SARSCoV2 (COVID-19) Convalescent Plasma (CP) Expanded Access Protocol (EAP)
NO_LONGER_AVAILABLE
Conditions studied: COVID, SARSCoV2 Convalescent Plasma
In brief
Convalescent plasma has been administered to treat different infectious diseases previously with some success. There is currently no approved and proven treatment options available for the novel coronavirus disease (COVID-19 virus). Some early data has shown a potential benefit in treating hospitalized patients who have tested positive for COVID-19 with convalescent plasma infusions of fresh plasma donated by fully recovered COVID-19 patients. The antibodies present in the recovered patients' plasma may be of benefit in helping critically ill and infected patients recover from the COVID-19 virus.
Key facts
- Study ID
- NCT04374370
- Run by
- AdventHealth
- Last updated by the study team
- 2021-05-06
Who can join
Age: 6 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ages 6 and up
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age); or willing and able to provide assent as required per Institutional Review Board (IRB) prior to performing study procedures.
- Must have laboratory confirmed COVID-19 positive test
- Must have severe or immediately life-threatening COVID-19
- Severe disease is defined as:
- dyspnea
- respiratory frequency ≥ 30/min
- blood oxygen saturation ≤ 93%
- partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or
- lung infiltrates > 50% within 24 to 48 hours
- Life-threatening disease is defined as:
- respiratory failure
- septic shock, and/or
- multiple organ dysfunction or failure
You may not qualify if…
- Known contraindication to transfusion or history of prior reactions to transfusion of blood products
Where it is running
- AdventHealth Orlando — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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