Outpatient Treatment With Anti-Coronavirus Immunoglobulin

ID#: NCT04910269

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: August 06, 2021

End Date: August 01, 2023

Contact Information:
Gary Collins
612-626-9006
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.
Eligibility:

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

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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