Expanded Access to Convalescent Plasma to Treat and Prevent Pulmonary Complications Associated With COVID-19

Overview

I. Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in 1. intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT. 2. hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19. II. Study Population: 1. Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older. 2. Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness. III. Study Agent: SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL at neutralization antibody titer \>1:160.

There are currently no proven safe and efficacious treatment for COVID-19. While most patients recover on their own with basic measures at home, around 20% suffer a more aggressive disease requiring hospitalization, of which 5% necessitating intensive care unit (ICU) admission and potential invasive breathing support. The wide spectrum of COVID 19 also include a significant number of totally asymptomatic patients who are unknowingly spreading the disease. Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. This convalescent plasma could be beneficial, not only for severely ill and intubated patients, but also for those with moderate disease early in their disease course to prevent further disease progression and ICU admission. I. Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in 1. intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT. 2. hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19. II. Study Population: 1. Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older. 2. Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness. III. Study Duration: April 3, 2020 to December 31, 2022. IV. Study Agent: SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL at neutralization antibody titer \>1:160. (Note this is a moving target as assays develop)). Product will be produced using Blood Bank of New Orleans and safety procedures and procured from patients who have been symptom free for 14 days and screen negative via NP swab or any other test that emerges in the meantime. Doors who have been symptoms free for more than 28 days are eligible to donate without the need of a NP swab. Any emerging FDA guidance will be followed.

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Eligibility

Locations (1)