Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19

Study Overview
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Brief Summary
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This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.

Detailed Description
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Primary objectives are as follows: To provide access to treatment with investigational convalescent plasma to inpatients with documented COIVD-19 infection To measure NAb titers in an aliquot of the CP administered, to measure the volume of CP administered, and determine whether there is a correlation between the NAb dose (in NAb units/kg body weight, where a unit is the reciprocal of the endpoint NAb titer in the CP multiplied by the volume in ml) and change or lack of change when comparing pre-treatment and day one NAb titers. Secondary, exploratory objectives are as follows: To evaluate the safety of convalescent plasma (CP) administration in hospitalized COVID-19 patients To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on days 3, 7, and 14 after CP transfusion To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment with CP transfusion Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory support, LOS, and mortality)

Official Title
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Open, Non-comparative Pilot Study to Provide Access to Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Convalescent Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be 18 years of age or older. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment, test results must be positive prior to administration of convalescent plasma. Patient (or legally authorized representative, LAR) is willing and able to provide written informed consent and comply with all protocol requirements. For patients unable to consent, consent by the legally authorized representative (LAR) may be obtained by phone. Exclusion Criteria: Female subjects with positive pregnancy test or breastfeeding. Receipt of pooled immunoglobulin in past 30 days. Contraindication to transfusion or history of prior severe allergic reactions to transfused blood products. On ECMO or in refractory shock at entry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Convalescent Plasma<br>The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma. | Drug: Convalescent Plasma<br>* Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.<br>* Other names: Not appicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection | Neutralizing antibody titer (PRNT 80) | Day of convalescent plasma infusion (day 0) and following day (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score | World Health Organization ordinal scale, with scores defined as follows: 5, hospitalized, requiring any supplemental oxygen; 6, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 7, hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation; and 8, death. | Within 4 hours of transfusion | 
| Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples |  | Day 0,1,3,7 and 14 |