Intermediate IND Severe Illness COVID-19 CP

Study Overview
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Brief Summary
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Beyond supportive care, there are currently no proven therapeutic options for pneumonia due to coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and will be available when sufficient numbers of people have recovered. Such persons should have high titer neutralizing immunoglobulin-containing plasma.

Detailed Description
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Subjects will receive open-label screened plasma from COVID-19+ clinically resolved individuals (≥14 days post-resolution). Dosing of single or double plasma units (weight based < and > 90Kg) will be administered on days 0, 2, 4, 6, and 8 (based on plasma availability), or until futility (if either occurs before day 8) is determined by the ICU. Doses can be omitted at the discretion of the treating clinician (e.g., TRALI events are 100% donor-dependent and do not prohibit future transfusions). The study drug is the investigational product, anti-SARS-CoV-2 convalescent plasma obtained from the American Red Cross or local plasma supply (medicDal center or city/region-wide shared blood bank) from patients identified as having recovered from COVID-19. Donors and samples will be screened for infections transmitted via transfusion (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T.cruzi, ZIKV) both through the use of the uniform donor questionnaire and FDA mandated blood donor screening tests. Plasma will be collected using apheresis technology or whole blood collection in accordance with standard FDA and blood bank protocols.

Official Title
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Intermediate IND Severe Illness COVID-19 CP

Conditions
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Severe Acute Respiratory Syndrome, COVID

Intervention / Treatment
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* Drug: SARS-CoV-2 plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Laboratory confirmed COVID-19 Severe or Immediately life threatening COVID-19 Dyspnea Respiratory frequency > 30/minute Blood oxygen saturation <93% Life-threatening disease is defined as the following Respiratory Failure. Septic shock, and/or, Multiple organ dysfunction or failure. Exclusion Criteria: Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products). Other documented uncontrolled infection. Severe DIC needing factor replacement, FFP, cryoprecipitate. On dialysis. Active intracranial bleeding. Clinically significant myocardial ischemia.

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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Severely ill patients with COVID-19 severe respiratory distress
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Convalescent Plasma<br>SARS-CoV-2 convalescent plasma from approved donors will be transfused into severely ill patients with confirmed COVID-19 severe respiratory distress. Plasma will be administered on days 0, 2,4, 6 and 8. | Drug: SARS-CoV-2 plasma<br>* To determine feasibility of convalescent plasma for treating patients in the ICU with COVID-19.<br>* Other names: Convalescent plasma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion of patients in the ICU with convalescent plasma for COVID-19-induced respiratory failure. | Identification of patient population in ICU that are in acute respiratory failure due to COVID-19 and transfuse with convalescent plasma | Track patient progress for 28 days post initial convalescent dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilatory free days | Measure reduction in ventilator use and/or changes in mechanical ventilator parameters | Track patient progress for 28 days post initial convalescent dose. | 
| Patient mortality (including death from any cause) | Measure length of stay from the time of admission to the hospital and subsequent admission to the ICU. Document resolution of COVID-19 infection or alternatively patient death. | Track patient progress for 28 days post initial convalescent dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corona Virus, Convalescent plasma