Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis

COVID-19 Clinical Trial

— PLASMA  

Official title:

Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis / Plasmaféresis terapéutica en Pacientes Adultos críticamente Enfermos Con diagnóstico Confirmado de COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04480632
• Other study ID #: CEI-2020-01200
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: August 2022

Study information

• Verified date: July 2020
• Source: Fundación Cardiovascular de Colombia
• Contact: Norma Serrano, MD
• Phone: 3102740099
• Email: normaserrano[@]fcv.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: The SARS-CoV-2 outbreak has left more than two million infected worldwide in the first four months of COVID-19 epidemic. To date, there is no specific treatment for the disease and in critically ill patients there is an additional challenge in controlling the systemic inflammatory response, which is characterized by cytokine storm, alteration in coagulation and endothelial activation in addition to infection. Strategies used in previous viral epidemics, such as convalescent plasma, are therapeutic options to rescue, especially in individuals with a critical presentation of the disease.

Aim: To establish clinical response of critically ill patients with COVID-19 who received convalescent plasma from subjects recovered from SARS-CoV-2 during their stay in Intensive Care Unit at Fundación Cardiovascular de Colombia (Hospital Internacional de Colombia).

Methodology: Quasi-experimental study (no randomization will be performed). Adult patients who meet selection criteria will receive 500 ml of ABO compatible convalescent plasma, obtained by apheresis from patients recovered from SARS-CoV-2 infection. The main outcome will be in-hospital mortality at 30 days, while indication for ventilatory support (intubation) and adverse events at thirty days will be evaluated as secondary outcomes, compared to subjects receiving usual treatment for clinical sign and symptoms given the absence of ABO compatible plasma units. A survival analysis will be performed using Kaplan-Meier method and association strength will be reported using HR and 95% CI crude and adjusted for confounding variables.

Expected results: It is expected to know the clinical and paraclinical response of patients receiving convalescent plasma in our institution, as well as to establish their probability of survival and its associated factors.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: August 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age range: Over 18 years old

• Patients with confirmed infection by COVID-19 (positive real-time PCR) in ICU with:

• Respiratory failure receiving ventilatory support and high parameters

• Severe pneumonia with rapid progression

• Ability to sign informed consent

Exclusion Criteria:

• Pregnant women

• Contraindication of plasma administration due to history of anaphylaxis during transfusions

Related Conditions & MeSH terms

• COVID-19
• Critical Illness

Intervention

Biological:
• Convalescent plasma
ABO compatible convalescent plasma obtained from from recovered COVID-19 patients

Locations

Country	Name	City	State
Colombia	Hospital Internacional de Colombia	Piedecuesta	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Cardiovascular de Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (8)

Ahn JY, Sohn Y, Lee SH, Cho Y, Hyun JH, Baek YJ, Jeong SJ, Kim JH, Ku NS, Yeom JS, Roh J, Ahn MY, Chin BS, Kim YS, Lee H, Yong D, Kim HO, Kim S, Choi JY. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020 Apr 13;35(14):e149. doi: 10.3346/jkms.2020.35.e149. — View Citation

Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. — View 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. — View Citation

Hui DS. Severe acute respiratory syndrome (SARS): lessons learnt in Hong Kong. J Thorac Dis. 2013 Aug;5 Suppl 2:S122-6. doi: 10.3978/j.issn.2072-1439.2013.06.18. — View Citation

Keith P, Day M, Perkins L, Moyer L, Hewitt K, Wells A. A novel treatment approach to the novel coronavirus: an argument for the use of therapeutic plasma exchange for fulminant COVID-19. Crit Care. 2020 Apr 2;24(1):128. doi: 10.1186/s13054-020-2836-4. — View Citation

Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16. Review. — View 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 Mar 27. doi: 10.1001/jama.2020.4783. [Epub ahead of print] — View Citation

Zhang B, Liu S, Tan T, Huang W, Dong Y, Chen L, Chen Q, Zhang L, Zhong Q, Zhang X, Zou Y, Zhang S. Treatment With Convalescent Plasma for Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Chest. 2020 Mar 31. pii: S0012-3692(20)30571-7. doi: 10.1016/j.chest.2020.03.039. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality	In-hospital mortality after administration of ABO compatible convalescent plasma or indication (but not plasmapheresis for absence of compatible convalescent plasma) for comparison group	30 days
Secondary	Incidence of renal replacement therapy	Number of patients with medical indication of hemodialysis or peritoneal dialysis for acute renal failure	30 days
Secondary	Incidece of adverse events	Number of patients with Alergic reaction, Anaphylaxis, Severe thrombotic events, Transfusion-related acute lung injury (TRALI)], Transfusion-associated circulatory overload (TACO)], Antibody-Dependent Enhancement (ADE)]	During tranfusion until 24 hours after.