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Outpatient Treatment With Anti-Coronavirus Immunoglobulin
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.
Study details:
The primary objective will be addressed by testing two hypotheses aimed at assessing whether hIVIG + standard of care (SOC) is superior to placebo + SOC for the primary ordinal endpoint at Day 7. These hypotheses will be tested for the following two groups: a) among all randomized participants (stratum 1 and 2), and b) among only participants enrolled in stratum 1. For the primary analysis, overall type 1 error will be controlled at 5% by using a 2-sided significance level of 0.
035 for each hypothesis. This significance level was obtained using the correlation between the test statistics for the proportional log odds ratio for all randomized participants and for this log odds ratio for those in stratum 1. This correlation was determined to be 0.
895. With this approach hIVIG will be considered superior to placebo if either of the two hypotheses is rejected. Participants will be randomized to a single infusion of an hIVIG product or placebo in a 1:1 allocation.
Randomization will be stratified by study site pharmacy and the two SOC strata.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-08-06
Primary completion: 2026-08-01
Study completion finish: 2026-08-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT04910269
Intervention or treatment
BIOLOGICAL: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)
OTHER: Placebo
Conditions
- • COVID
- • SARS-CoV2 Infection
- • Covid19
Find a site
Closest Location:
St. Vincent's Hospital
Research sites nearby
Select from list below to view details:
St. Vincent's Hospital
Sydney, New South Wales, Australia
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?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Treatment Group
| BIOLOGICAL: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)
|
PLACEBO_COMPARATOR: Placebo Group
| OTHER: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Clinical Status | 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 | 7 days |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
All-cause hospitalization or death through 28 days. | Outcome reported as the percent of participants who are hospitalized or who expire for any reason by day 28 post treatment. | 28 days |
All-cause mortality through 28 days. | Outcome reported as the percent of participants who expire for any reason by day 28 post treatment. | 28 days |
Significant Disease Progression | 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. | 28 days |
Ordinal Scale Distribution | 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 | 4, 14, 28 days |
Disease Progression Through 7 Days | 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. | 7 days |
Significant Disease Progression Through 7 Days | 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. | 7 days |
Disease Progression at Follow-up | 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. | 7, 14, 28 days |
Activity Limitations at Follow-up | 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. | 7, 14, 28 days |
Change in Viral Burden from Serum Antigen | 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. | 7 days |
Change in Viral Burden from PCR | 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. | 7 days |
Change in SARS-CoV-2 Antibody Concentration | Outcome is reported as the change in SARS-CoV-2 antibody levels between Day 0 and Day 7, including subclasses and neutralizing titers. | 7 days |
Healthcare Utilization at Follow-up | 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. | 28 days |
Worst Status Through 28 Days | 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). | 28 days |
Hypoxemia Through Day 7 | Outcome is reported as the mean oxygen saturation (percentage) level in each group at 7 days. | 7 days |
Additional COVID-19 Treatment | Outcome is reported as the number of patients starting other treatments targeting COVID-19 through 28 days post treatment. | 28 days |
Frequently Asked Questions
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