Last updated 17 days ago
Outpatient Treatment With Anti-Coronavirus Immunoglobulin
820 patients around the world
Available in Mexico, United States, Spain, Argentina
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.
University of Minnesota
10Research sites
820Patients around the world
This study is for people with
Covid-19
Covid-19 vaccines
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 daysRheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapyAntirejection medicine after solid organ or stem cell transplantationCancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 monthsPrimary or acquired severe B- or T-lymphocyte immune dysfunctionHIV infectionSplenectomy or functional asplenia
- 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 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.
Sites
Hospital General de Agudos J. M. Ramos Mejía - Buenos Aires, CABA
Recruiting
Instituto Médico Platense SA - La Plata
Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Dr. Salvador Zubirán
Recruiting
Hospital General Dr. Aurelio Valdivieso
Recruiting
CHRISTUS Centro de Excelencia en Investigación - CEI (Obispado)
Recruiting
Hospital General Dr. Manuel Gea González
Recruiting
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Recruiting
Hospital Universitario Germans Trias i Pujol
Recruiting
CAP Can Bou
Recruiting
CAP El Maresme (Gatassa)
Recruiting
StudyOTAC
SponsorUniversity of Minnesota
Study typeInterventional
Conditions
Covid-19 vaccines
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04910269
