Outpatient Treatment With Anti-Coronavirus Immunoglobulin (OTAC)

  • STATUS
    Recruiting
  • End date
    Aug 24, 2023
  • participants needed
    820
  • sponsor
    University of Minnesota
Updated on 24 April 2022

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 SARS-CoV-2 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 1 will be participants who receive neutralizing monoclonal antibodies (nMAbs) as standard of care (SOC), estimated to be about 20% of participants. Stratum 2 will be participants who do not receive nMAbs, estimated to be about 80% of participants.

Description

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 (1 of 2) or placebo in a 1:1:2 allocation. After pooling data from each hIVIG product, this will result in 1:1 allocation for hIVIG versus placebo. Randomization will be stratified by study site pharmacy and the two SOC strata.

Details
Condition COVID, SARS-CoV2 Infection, Covid19
Treatment Placebo, Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)
Clinical Study IdentifierNCT04910269
SponsorUniversity of Minnesota
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

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
Steroids equivalent to prednisone > 10 mg/day for at least the last 28 days
Rheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapy
Antirejection medicine after solid organ or stem cell transplantation
Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 months
Primary or acquired severe B- or T-lymphocyte immune dysfunction
HIV infection
Splenectomy or functional asplenia

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
acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization
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 IgA deficiency or anti-IgA antibodies
Medical conditions for which receipt of a 300 mL volume of IV fluid from study treatment may pose specific risk to the patient (e.g., decompensated congestive heart failure)
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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