COVID-19 Convalescent Plasma (CCP) Transfusion

COVID-19 Clinical Trial

Official title:

An Open Label Trial of Transfusion of COVID-19 Convalescent Plasma (CCP) to Patients With Moderate to Severe COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412486
• Other study ID #: 2020-0137
• Status: Completed
• Phase: Early Phase 1
• Start date: June 1, 2020
• Est. completion date: March 23, 2023

Study information

• Verified date: November 2023
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study evaluates the safety and effectiveness for the use of convalescent plasma transfusion as a treatment option for novel coronavirus SARS-CoV-2 infection (COVID-19). Donors who have recovered from COVID-19 with high antibody levels to the CoV-2 virus will donate plasma at a Mississippi Blood Services facility. Recipients with COIVD-19 who have severe or life threatening conditions will receive plasma from those persons who have recovered from COVID-19.

Description:

The research purpose is to evaluate the safety and clinical effectiveness of transfusing one unit of banked plasma obtained from patients who have recovered from the novel coronavirus SARS-C0V-2 infection with high titers of IgG antibody to this virus transfused into patients with severe or at high risk of progressing to severe coronavirus-induced disease (COVID-19).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18

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:

1. Greater than 21 days from confirmed COVID-19 diagnosis

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• COVID Convalescent Plasma
One unit of COVID Convalescent Plasma transfused on Day 0

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Gailen D. Marshall Jr., MD PhD	University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Erratum In: Trends Immunol. 2020 Apr 24;: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PaO2/FiO2 after CCP transfusion.	Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by PaO2/FiO2.	3 Days
Primary	Change in pulse oximetry status after CCP transfusion.	Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by pulse oximetry.	3 Days
Primary	Change in aO2 after CCP transfusion.	Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by aO2.	3 Days
Primary	Change in respiratory rate after CCP transfusion.	Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by respiratory rate.	3 Days
Primary	Change in intubation status after CCP transfusion.	Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by intubation status.	3 Days
Secondary	Change in Sequential Organ Failure Assessment (SOFA).	Change in SOFA score pre-transfusion to Days 1, 3, 7, and 28 post-transfusion.	Days 1, 3, 7, and 28
Secondary	Change in 8-point ordinal clinical deterioration scale.	Change in 8-point ordinal clinical deterioration scale pre-transfusion to Days 1, 3, 7, and 28 post-transfusion. The 8-point ordinal scale measured by: 8-death, 7-ventilation in addition to ECMO, CRRT and/or vasopressor; 6-intubation and mechanical ventilation; 5-non-invasive mechanical ventilation or high flow oxygen 4- supplemental oxygen by mask or nasal cannula; 3- hospitalization without supplemental oxygen; 2- limitation of activities and 1- no limitation of activities, discharge from hospital.	Days 1, 3, 7, and 28
Secondary	Length of ICU/hospital stay.	Total length of stay in ICU/hospital.	Days 1, 3, 7, and 28
Secondary	Development of plasma transfusion reactions.	Presence of any signs or symptoms of plasma transfusion reactions at Days 1, 3, 7, and 28 post-transfusion.	Days 1, 3, 7, and 28
Secondary	Development of immune complex disorders.	Presence of any signs or symptoms of immune complex disorders (fever spike, urticarial lesion, arthralgias, myalgias, hematuria, non IgE-mediated anaphylaxis) at Days 1, 3, 7, and 28 post-transfusion.	Days 1, 3, 7, and 28
Secondary	Change in anti CoV-2 IgM and IgG levels.	Change in anti CoV-2 IgM and IgG levels pre-transfusion compared to levels on Days 1, 3, 7, and 28 post-transfusion.	Days 1, 3, 7, and 28

External Links

•   Clinical Trials at UMMC - CCP Transfusion Study