Convalescent Plasma to Limit Coronavirus Associated Complications

Study Overview
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Brief Summary
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Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.

Detailed Description
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High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients. An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.

Official Title
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Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19

Conditions
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Coronavirus

Intervention / Treatment
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* Biological: 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. Patient is willing and able to provide written informed consent and comply with all protocol requirements. Patient agrees to storage of specimens for future testing. Exclusion Criteria: Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period Receipt of pooled immunoglobulin in past 30 days Contraindication to transfusion or history of prior reactions to transfusion blood products

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Convalescent Plasma Group<br>Subjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of >1:64. | Biological: Convalescent Plasma<br>* Anti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers >1:64.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RNA in SARS-CoV-2 | Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time. | Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion | 
| ICU Admissions | Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion. | 90 days after transfusion | 
| Hospital Mortality | Total number of subject deaths. | 90 days after transfusion | 
| Hospital Length of Stay (LOS) | The total number of days subjects were admitted to the hospital. | 90 days after transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of respiratory support | The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time. | 90 days after transfusion or until hospital discharge (whichever comes first) | 
| Duration of respiratory support | The total number of days subjects required respiratory support. | 90 days after transfusion or until hospital discharge (whichever comes first) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2019 novel Coronavirus, SARS-CoV-2, COVID-19