A Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.

Detailed Description
-----------------
This is an open label phase 2 trial assessing the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute severe respiratory symptoms from COVID-19. Symptomatic patients with clinical or radiological interstitial COVID-19 pneumonia and within 21 days of onset of symptoms will be enrolled in 2 cohorts - an ICU cohort and a hospitalized non-ICU cohort.

Official Title
-----------------
An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: anti-SARS-CoV-2 convalescent plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years or older Hospitalized as an in-patient with positive COVID-19 test by PCR Presence of respiratory symptoms with any of severe features as below: Respiratory Rate ≥ 24/min Oxygen Support >3L/min by nasal cannula New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause Patient / HCPOA must agree to storage of blood specimens for future testing. Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient. Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted. Exclusion Criteria: FCBP with positive pregnancy test (mandatory) Breastfeeding females Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies . Mechanical ventilation for > 14 days Days from symptom onset >21 days Expected survival < 72 hours Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 131 patients in 2 cohorts (ICU cohort and a hospitalized non-ICU cohort)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICU Cohort<br>Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. | Biological: anti-SARS-CoV-2 convalescent plasma<br>* SARS-CoV-2 convalescent plasma (1-2 units;  200-400 mL maximum dose as 7 ml/kg adjusted IBW ) Study drug will be administered as a single intravenous infusion<br>|
| Experimental: Non-ICU Cohort<br>Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. | Biological: anti-SARS-CoV-2 convalescent plasma<br>* SARS-CoV-2 convalescent plasma (1-2 units;  200-400 mL maximum dose as 7 ml/kg adjusted IBW ) Study drug will be administered as a single intravenous infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Mortality within 60 days | Overall mortality within 60 days | sixty days from infusion of plasma | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU stay during current admission for COVID | length of admission for COVID | Length of admission for COVID through study follow-up period, an average of 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19