Principal Investigator: Rob Singleton
Keywords: Clinical Trials , COVID-19 , Coronavirus Department: Neurology
IRB Number: 00136298
Specialty: Internal Medicine, General
Sub Specialties:
Recruitment Status: Active, not recruiting

Contact Information

Evan Heller
evan.heller@hsc.utah.edu
801-587-6293

Brief Summary

Primary Efficacy Objective: Evaluate the efficacy of treatment at Day 28 following high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19 at day 28.

Primary Endpoint:
Cumulative incidence of development of COVID-19 disease (symptoms compatible with infection and/or + molecular testing) regardless of disease severity.

Primary Safety Objective: Evaluate the safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19

Primary Safety Endpoints:
1. Cumulative incidence of serious adverse events categorized separately as either severe infusion reactions and ARDS during the study period
2. Cumulative incidence of grade 3 and 4 adverse events during the study period

Secondary Objectives:
1. Cumulative incidence of disease severity between the anti-SARS-CoV-2 convalescent plasma and control groups after individuals develop SARS-CoV-2 infection. Severity of disease will be measured using a clinical event scale of disease severity (evaluated up to Day 28):

1. Death
2. Requiring mechanical ventilation and/or in ICU
3. non-ICU hospitalization, requiring supplemental oxygen;
4. non-ICU hospitalization, not requiring supplemental oxygen;
5. a stay of >24 hours for observation in an ED, field hospital, or other healthcare unit*
6. any receipt of O2 for >24 hours, outside of hospital*
7. Not hospitalized, but with clinical and laboratory evidence2 of COVID-19 infection

    Other Objectives:
    1. Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 nonimmune plasma) groups’ anti-SARS-CoV-2 titers at days -1 to 0, 1, 7, 14 and 90.
    2. Compare the rates and duration of SARS-CoV-2 molecular testing positivity amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 1, 7, 14 and 28
    3. Compare the levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days -1 to 0, 1, 7, 14 and 28

    Inclusion Criteria

    1. Subjects must be 18 years of age or older

    2. Close contact* exposure to person with COVID-19 within 96 hours of enrollment (and 120 hours of receipt of plasma) defined as:

    2.1 Living in the same household as, being an intimate partner of, or providing care in a nonhealthcare setting (such as a home) for a person with symptomatic laboratory-confirmed COVID-19 infection without using recommended precautions for home care and home isolation

    2.2 HCP who have had prolonged close contact with patients with COVID-19 who were not wearing a facemask while HCP nose and mouth were exposed to material potentially infectious with the virus causing COVID-19.

    2.3 Being present in the room for procedures that generate aerosols or during which respiratory secretions are likely to be poorly controlled (e.g., cardiopulmonary resuscitation, intubation, extubation, bronchoscopy, nebulizer therapy, sputum induction) on patients with COVID-19 when the healthcare providers’ eyes, nose, or mouth were not protected

    Exclusion Criteria

    1. Receipt of any blood product in past 120 days

    2. Medical, psychiatric, cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance

    3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening

    4. Laboratory evidence of COVID-19 infection at time of screening

    5. History or known laboratory evidence of previous COVID-19 infection

    6.  Receipt of SARS-CoV-2 Vaccine

    6. History of prior reactions to transfusion blood products

    7. inability to complete therapy with the study product within 24 hours after enrollment

     

    Please see section 4 "Study Information" for details on vaccines in study subjects