Convalescent Plasma to Limit Coronavirus Associated Complications

Mayo Clinic

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Coronavirus

Interventions

Convalescent PlasmaBIOLOGICAL

Anti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers \>1:64.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 90 days after transfusion

Hospital Mortality

Total number of subject deaths.

Time frame: 90 days after transfusion

Hospital Length of Stay (LOS)

The total number of days subjects were admitted to the hospital.

Time frame: 90 days after transfusion

Secondary Outcomes

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.

Time frame: 90 days after transfusion or until hospital discharge (whichever comes first)

Duration of respiratory support

The total number of days subjects required respiratory support.

Time frame: 90 days after transfusion or until hospital discharge (whichever comes first)

Data from ClinicalTrials.gov

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