Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients

Medical College of Wisconsin131 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

131

Conditions

COVID-19

Interventions

anti-SARS-CoV-2 convalescent plasmaBIOLOGICAL

* 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years or older 2. Hospitalized as an in-patient with positive COVID-19 test by PCR 3. 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 4. Patient / HCPOA must agree to storage of blood specimens for future testing. 5. 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. 6. Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted. Exclusion Criteria: 1. FCBP with positive pregnancy test (mandatory) 2. Breastfeeding females 3. Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies . 4. Mechanical ventilation for \> 14 days 5. Days from symptom onset \>21 days 6. Expected survival \< 72 hours 7. Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI 8. 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 .

Locations (1)

Froedtert Hospital

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Overall Mortality

Overall mortality during hospitalization for COVID-19. All patients were followed for the duration of their hospitalization, sometimes exceeding 60 days, through study completion.

Time frame: Duration of patient hospitalization, sometimes exceeding 60 days

Secondary Outcomes

Length of Admission After Plasma Infusion

Length of admission after convalescent plasma infusion for all patients. All enrolled patients, whether they were in the ICU cohort or in the non-ICU cohort, were monitored from the time of consent until the time of hospital discharge. Hospital discharge includes those patients who left the hospital alive and those patients who died during their stay.

Time frame: Length of admission for COVID through study follow-up period

Length of ICU Stay After Convalescent Plasma Infusion

Length of ICU stay after plasma infusion for patients who were in the experimental ICU cohort

Time frame: Length of admission in the ICU for COVID through study follow-up period

Data from ClinicalTrials.gov

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