Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
86 participants
INTERVENTIONAL
2020-06-01
2023-03-23
Brief Summary
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Detailed Description
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The research hypothesis is that COVID-19 convalescent plasma (CCP) transfusion improves outcomes in patients with COVID-19.
The use of CCP to treat serious and life threatening COVID-19 has a sound biological as well as clinical rationale to provide virus-specific immune protection in patients unable to produce and/or maintain antiviral antibodies. This treatment protocol is designed primarily to offer a rescue therapy in patients with severe and life threatening disease and explore use in patients for whom a progression to serious disease is likely. Examining the specific antibody responses to the virus in transfused patients if/when they show signs of recovery and comparing these values with those obtained before the transfusion may provide information to design more extensive trials aimed at identifying the best patient population for future use of CCP.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
Transfusion of COVID-19 convalescent plasma to participants with serious or life threatening complications from COVID-19 or are at high risk to develop serious complications.
COVID Convalescent Plasma
One unit of COVID Convalescent Plasma transfused on Day 0
Interventions
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COVID Convalescent Plasma
One unit of COVID Convalescent Plasma transfused on Day 0
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinician judged serious or life threatening COVID-19 (or at significant risk to develop serious COVID) manifested by at least one of the following:
1. Laboratory confirmed diagnosis of SARS-CoV-2 infection
2. Hypoxia (PaO2/FiO2 \<300, Pulse oximetry \<93% at rest
3. Evidence of pulmonary infiltration
4. Respiratory failure
5. Sepsis
6. Multiple organ dysfunction or failure (assessed by SOFA score)
3. Informed consent provided by the patient or legally authorized representative (LAR)
Exclusion Criteria
2. Receipt of pooled immunoglobulin transfusion in previous 28 days
3. History of prior reaction to transfused blood products
4. Currently enrolled in other drug trials that preclude investigational treatment with CoV-2 convalescent plasma transfusion
18 Years
ALL
No
Sponsors
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University of Mississippi Medical Center
OTHER
Gailen D. Marshall Jr., MD PhD
OTHER
Responsible Party
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Gailen D. Marshall Jr., MD PhD
Vice Chair for Research, Department of Medicine; Director, Division of Allergy, Asthma and Clinical Immunology
Principal Investigators
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Gailen D Marshall, Jr., MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Mississippi Medical Center
Locations
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University of Mississippi Medical Center
Jackson, Mississippi, United States
Countries
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References
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Syal K. COVID-19: Herd immunity and convalescent plasma transfer therapy. J Med Virol. 2020 Sep;92(9):1380-1382. doi: 10.1002/jmv.25870. Epub 2020 Jul 11. No abstract available.
Xu Z, Li S, Tian S, Li H, Kong LQ. Full spectrum of COVID-19 severity still being depicted. Lancet. 2020 Mar 21;395(10228):947-948. doi: 10.1016/S0140-6736(20)30308-1. Epub 2020 Feb 14. No abstract available.
Luke TC, Kilbane EM, Jackson JL, Hoffman SL. Meta-analysis: convalescent blood products for Spanish influenza pneumonia: a future H5N1 treatment? Ann Intern Med. 2006 Oct 17;145(8):599-609. doi: 10.7326/0003-4819-145-8-200610170-00139. Epub 2006 Aug 29.
Wong SS, Yuen KY. The management of coronavirus infections with particular reference to SARS. J Antimicrob Chemother. 2008 Sep;62(3):437-41. doi: 10.1093/jac/dkn243. Epub 2008 Jun 18.
Mo Y, Fisher D. A review of treatment modalities for Middle East Respiratory Syndrome. J Antimicrob Chemother. 2016 Dec;71(12):3340-3350. doi: 10.1093/jac/dkw338. Epub 2016 Sep 1.
van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.
Ye Q, Wang B, Mao J. The pathogenesis and treatment of the ;Cytokine Storm' in COVID-19. J Infect. 2020 Jun;80(6):607-613. doi: 10.1016/j.jinf.2020.03.037. Epub 2020 Apr 10.
Jiang S, Hillyer C, Du L. Neutralizing Antibodies against SARS-CoV-2 and Other Human Coronaviruses. Trends Immunol. 2020 May;41(5):355-359. doi: 10.1016/j.it.2020.03.007. Epub 2020 Apr 2.
Related Links
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Clinical Trials at UMMC - CCP Transfusion Study
Other Identifiers
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2020-0137
Identifier Type: -
Identifier Source: org_study_id