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

December 12, 2023 updated by: University Health Network, Toronto

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

157

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Cohort A - Ambulatory

Inclusion Criteria

  1. Adult patients between the ages of 18 and 75 years.
  2. Confirmed COVID-19 infection by PCR within 7 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. 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

  1. Requirement for hospital admission
  2. 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.
  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
    5. Known cirrhosis with any history of decompensation (ascites, variceal bleeding or hepatic encephalopathy)
    6. Known chronic kidney disease with estimated creatinine 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 alcohol or drug dependence that in the opinion of the investigator would impair study participation
  7. Known prior intolerance to interferon treatment
  8. Enrolment in another clinical trial with use of any investigational agent in the prior 30 days
  9. 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 10 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. 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

  1. Severity of illness

    1. Respiratory failure (requiring>6L O2 or intubation in the ER)
    2. Shock - systolic BP<90 mmHg or mean arterial BP<60 mmHg after fluid resuscitation
  2. Pregnancy (or positive urine pregnancy test) or lactating
  3. 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 cirrhosis with any history of decompensation (ascites, variceal bleeding or hepatic encephalopathy)
    5. Known chronic kidney disease with estimated creatinine clearance < 30 mL/minute or need for dialysis
    6. Severe psychiatric disorder - uncontrolled schizophrenia, bipolar disorder, depression with prior suicidality
    7. 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
  4. Known prior intolerance to interferon treatment
  5. Enrolment in another clinical trial with use of an antiviral agent in the prior 30 days (co-enrollment with immunomodulatory agents permitted)
  6. Use of off-label therapy for COVID-19
  7. 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 < 30 cc/mL
    5. Total bilirubin > 2x upper limit of normal (ULN)
    6. Alanine aminotransferase (ALT) > 5x ULN
    7. Aspartate aminotransferase (AST) > 5x ULN
    8. Lipase or amylase > 2x ULN
    9. Random blood glucose > 20 mmol/L

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jordan Feld, MD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2020

Primary Completion (Actual)

August 19, 2022

Study Completion (Actual)

December 8, 2022

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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.

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