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

NCT04374370 | Unknown

• 1 other identifier: 1596191
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID; SARSCoV2 Convalescent Plasma

Interventions

SARSCoV2 Convalescent Plasma BIOLOGICAL

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.

Eligibility Criteria

• Age: 6 Years - 99 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Related Publications (3)

• 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.

  PMID: 32167489 BACKGROUND

• 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.

  PMID: 32253318 BACKGROUND

• 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.

  PMID: 32219428 BACKGROUND

Study Officials

• Eduardo Oliveira, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

US (1)