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

NO_LONGER_AVAILABLE

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04358211

Run by

Nakhle Saba, MD

Last updated by the study team

2021-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Population 1: Associated Severe Pulmonary Complications
• 18 years or older.
• Hospitalized and intubated in the ICU with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements, or requirement for informed consent is WAIVED due to the inability to communicate with the patient and unable to identify legally authorized representative.
• Consents to storage of specimens for future testing, or consent waived.
• The requirements to waive a consent are delineated in 21 CFR 50.23 and will be followed.
• Pregnant and breastfeeding women will not be excluded from the study.
• Population 2: Coronavirus Associated Complications in hospitalized patients
• 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.

You may not qualify if…

• Population 1:
• Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
• Severe multi-organ failure with expected life expectancy < 24h as determined by the treating physician.
• Population 2:
• 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.

Where it is running

• Tulane Medical Center — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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