Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19

Infections, Coronavirus Clinical Trial

Official title:

Inactivated Convalescent Plasma as a Therapeutic Alternative in Hospitalized Patients CoViD-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04385186
• Other study ID #: CT01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 20, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2020
• Source: National Blood Center Foundation, Hemolife
• Contact: Andrés F Zuluaga, MD, MSc, MeH
• Phone: 3014020291
• Email: andres.zuluaga[@]udea.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.

Description:

This study consists of obtaining convalescent plasma by means of apheresis, from recovered donors, who meet the eligibility criteria to donate. Then this plasma will be inactivated by riboflavin and UV based photochemical treatment (Mirasol technology - Terumo BCT®), in order to add more transfusion security to the procedure. Finally, it will be transfused to CoViD-19 patients hospitalized in any of the participating clinics. There are currently no reported significant adverse events associated with this therapy. Have been published two serial cases reports,more evidence is necessary to standardize the treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old

• Confirmed laboratory diagnosis for qRT-PCR to SARS-CoV-2

• Meet any of the following medical criteria (Defined by WHO): Be currently hospitalized with: Pneumonia, Severe pneumonia, Acute Respiratory Distress Syndrome (moderate or severe), Sepsis or Septic shock

• The patient, or his representative, must sign an informed consent

Exclusion Criteria:

• Participate in another clinical trial for CoViD- 19

• History of acute allergic transfusion reactions due to transfusion of blood or other components, especially plasma components (fresh frozen plasma, cryoprecipitate and platelets),

• History of allergic reaction due to IgA deficiency

• Allergic reaction to sodium citrate or riboflavin (vitamin B2)

• History of immunosuppression

Related Conditions & MeSH terms

• Coronavirus Infections
• Infections, Coronavirus

Intervention

Drug:
• Inactivated convalescent plasma
Day 0: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma, Start of support treatment selected by medical staff according to each institutional protocol Day 1: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma
• Support treatment
Day 0: Start of support treatment selected by medical staff according to each each institutional protocol

Locations

Country	Name	City	State
Colombia	Clínica Corpas	Bogotá
Colombia	National Blood Center Foundation, Hemolife/Fundación Banco Nacional de Sangre Hemolife	Bogotá	Cundinamarca
Colombia	Clinica Nuestra	Cali	Valle
Colombia	E.S.E Hospital San Rafael Facatativa	Facatativa
Colombia	Clínica Antioquía	Medellín	Antioquía
Colombia	Clínica Sagrado Corazón	Medellín	Antioquía
Colombia	IPS Universitaria	Medellín	Antioquía
Colombia	Universidad de Antioquía	Medellín	Antioquía
Colombia	Clínica Rosales	Pereira	Risaralda
Colombia	Clínica la Estancia	Popayán

Sponsors (1)

Lead Sponsor	Collaborator
National Blood Center Foundation, Hemolife

Country where clinical trial is conducted

Colombia, 

References & 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. — View Citation

Epstein J, Burnouf T. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Vox Sang. 2020 Apr 22. doi: 10.1111/vox.12939. [Epub ahead of print] — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events	Occurrence of adverse events during inactivated convalescent plasma transfusion, classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0	Up to 28 days
Primary	Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment	To assess the efficacy in reducing mortality in CoViD-19 patients treated with inactivated convalescent plasma together with the support treatment selected by the respective hospital	Over a period of 28 days
Secondary	Clinical evolution	Number of Participants with resolution of fever (<38ºC temperature)	Over a period of 28 days
Secondary	Clinical evolution by seven-parameter ordinal scale	The clinical improvement will be established with a two-point improvement within this seven categories (recommended by World Organization Health-WHO): 1) Not hospitalized, with resumption of normal activities 2) Not hospitalized, but unable to resume normal activities 3) Hospitalized that does not require supplemental oxygen 4) Hospitalized requiring supplemental oxygen 5) Hospitalized requiring high-flow nasal oxygen therapy, non-invasive mechanical ventilation, or both 6) Hospitalized requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both 7) death	3, 7, 14 and 28 days
Secondary	Multi-organ failure progression	Evolution by SOFA (Sequential Organ Failure Assessment), The range is between 0 and 24 points, with the highest scores being indicators of a more serious illness	3, 7, 14 and 28 days
Secondary	Change in hemoglobin concentration	Compare the change in hemoglobin concentration at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Change in blood cell count	Compare the change in blood cell count at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Change in serum creatinine level	Compare the change in Serum creatinine concentration at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Change in aspartate aminotransferase level	Compare the change in aspartate aminotransferase level at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Change in alanin aminotransferase level	Compare the change in Alanine aminotransferase levels at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Change in bilirubin level	Compare the change in bilirubin levels at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Change in lactate dehydrogenase level	Compare the change in lactate dehydrogenase levels at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Change in creatine kinase level	Compare the change in creatine kinase levels at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Change in creatine kinase MB level	Compare the change in creatine kinase MB levels at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Change in C reactive protein concentration	Compare the change in C reactive protein concentration at 3, 7, 14 and 28 days after treatment, in mg/L	3, 7, 14 and 28 days
Secondary	Change in D Dimer concentration	Compare the change in D Dimer concentration at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Change in Procalcitonin concentration	Compare the change in procalcitonin concentration at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Change in IL6 level	Compare the change in IL6 level at 3, 7, 14 and 28 days after treatment	3, 7, 14 and 28 days
Secondary	Radiography imaging	Resolution of chest radiography imaging findings (example, bilateral, peripheral and basal predominant ground-glass opacity, consolidation, or both)	Over a period of 60 days
Secondary	Tomography imaging	Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)	Over a period of 60 days
Secondary	Assessment of oxygenation	Arterial oxygen partial pressure (PaO2) in mmHg / Inspired fraction of oxygen (FIO2) ratio	3, 7, 14 and 28 days
Secondary	Viral Load	Viral Load Quantification	0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first
Secondary	Antibody titer	Neutralizing antibody anti SARS-CoV-2 titer evolution	Day 0, Day 3 and Day 7
Secondary	Oxygen-free days through Day 60	Number of days without use of Oxygen	Until hospital discharge or a maximum of 60 days whichever comes first
Secondary	Mechanical ventilation-free days through Day 28	Number of days without use of mechanical ventilation	Until hospital discharge or a maximum of 28 days whichever comes first
Secondary	Intensive Care Unit (ICU)-free days through Day 28	Time outside of ICU, in days	Until hospital discharge or a maximum of 28 days whichever comes first
Secondary	Hospital-free days through Day 60	Time outside of the hospital, in days	Until hospital discharge or a maximum of 60 days whichever comes first

External Links

•   Regulatory considerations for the use of convalescent plasma to CoViD-19 emergency