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. |