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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354259
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE April 16, 2020
First Posted Date  ICMJE April 21, 2020
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE May 13, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2020)
  • 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.
  • Cohort A (Ambulatory) - Treatment-emergent and treatment related serious adverse events (Primary Safety Endpoint) [ Time Frame: Day 0 to Day 30 ]
    The rate of treatment-emergent and treatment-related serious adverse events (SAEs)
  • Cohort B (Hospitalized) - Time to viral negativity (Primary Efficacy Endpoint) [ Time Frame: Day 0 to day 28 ]
    Time to SARS-CoV-2 RNA negativity.
  • Cohort B (Hospitalized) - treatment-emergent and treatment-related serious adverse events (Primary Safety Endpoint) [ Time Frame: Day 0 to Day 30 ]
    The rate of treatment-emergent and treatment-related serious adverse events (SAEs)
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • Cohort A (Ambulatory) - Primary Efficacy Endpoint [ Time Frame: At day 8 ]
    The proportion of participants with negative SARS-CoV-2 RNA on nasopharyngeal swab.
  • Cohort A (Ambulatory) - Primary Safety Endpoint [ Time Frame: Day 1 to Day 15 ]
    Rate of combined treatment-emergent and treatment-related severe adverse events (SAEs).
  • Cohort B (Hospitalized) - Primary Efficacy Endpoint [ Time Frame: At Day 15 ]
    The proportion of participants with negative SARS-CoV-2 RNA on nasopharyngeal swab.
  • Cohort B (Hospitalized) - Primary Safety Endpoint [ Time Frame: Day 1 to Day 30 ]
    Rate of combined treatment-emergent and treatment-related severe adverse events (SAEs).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2020)
  • Cohort A (Ambulatory) - Symptom Resolution (Clinical Outcome #1) [ Time Frame: Day 0 to Day 14 ]
    Time to resolution of symptoms (fever, cough, diarrhea)
  • 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
  • Cohort A (Ambulatory) - Hospitalization (Clinical Outcome #3) [ Time Frame: Day 0 to Day 14 ]
    Proportion with need for hospital admission
  • Cohort A (Ambulatory) - Adverse and serious adverse events (Clinical Outcome #4) [ Time Frame: Day 0 to Day 14 ]
    Adverse events and serious adverse events
  • 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
  • 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
  • Cohort A (Ambulatory) - Proportion viremic (Virologic/Immunological Outcome #3) [ Time Frame: Day 0 and Day 7 ]
    Proportion with SARS-CoV-2 RNA in blood.
  • Cohort A (Ambulatory) - Proportion with antibodies (Virologic/Immunological Outcome #4) [ Time Frame: Day 0 and Day 7 ]
    Proportion with SARS-CoV-2 antibodies blood
  • 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
  • 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)
  • 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
  • Cohort B (Hospitalized) - ICU admission (Clinical Outcome #1) [ Time Frame: Day 0 to day 30 ]
    Proportion with ICU admission during hospitalization
  • Cohort B (Hospitalized) - Need for intubation (Clinical Outcome #2) [ Time Frame: Day 0 to Day 14 ]
    Proportion with need for intubation
  • Cohort B (Hospitalized) - Length of hospital stay (Clinical Outcome #3) [ Time Frame: Day 0 to Day 14 ]
    Length of hospital stay (days)
  • Cohort B (Hospitalized) - Change in respiratory symptom score (Clinical Outcome #4) [ Time Frame: Day 0 to 7 and Day 0 to 14 ]
    Change in respiratory symptom score (score 0 to 7 with higher scores indicating more severe disease)
  • Cohort B (Hospitalized) - Readmission to hospital (Clinical Outcome #5) [ Time Frame: By day 30 and Day 90 ]
    Proportion with readmission to hospital
  • Cohort B (Hospitalized) - All-cause mortality (Clinical Outcome #6) [ Time Frame: At day 30 and day 90 ]
    All-cause mortality
  • Cohort B (Hospitalized) - COVID-19-related mortality (Clinical Outcome #7) [ Time Frame: At day 30 ]
    COVID-19-related mortality
  • Cohort B (Hospitalized) - Adverse (AEs) and Serious Adverse Events (SAEs) (Clinical Outcome #8) [ Time Frame: Day 0 to day 30 ]
    Adverse (AEs) and Serious Adverse Events (SAEs)
  • Cohort B (Hospitalized) - Dose reduction or dose omission (Clinical Outcome #9) [ Time Frame: Day 7 to day 11 ]
    Frequency of dose reduction or dose omission for the second dose of peginterferon lambda
  • Cohort B (Hospitalized) - Proportion negative swab. (Virologic/Immunological Outcome #1) [ Time Frame: Day 7 ]
    Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab.
  • Cohort B (Hospitalized) - Proportion negative by day 14 (Virologic/Immunological Outcome) #2) [ Time Frame: Day 14 ]
    Proportion negative for SARS-CoV-2 by nasopharyngeal swab
  • Cohort B (Hospitalized) - Time to negativity by rectal swab (Virologic/Immunological Outcome #3) [ Time Frame: Day 0 to day 14 ]
    Time to SARS-CoV-2 RNA negativity by rectal swab
  • 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
  • Cohort B (Hospitalized) - Proportion with Antibody (Virologic/Immunological Outcome #6) [ Time Frame: At Day 7 and Day 14 ]
    Proportion with SARS-CoV-2 Antibody.
  • Cohort B (Hospitalized) - Proportion with viremia (Virologic/Immunological Outcome #7) [ Time Frame: Day 0, Day 7, and Day 14 ]
    Proportion with SARS-CoV-2 RNA in blood
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • Cohort A (Ambulatory) - Clinical Outcome #1 [ Time Frame: Day 1 to Day 15 ]
    Time to resolution of all symptoms (fever, cough, diarrhea)
  • Cohort A (Ambulatory) - Clinical Outcome #2 [ Time Frame: Day 1 to Day 8 ]
    Change in respiratory symptom score.
  • Cohort A (Ambulatory) - Clinical Outcome #3 [ Time Frame: Day 1 to Day 8 ]
    Change in gastrointestinal symptom score.
  • Cohort A (Ambulatory) - Clinical Outcome #4 [ Time Frame: Day 1 to Day 8 ]
    Change in fever symptom score.
  • Cohort A (Ambulatory) - Clinical Outcome #5 [ Time Frame: Day 1 to Day 15 ]
    Need for hospital admission.
  • Cohort A (Ambulatory) - Clinical Outcome #6 [ Time Frame: Day 1 to Day 15 ]
    Adverse events.
  • Cohort A (Ambulatory) - Clinical Outcome #7 [ Time Frame: Day 1 to Day 15 ]
    Serious adverse events.
  • Cohort A (Ambulatory) - Virologic/Immunological Outcome #1 [ Time Frame: At Day 4 ]
    Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab
  • Cohort A (Ambulatory) - Virologic/Immunological Outcome #2 [ Time Frame: Day 1 to Day 15 ]
    Time to SARS-CoV-2 RNA negativity on mid-turbinate nasal swab
  • Cohort A (Ambulatory) - Virologic/Immunological Outcome #3 [ Time Frame: Day 1 and Day 8 ]
    Proportion with SARS-CoV-2 RNA in blood and saliva.
  • Cohort A (Ambulatory) - Virologic/Immunological Outcome #4 [ Time Frame: Day 1 and Day 8 ]
    Proportion with SARS-CoV-2 antibodies blood and saliva.
  • Cohort A (Ambulatory) - Virologic/Immunological Outcome #5 [ Time Frame: Through day 8 ]
    Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab by interferon lambda 4 (IFNL4) genotype
  • Cohort A (Ambulatory) - Virologic/Immunological Outcome #6 [ Time Frame: Day 1 to Day 8 ]
    Change in laboratory and inflammatory markers (hemoglobin, white blood cell count, lymphocyte count, ferritin, lactate dehydrogenase, c-reactive protein, D-dimers, troponin).
  • Cohort A (Ambulatory) - Transmission Outcome #1 [ Time Frame: Day 1 to Day 15 ]
    Proportion with symptom development among household contacts
  • Cohort A (Ambulatory) - Transmission Outcome #2 [ Time Frame: Day 1 to Day 30 ]
    Proportion with confirmed diagnosis of COVID-19 among household contacts.
  • Cohort B (Hospitalized) - Clinical Outcome #1 [ Time Frame: Day 1 to day 30 ]
    ICU admission during hospitalization
  • Cohort B (Hospitalized) - Clinical Outcome #2 [ Time Frame: Day 1 to Day 15 ]
    Need for intubation
  • Cohort B (Hospitalized) - Clinical Outcome #3 [ Time Frame: Day 1 to Day 15 ]
    Length of hospital stay
  • Cohort B (Hospitalized) - Clinical Outcome #4 [ Time Frame: Day 0 to 8 and Day 0 to 15 ]
    Change in respiratory symptom score
  • Cohort B (Hospitalized) - Clinical Outcome #5 [ Time Frame: By day 30 and Day 90 ]
    Readmission to hospital
  • Cohort B (Hospitalized) - Clinical Outcome #6 [ Time Frame: At day 30 and day 90 ]
    All-cause mortality
  • Cohort B (Hospitalized) - Clinical Outcome #7 [ Time Frame: At day 30 ]
    COVID-19-related mortality
  • Cohort B (Hospitalized) - Clinical Outcome #8 [ Time Frame: At Day 15 ]
    Resolution of CXR findings
  • Cohort B (Hospitalized) - Clinical Outcome #9 [ Time Frame: By day 30 ]
    Adverse (AEs)
  • Cohort B (Hospitalized) - Clinical Outcome #10 [ Time Frame: By day 30 ]
    Serious Adverse Events (SAEs)
  • Cohort B (Hospitalized) - Clinical Outcome #11 [ Time Frame: Day 8 to day 12 ]
    Frequency of dose reduction or dose omission for the second dose of peginterferon lambda
  • Cohort B (Hospitalized) - Virologic/Immunological Outcome #1 [ Time Frame: Day 8 ]
    Proportion negative for SARS-CoV-2 RNA by NP swab.
  • Cohort B (Hospitalized) - Virologic/Immunological Outcome #2 [ Time Frame: Day 1 to Day 15 ]
    Time to SARS-CoV-2 RNA negativity by nasopharyngeal swab
  • Cohort B (Hospitalized) - Virologic/Immunological Outcome #3 [ Time Frame: Through Day 15 ]
    Correlation of clinical and virologic response with interferon lambda 4 (IFNL4) genotype
  • Cohort B (Hospitalized) - Virologic/Immunological Outcome #4 [ Time Frame: From day 0 to day 8 and to day 15 ]
    Change in laboratory and inflammatory markers (hemoglobin, white blood cell count, lymphocyte count, ferritin, lactate dehydrogenase, c-reactive protein, D-dimers, troponin)
  • Cohort B (Hospitalized) - Virologic/Immunological Outcome #5 [ Time Frame: Day 0 to Day 8 ]
    Time to SARS-CoV-2 RNA negativity by rectal swab
  • Cohort B (Hospitalized) - Virologic/Immunological Outcome #6 [ Time Frame: At Day 8 and Day 15 ]
    Proportion with SARS-CoV-2 Antibody.
  • Cohort B (Hospitalized) - Virologic/Immunological Outcome #7 [ Time Frame: Day 0, Day 8, and Day 15 ]
    Proportion with SARS-CoV-2 RNA in blood and saliva.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19
Official Title  ICMJE 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
Brief 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. 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.
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 7. The primary endpoint will be the time to negative SARS-CoV-2 RNA by nasopharyngeal swab . In addition to the primary endpoints 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sars-CoV2
  • Covid-19
Intervention  ICMJE
  • Drug: Peginterferon Lambda-1A
    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.
  • Other: placebo
    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 Arms  ICMJE
  • Experimental: Ambulatory Cohort - Treatment
    to receive a single dose of peginterferon lambda 180µg SC at baseline (day 0).
    Intervention: Drug: Peginterferon Lambda-1A
  • 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.
    Intervention: Other: placebo
  • Experimental: Hospitalized Cohort - Treatment
    To receive a dose of peginterferon lambda 180µg SC at baseline and a second dose on day 7.
    Intervention: Drug: Peginterferon Lambda-1A
  • 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 7.
    Intervention: Other: placebo
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2020)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Cohort A - Ambulatory

Inclusion Criteria

  1. Adult patients between the ages of 18 and 70 years.
  2. Confirmed COVID-19 infection by PCR within 5 days of symptom onset (fever, respiratory symptoms, sore throat).
  3. Discharged to home isolation.
  4. Willing and able to sign informed consent.
  5. Willing and able to follow-up by daily phone or videoconference.
  6. 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.

Exclusion Criteria

  1. Requirement for hospital admission
  2. Current immunosuppression due to medication (steroids, biologics, chemotherapy) or underlying condition such as known HIV or organ/bone marrow transplant
  3. Pregnancy (or positive urine pregnancy test) or lactating
  4. The following pre-existing medical conditions:

    1. Known seizure disorder
    2. Known retinal disease requiring therapy
    3. Known autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (rheumatoid arthritis, lupus, inflammatory bowel disease)
    4. Known history of chronic obstructive pulmonary disease (COPD) or asthma associated with functional impairment or with any history of hospitalization for an exacerbation
    5. Known cirrhosis with any history of decompensation (ascites, variceal bleeding or hepatic encephalopathy)
    6. Known chronic kidney disease with estimated creatine clearance < 50 mL/minute or need for dialysis
    7. Severe psychiatric disorder - schizophrenia, bipolar disorder, depression with prior suicidality
    8. 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
  5. Advanced cancer or other illness with life expectancy of < 1 year
  6. Known prior intolerance to interferon treatment
  7. Enrolment in another clinical trial with use of any investigational agent in the prior 30 days
  8. Use of off-label therapy for COVID-19

Cohort B - Hospitalized

Inclusion Criteria

  1. Adult patients over age 18
  2. SARS-CoV-2 RNA-positive on nasopharyngeal swab/respiratory specimen within 5 days of symptom onset
  3. Admitted to hospital for management of COVID-19
  4. Willing and able to provide informed consent
  5. 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.

    Exclusion Criteria

  6. Severity of illness

    1. Respiratory failure (requiring>5L O2 or intubation in the ER)
    2. Shock - systolic BP<90 mmHg or mean arterial BP<60 mmHg after fluid resuscitation
  7. Current immunosuppression due to medication (steroids, biologics, chemotherapy) or underlying condition such as known HIV or organ/bone marrow transplant
  8. Pregnancy (or positive urine pregnancy test) or lactating
  9. The following pre-existing medical conditions:

    1. Known seizure disorder
    2. Known retinal disease requiring therapy
    3. Known autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (rheumatoid arthritis, lupus, inflammatory bowel disease)
    4. Known history of chronic obstructive pulmonary disease (COPD) or asthma associated with functional impairment or with any history of hospitalization for an exacerbation
    5. Known cirrhosis with any history of decompensation (ascites, variceal bleeding or hepatic encephalopathy)
    6. Known chronic kidney disease with estimated creatine clearance < 50 mL/minute or need for dialysis
    7. Severe psychiatric disorder - schizophrenia, bipolar disorder, depression with prior suicidality
    8. 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
  10. Known alcohol or drug dependence that in the opinion of the investigator would impair study participation
  11. Known prior intolerance to interferon treatment
  12. Enrolment in another clinical trial with use of any investigational agent in the prior 30 days
  13. Use of off-label therapy for COVID-19
  14. Any of the following abnormal laboratory indices

    1. Hemoglobin < 100 mg/dL
    2. Platelet count < 75,000 cells/mm3
    3. Absolute neutrophil count < 1,000 cells/mm3
    4. Estimated creatinine clearance < 50 cc/mL
    5. Total bilirubin > 2x upper limit of normal (ULN)
    6. Alanine aminotransferase (ALT) > 10x ULN
    7. Aspartate aminotransferase (AST) > 10x ULN
    8. Lipase > 2x ULN
    9. Random blood glucose > 20 mmol/L
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Josh Booth (416) 340-4800 ext 6486 joshua.booth@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04354259
Other Study ID Numbers  ICMJE JF-4-2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jordan Feld, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP