Expanded Access to Convalescent Plasma to Treat and Prevent Pulmonary Complications Associated Wi… (NCT04358211) | Clinical Trial Compass
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Expanded Access to Convalescent Plasma to Treat and Prevent Pulmonary Complications Associated With COVID-19
United States
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
Exclusion Criteria:
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/breas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.