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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04910269
Registration number
NCT04910269
Ethics application status
Date submitted
1/06/2021
Date registered
2/06/2021
Titles & IDs
Public title
Outpatient Treatment With Anti-Coronavirus Immunoglobulin
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Scientific title
An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19
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Secondary ID [1]
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2021-001663-24
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Secondary ID [2]
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INSIGHT12
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Universal Trial Number (UTN)
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Trial acronym
OTAC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID
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SARS-CoV2 Infection
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Covid19
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)
Other interventions - Placebo
Experimental: Treatment Group - Participants in this group will receive the investigational treatment in addition to standard of care.
Placebo comparator: Placebo Group - Participants in this group will receive a placebo in addition to standard of care.
Treatment: Other: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)
The hIVIG product is administered as a single dose of 3.5 grams, or 35 milliliter at a concentration of 0.1 grams/milliliter.
Other interventions: Placebo
Infusion of 35 milliliters standard isotonic saline
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical Status
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Assessment method [1]
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The primary outcome is to compare the safety and efficacy of a single infusion of hIVIG versus placebo on clinical status after seven days. Outcome will be reported as the percent of participants who fall into each of 5 clinical status categories as defined below.
1. Asymptomatic and no limitations in usual activity due to COVID-19
2. Mild COVID-19 illness or minor limitations to usual activity
3. Moderate COVID-19 illness and with major limitations to usual activity
4. Severe COVID-19 or serious disease manifestation from COVID-19
5. Critical illness from COVID-19 or Death
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Timepoint [1]
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7 days
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Secondary outcome [1]
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All-cause hospitalization or death through 28 days.
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Assessment method [1]
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Outcome reported as the percent of participants who are hospitalized or who expire for any reason by day 28 post treatment.
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Timepoint [1]
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28 days
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Secondary outcome [2]
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All-cause mortality through 28 days.
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Assessment method [2]
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Outcome reported as the percent of participants who expire for any reason by day 28 post treatment.
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Timepoint [2]
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28 days
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Secondary outcome [3]
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Significant Disease Progression
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Assessment method [3]
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Outcome is reported as the number of participants with significant disease progression through 28 days, which is defined by fulfilling criteria for category 4 or 5 on the ordinal scale using a time to event analysis.
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Timepoint [3]
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28 days
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Secondary outcome [4]
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Ordinal Scale Distribution
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Assessment method [4]
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Outcome will be reported as the percent of participants who fall into each of 5 clinical status categories as defined below at days 4, 14, and 28 following treatment.
1. Asymptomatic and no limitations in usual activity due to COVID-19
2. Mild COVID-19 illness or minor limitations to usual activity
3. Moderate COVID-19 illness and with major limitations to usual activity
4. Severe COVID-19 or serious disease manifestation from COVID-19
5. Critical illness from COVID-19 or Death
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Timepoint [4]
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4, 14, 28 days
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Secondary outcome [5]
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Disease Progression Through 7 Days
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Assessment method [5]
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Outcome is reported as the proportion of participants with any disease progression at Day 7, using a sliding dichotomous scale progression defined by a categorization on the ordinal scale that is worse than the status at entry.
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Timepoint [5]
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7 days
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Secondary outcome [6]
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Significant Disease Progression Through 7 Days
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Assessment method [6]
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Outcome is reported as the proportion of participants who progress to categories 3-5 on the clinical ordinal scale at Day 7 among participants in categories 1 or 2 of the ordinal scale at entry.
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Timepoint [6]
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7 days
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Secondary outcome [7]
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Disease Progression at Follow-up
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Assessment method [7]
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Outcome is reported as the percent of participants who experience severe disease progression during follow-up, defined by the worst health status achieved on the clinical ordinal scale at any point by Day 7, 14, and 28.
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Timepoint [7]
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7, 14, 28 days
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Secondary outcome [8]
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Activity Limitations at Follow-up
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Assessment method [8]
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Outcome is reported as the percent of participants who attain their pre-COVID health status without limitations in usual activity (defined as category 1 on the ordinal scale) at Day 7, 14, and 28.
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Timepoint [8]
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7, 14, 28 days
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Secondary outcome [9]
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Change in Viral Burden from Serum Antigen
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Assessment method [9]
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Outcome is reported as the change between Day 0 and Day 7 in viral burden as determined by serum antigen levels from nasal and saliva specimens.
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Timepoint [9]
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7 days
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Secondary outcome [10]
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Change in Viral Burden from PCR
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Assessment method [10]
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Outcome is reported as the change between Day 0 and Day 7 in viral burden as determined by polymerase chain reaction (PCR) from nasal and saliva specimens.
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Timepoint [10]
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7 days
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Secondary outcome [11]
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Change in SARS-CoV-2 Antibody Concentration
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Assessment method [11]
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Outcome is reported as the change in SARS-CoV-2 antibody levels between Day 0 and Day 7, including subclasses and neutralizing titers.
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Timepoint [11]
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7 days
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Secondary outcome [12]
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Healthcare Utilization at Follow-up
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Assessment method [12]
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Outcome is reported as the percent of participants who had health care engagement for the purposes of medical evaluation and/or management of COVID-19 illness (e.g., via telehealth, clinic, urgent care, emergency room, or hospitalization) at 28 days follow-up.
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Timepoint [12]
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28 days
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Secondary outcome [13]
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Worst Status Through 28 Days
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Assessment method [13]
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Outcome is reported as the number of participants who experience each of the following categories as their worst respiratory status through 28 days, including: a) no respiratory symptoms, b) upper respiratory symptoms, c) lower respiratory symptoms without hypoxia, c) hypoxia requiring conventional oxygen supplementation by nasal canula, d) respiratory failure requiring high-flow oxygen delivery device or non-invasive ventilation, or e) respiratory failure requiring mechanical ventilation or extra-corporeal membrane oxygenation (ECMO).
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Timepoint [13]
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28 days
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Secondary outcome [14]
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Hypoxemia Through Day 7
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Assessment method [14]
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Outcome is reported as the mean oxygen saturation (percentage) level in each group at 7 days.
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Timepoint [14]
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7 days
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Secondary outcome [15]
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Additional COVID-19 Treatment
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Assessment method [15]
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Outcome is reported as the number of patients starting other treatments targeting COVID-19 through 28 days post treatment.
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Timepoint [15]
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28 days
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Eligibility
Key inclusion criteria
* Clinical risk based on age = 55 years or an adult (age = 18 years) with an immunosuppressed condition.
* Positive test for SARS-CoV-2 within =5 days (if >1 test, the first positive is within =5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test.
* Within =5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection.
* Agrees to not participate in another clinical trial for the treatment or management of SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease progression if prior to Day 7 (defined by ordinal category 4 or 5).
* Participant provides written informed consent prior to study procedures, and understands and agrees to adhere to planned study procedures through Day 28.
Ongoing immunosuppressive condition or immunosuppressive treatment, includes:
1. Steroids equivalent to prednisone > 10 mg/day for at least the last 28 days
2. Rheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapy
3. Antirejection medicine after solid organ or stem cell transplantation
4. Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 months
5. Primary or acquired severe B- or T-lymphocyte immune dysfunction
6. HIV infection
7. Splenectomy or functional asplenia
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours).
* Asymptomatic and has received a vaccination for COVID-19 (=1 dose).
* Undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes).
* Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level).
* Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 in the past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, or any IVIG).
* Any of the following thrombotic or procoagulant conditions or disorders:
1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization.
2. prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin III, protein C, or protein S.
* History of hypersensitivity to blood, plasma or IVIG excipients.
* Known immunoglobulin A (IgA) deficiency or anti-IgA antibodies.
* In the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2026
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Actual
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Sample size
Target
820
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St. Vincent's Hospital - Sydney
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment outside Australia
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United States of America
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State/province [1]
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District of Columbia
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Country [2]
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United States of America
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State/province [2]
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Maryland
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United States of America
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State/province [3]
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Michigan
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United States of America
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State/province [4]
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New York
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United States of America
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Texas
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Country [6]
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United States of America
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Washington
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Country [7]
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Argentina
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State/province [7]
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Buenos Aires
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Country [8]
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Denmark
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State/province [8]
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C
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Denmark
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State/province [9]
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N
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Denmark
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Aalborg
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Denmark
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Copenhagen
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Denmark
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Hellerup
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Denmark
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Hvidovre
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Denmark
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State/province [14]
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Kolding
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Greece
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Attica
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India
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Rajasthan
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India
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Chandigarh
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Mexico
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Cdmx
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Mexico
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NL
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Mexico
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OA
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Spain
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Barcelona
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Thailand
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Bangkok
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Thailand
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Khon Kaen
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Thailand
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Nonthaburi
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Uganda
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Entebbe
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Uganda
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Kampala
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Uganda
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Lira
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Uganda
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Masaka
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United Kingdom
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London
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United Kingdom
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Newcastle upon Tyne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Minnesota
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Institute of Allergy and Infectious Diseases (NIAID)
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Address [1]
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Other collaborator category [2]
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Government body
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Name [2]
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National Institutes of Health (NIH)
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
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Address [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of the Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) (INSIGHT 012) trial is to compare the safety and efficacy of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) versus placebo among adults with recently diagnosed severe acute respiratory syndrome - coronavirus 2 (SARS-CoV2) infection who do not require hospitalization. The primary endpoint of this double-blind randomized trial is a five-category ordinal outcome that assesses the participant's clinical status seven days after the infusion of hIVIG or placebo. 1. Asymptomatic and no limitations in usual activity due to COVID-19 2. Mild COVID-19 illness or minor limitations to usual activity 3. Moderate COVID-19 illness and with major limitations to usual activity 4. Severe COVID-19 or serious disease manifestation from COVID-19 5. Critical illness from COVID-19 or Death Two strata of participants will be identified for analysis purposes. Stratum 2 will be participants who receive direct-acting antivirals (DAAs) or other anti-SARS-CoV2 agents that are approved/available and recommended for use as part of standard of care (SOC), estimated to be about 20% of participants. Stratum 1 will be participants who do not receive this agents, estimated to be about 80% of participants.
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Trial website
https://clinicaltrials.gov/study/NCT04910269
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Trial related presentations / publications
Jha A, Barker D, Lew J, Manoharan V, van Kessel J, Haupt R, Toth D, Frieman M, Falzarano D, Kodihalli S. Efficacy of COVID-HIGIV in animal models of SARS-CoV-2 infection. Sci Rep. 2022 Oct 10;12(1):16956. doi: 10.1038/s41598-022-21223-2.
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Public notes
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Contacts
Principal investigator
Name
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Cavan Reilly, PhD
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Address
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University of Minnesota
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Gary Collins
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Address
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Country
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Phone
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612-626-9006
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
A public data set will be made available at the end of the trial.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04910269