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SARSCoV2 (COVID-19) Convalescent Plasma (CP) Expanded Access Protocol (EAP)

Studies

Study First Submitted Date 2020-05-01
Study First Posted Date 2020-05-05
Last Update Posted Date 2021-05-06
Verification Month Year May 2021
Verification Date 2021-05-31
Last Update Posted Date 2021-05-06

Detailed Descriptions

Sequence: 20632732
Description 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.

Facilities

Sequence: 199157113
Name AdventHealth Orlando
City Orlando
State Florida
Zip 32803
Country United States

Conditions

Sequence: 51941656 Sequence: 51941657
Name COVID Name SARSCoV2 Convalescent Plasma
Downcase Name covid Downcase Name sarscov2 convalescent plasma

Id Information

Sequence: 39980618
Id Source org_study_id
Id Value 1596191

Countries

Sequence: 42371974
Name United States
Removed False

Interventions

Sequence: 52254021
Intervention Type Biological
Name SARSCoV2 Convalescent Plasma
Description 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.

Sponsors

Sequence: 48104068
Agency Class OTHER
Lead Or Collaborator lead
Name AdventHealth

Overall Officials

Sequence: 29153530
Role Principal Investigator
Name Eduardo Oliveira, MD
Affiliation AdventHealth

Eligibilities

Sequence: 30629877
Gender All
Minimum Age 6 Years
Maximum Age 99 Years
Criteria 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: 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 Exclusion Criteria: Known contraindication to transfusion or history of prior reactions to transfusion of blood products
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254075862
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 6
Maximum Age Num 99
Minimum Age Unit Years
Maximum Age Unit Years

Responsible Parties

Sequence: 28744220
Responsible Party Type Sponsor

Study References

Sequence: 51825471 Sequence: 51825472 Sequence: 51825473
Pmid 32167489 Pmid 32253318 Pmid 32219428
Reference Type background Reference Type background Reference Type background
Citation Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available. Citation Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6. Citation Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.