)

    Change in lactate dehydrogenase over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  37. Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #16)

    Change in c-reactive protein over time

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  38. Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #17)

    Change in D-dimers over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  39. Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #18)

    Change in creatine kinase over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  40. Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #19)

    Change in troponin over time.

    Measured: From Day 0 - Day 7 and to Day 14, 21, and 28

  41. Cohort B (Hospitalized) - Proportion with Antibody (Virologic/Immunological) Outcome #20)

    Proportion with SARS-CoV-2 Antibody.

    Measured: At Day 7, 14, 21, and 28

  42. Cohort B (Hospitalized) - Proportion with viremia (Virologic/Immunological Outcome #21)

    Proportion with SARS-CoV-2 RNA in blood

    Measured: Day 0, Day 7, 14, 21, and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start13 May 2020
  3. Primary completion19 Aug 2022
  4. Study completion8 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04354259
Sponsor's protocol ID
20-5334
Acronym
ILIAD
Status last verified
Dec 2023
First submitted
16 Apr 2020
Last updated
13 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Feld JJ, Kandel C, Biondi MJ, Kozak RA, Zahoor MA, Lemieux C, Borgia SM, Boggild AK, Powis J, McCready J, Tan DHS, Chan T, Coburn B, Kumar D, Humar A, Chan A, O'Neil B, Noureldin S, Booth J, Hong R, Smookler D, Aleyadeh W, Patel A, Barber B, Casey J, Hiebert R, Mistry H, Choong I, Hislop C, Santer DM, Lorne Tyrrell D, Glenn JS, Gehring AJ, Janssen HLA, Hansen BE. Peginterferon lambda for the treatment of outpatients with COVID-19: a phase 2, placebo-controlled randomised trial. Lancet Respir Med. 2021 May;9(5):498-510. doi: 10.1016/S2213-2600(20)30566-X. Epub 2021 Feb 5.

    PubMed 33556319

  • Lee JS, Shin EC. The type I interferon response in COVID-19: implications for treatment. Nat Rev Immunol. 2020 Oct;20(10):585-586. doi: 10.1038/s41577-020-00429-3.

    PubMed 32788708

  • Moschen AR. IBD in the time of corona - vigilance for immune-mediated diseases. Nat Rev Gastroenterol Hepatol. 2020 Sep;17(9):529-530. doi: 10.1038/s41575-020-0333-5.

    PubMed 32555385

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peginterferon Lambda-1A in people with Sars-CoV2 and Covid-19, run by University Health Network, Toronto at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort A (Ambulatory) - Proportion swab negative at day 7 (Primary efficacy endpoint) (time frame: At day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04354259, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.

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