- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354259
Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19 (ILIAD)
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Shinthuka Jeganathan, MBBS
- Phone Number: 6465 (416) 340-4800
- Email: shinthuka.jeganathan@uhn.ca
Study Contact Backup
- Name: Bethany Barber
- Phone Number: 6569 (416) 340-4800
- Email: Bethany.Barber@uhn.ca
Study Locations
-
-
-
Botucatu, Brazil
- Hospital das Clínicas da Faculdade de Medicina de Botucatu
-
Sao Paulo, Brazil
- Hospital das Clínicas São Paulo
-
São Paulo, Brazil
- Hospital Alemão Oswaldo Cruz
-
-
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 2T9
- University of Calgary
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
Toronto, Ontario, Canada, M4C 3E7
- Michael Garron Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Cohort A - Ambulatory
Inclusion Criteria
- 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:
a. 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.
b. 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).
Exclusion Criteria
- 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
- 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
Inclusion Criteria
- 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:
a. 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.
b. 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).
Exclusion Criteria
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ambulatory Cohort - Treatment
to receive a single dose of peginterferon lambda 180µg SC at baseline (day 0).
|
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.
|
Placebo Comparator: Ambulatory Cohort - placebo
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.
|
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.
|
Experimental: Hospitalized Cohort - Treatment
To receive a dose of peginterferon lambda 180µg SC at baseline and a second dose on day 5.
|
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.
|
Placebo Comparator: Hospitalized Cohort - placebo
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cohort A (Ambulatory) - Proportion swab negative at day 7 (Primary efficacy endpoint)
Time Frame: At day 7
|
The proportion of participants with negative SARS-CoV-2 RNA on nasopharyngeal swab.
|
At day 7
|
Cohort A (Ambulatory) - Treatment-emergent and treatment related serious adverse events (Primary Safety Endpoint)
Time Frame: Day 0 to Day 28
|
The rate of treatment-emergent and treatment-related serious adverse events (SAEs)
|
Day 0 to Day 28
|
Cohort B (Hospitalized) - Ordinal Scale (Primary Efficacy Endpoint)
Time Frame: At Day 14
|
Clinical status on an ordinal scale at Day 14
|
At Day 14
|
Cohort B (Hospitalized) - treatment-emergent and treatment-related serious adverse events (Primary Safety Endpoint)
Time Frame: Day 0 to Day 28
|
The rate of treatment-emergent and treatment-related serious adverse events (SAEs)
|
Day 0 to Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cohort A (Ambulatory) - Symptom Resolution (Clinical Outcome #1)
Time Frame: Day 0 to Day 14
|
Time to resolution of symptoms (fever, cough, diarrhea)
|
Day 0 to Day 14
|
Cohort A (Ambulatory) - Symptom severity scores (Clinical Outcome #2)
Time Frame: Day 0 to Day 7
|
Change in relative categorical symptom scores (respiratory, gastrointestinal, fever) - none, mild, moderate, severe and no change, worse, better
|
Day 0 to Day 7
|
Cohort A (Ambulatory) - Hospitalization (Clinical Outcome #3)
Time Frame: Day 0 to Day 14
|
Proportion with need for hospital admission
|
Day 0 to Day 14
|
Cohort A (Ambulatory) - Adverse and serious adverse events (Clinical Outcome #4)
Time Frame: Day 0 to Day 14
|
Adverse events and serious adverse events
|
Day 0 to Day 14
|
Cohort A (Ambulatory) - Swab negative at day 3 (Virologic/Immunological Outcome #1)
Time Frame: At Day 3
|
Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab
|
At Day 3
|
Cohort A (Ambulatory) - Time RNA negativity (Virologic/Immunological Outcome #2)
Time Frame: Day 0 to Day 14
|
Time to SARS-CoV-2 RNA negativity on mid-turbinate nasal swab or saliva
|
Day 0 to Day 14
|
Cohort A (Ambulatory) - Proportion viremic (Virologic/Immunological Outcome #3)
Time Frame: Day 0 and Day 7
|
Proportion with SARS-CoV-2 RNA in blood.
|
Day 0 and Day 7
|
Cohort A (Ambulatory) - Proportion with antibodies (Virologic/Immunological Outcome #4)
Time Frame: Day 0 and Day 7
|
Proportion with SARS-CoV-2 antibodies blood
|
Day 0 and Day 7
|
Cohort A (Ambulatory) - Correlation with interferon lambda 4 genotype (Virologic/Immunological Outcome #5)
Time Frame: Through day 7
|
Correlation of virologic response with interferon lambda 4 (IFNL4) genotype
|
Through day 7
|
Cohort A (Ambulatory) - Symptoms in household contacts (Transmission Outcome #1)
Time Frame: Day 0 to Day 14
|
Proportion with symptom development in household contacts (categorical symptom type yes/no)
|
Day 0 to Day 14
|
Cohort A (Ambulatory) - COVID-19 in household contacts (Transmission Outcome #2)
Time Frame: At Day 30
|
Proportion with confirmed diagnosis of COVID-19 in household contacts
|
At Day 30
|
Cohort B (Hospitalized) - Ordinal scale (Clinical Outcome #1)
Time Frame: At Days 7, 21 and 28
|
Clinical status on the ordinal scale
|
At Days 7, 21 and 28
|
Cohort B (Hospitalized) - ICU admission (Clinical Outcome #2)
Time Frame: Day 0 to day 28
|
Proportion with ICU admission during hospitalization
|
Day 0 to day 28
|
Cohort B (Hospitalized) - Need for intubation (Clinical Outcome #3)
Time Frame: Day 0 to Day 14 and to Day 28
|
Proportion with need for intubation
|
Day 0 to Day 14 and to Day 28
|
Cohort B (Hospitalized) - Length of hospital stay (Clinical Outcome #4)
Time Frame: Day 0 to Day 14
|
Length of hospital stay (days)
|
Day 0 to Day 14
|
Cohort B (Hospitalized) - Change in respiratory symptom score (Clinical Outcome #5)
Time Frame: Day 0 to 7, Day 0 to 14, and Day 0 to 28
|
Change in respiratory symptom score (score 0 to 7 with higher scores indicating more severe disease)
|
Day 0 to 7, Day 0 to 14, and Day 0 to 28
|
Cohort B (Hospitalized) - All-cause mortality (Clinical Outcome #6)
Time Frame: At day 28 and day 90
|
All-cause mortality
|
At day 28 and day 90
|
Cohort B (Hospitalized) - Readmission to hospital (Clinical Outcome #7)
Time Frame: From Day 0 -28 and from Day 0 - 90
|
Proportion with readmission to hospital
|
From Day 0 -28 and from Day 0 - 90
|
Cohort B (Hospitalized) - COVID-19-related mortality (Clinical Outcome #8)
Time Frame: At day 28
|
COVID-19-related mortality
|
At day 28
|
Cohort B (Hospitalized) - Adverse (AEs) and Serious Adverse Events (SAEs) (Clinical Outcome #9)
Time Frame: Day 0 to day 28
|
Adverse (AEs) and Serious Adverse Events (SAEs)
|
Day 0 to day 28
|
Cohort B (Hospitalized) - Dose reduction or dose omission (Clinical Outcome #10)
Time Frame: Day 5 to day 9
|
Frequency of dose reduction or dose omission for the second dose of peginterferon lambda
|
Day 5 to day 9
|
Cohort B (Hospitalized) - Time to viral negativity (Virologic/Immunological Outcome #1)
Time Frame: Day 0 - Day 28
|
Time to SARS-CoV-2 RNA negativity.
|
Day 0 - Day 28
|
Cohort B (Hospitalized) - Proportion negative swab. (Virologic/Immunological Outcome #2)
Time Frame: Days 0-7, 10, 12, 14, 18, 21, 25 and 28
|
Proportion negative for SARS-CoV-2 RNA by mid-turbinate swab
|
Days 0-7, 10, 12, 14, 18, 21, 25 and 28
|
Cohort B (Hospitalized) - Quantitative viral load by nasal swab (Virologic/Immunological Outcome #3)
Time Frame: Day 0 - Day 28
|
Change in quantitative SARS-CoV-2 RNA by mid-turbinate swab over time
|
Day 0 - Day 28
|
Cohort B (Hospitalized) - Correlation with interferon lambda 4 (IFNL4) genotype (Virologic/Immunological Outcome #4)
Time Frame: Through Day 14
|
Correlation of virologic response with interferon lambda 4 (IFNL4) genotype
|
Through Day 14
|
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #5)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in hemoglobin over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #6)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in white blood cell count over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #7)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in lymphocyte count over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #8)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in platelet count over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #9)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in ALT over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #10)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in AST over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #11)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in ALP over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #12)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in bilirubin over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #13)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in albumin over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #14)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in ferritin over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #15)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in lactate dehydrogenase over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #16)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in c-reactive protein over time
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #17)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in D-dimers over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #18)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in creatine kinase over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #19)
Time Frame: From Day 0 - Day 7 and to Day 14, 21, and 28
|
Change in troponin over time.
|
From Day 0 - Day 7 and to Day 14, 21, and 28
|
Cohort B (Hospitalized) - Proportion with Antibody (Virologic/Immunological) Outcome #20)
Time Frame: At Day 7, 14, 21, and 28
|
Proportion with SARS-CoV-2 Antibody.
|
At Day 7, 14, 21, and 28
|
Cohort B (Hospitalized) - Proportion with viremia (Virologic/Immunological Outcome #21)
Time Frame: Day 0, Day 7, 14, 21, and 28
|
Proportion with SARS-CoV-2 RNA in blood
|
Day 0, Day 7, 14, 21, and 28
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jordan Feld, MD, University Health Network, Toronto
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-5334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin... and other collaboratorsRecruitingCOVID-19 | Post-COVID-19 Syndrome | Post-Acute COVID-19 | Acute COVID-19China
Clinical Trials on Peginterferon Lambda-1A
-
Stanford UniversityCompleted
-
Bristol-Myers SquibbCompletedHepatitis CArgentina, Australia, Belgium, France, Germany, Italy, United States, Canada, Spain, Mexico, Austria, Poland, Netherlands, Korea, Republic of, Puerto Rico, New Zealand, Finland, Greece, Romania
-
Eiger BioPharmaceuticalsCompletedHepatitis D, ChronicIsrael, New Zealand, Pakistan
-
Bristol-Myers SquibbCompletedChronic Hepatitis C Virus Infection | Chronic Hepatitis B Virus InfectionUnited States
-
Eiger BioPharmaceuticalsActive, not recruitingHepatitis Delta VirusUnited States, France, Belgium, Spain, Italy, Turkey, Bulgaria, Germany, Israel, Romania, Georgia, Moldova, Republic of
-
Icahn School of Medicine at Mount SinaiEiger BioPharmaceuticalsWithdrawnSARS-CoV-2
-
Johns Hopkins UniversityEiger BioPharmaceuticalsTerminatedSars-CoV-2 InfectionUnited States
-
University Health Network, TorontoActive, not recruitingCovid19 | Sars-CoV2Canada
-
Bristol-Myers SquibbCompletedHepatitis C VirusBelgium, Germany, Spain, United States, Canada, Brazil, Austria, France, Israel, Switzerland, Italy, Russian Federation, Czechia, Poland, United Kingdom
-
Bristol-Myers SquibbCompletedHepatitis C Virus (HCV)Mexico, Korea, Republic of, Czech Republic