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.
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 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. The purpose of this trial is to provide
expanded access to SARSCoV2 convalescent plasma (EAP) collected from matched donors as
described to patients with severe or life-threatening illness owing to COVID-19.
Biological: SARSCoV2 Convalescent Plasma
Provide expanded access to SARSCoV2 convalescent plasma (EAP) collected from matched donors as described to patients with severe or life-threatening illness owing to COVID-19.
Inclusion Criteria:
- 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:
1. dyspnea
2. respiratory frequency ≥ 30/min
3. blood oxygen saturation ≤ 93%
4. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or
5. lung infiltrates > 50% within 24 to 48 hours
Life-threatening disease is defined as:
6. respiratory failure
7. septic shock, and/or
8. multiple organ dysfunction or failure
Exclusion Criteria:
- Known contraindication to transfusion or history of prior reactions to transfusion of
blood products
AdventHealth Orlando
Orlando, Florida, United States
Eduardo Oliveira, MD, Principal Investigator
AdventHealth