Clinical trial NCT04385186: Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19
Official title: Inactivated Convalescent Plasma as a Therapeutic Alternative in Hospitalized Patients CoViD-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infections, Coronavirus
Keywords: CoViD-19
Pathogen inactivation
Apheresis
Convalescent plasma
Lead sponsor: National Blood Center Foundation, Hemolife
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: MULTICENTER, CONTROLLED, RANDOMIZED, SIMPLE BLIND, CLINICAL TRIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment
timeFrame: Over a period of 28 days
Secondary outcomes:
measure: Clinical evolution
timeFrame: Over a period of 28 days
measure: Clinical evolution by seven-parameter ordinal scale
timeFrame: 3, 7, 14 and 28 days
measure: Multi-organ failure progression
timeFrame: 3, 7, 14 and 28 days
measure: Change in hemoglobin concentration
timeFrame: 3, 7, 14 and 28 days
measure: Change in blood cell count
timeFrame: 3, 7, 14 and 28 days
measure: Change in serum creatinine level
timeFrame: 3, 7, 14 and 28 days
measure: Change in aspartate aminotransferase level
timeFrame: 3, 7, 14 and 28 days
measure: Change in alanin aminotransferase level
timeFrame: 3, 7, 14 and 28 days
measure: Change in bilirubin level
timeFrame: 3, 7, 14 and 28 days
measure: Change in lactate dehydrogenase level
timeFrame: 3, 7, 14 and 28 days
measure: Change in creatine kinase level
timeFrame: 3, 7, 14 and 28 days
measure: Change in creatine kinase MB level
timeFrame: 3, 7, 14 and 28 days
measure: Change in C reactive protein concentration
timeFrame: 3, 7, 14 and 28 days
measure: Change in D Dimer concentration
timeFrame: 3, 7, 14 and 28 days
measure: Change in Procalcitonin concentration
timeFrame: 3, 7, 14 and 28 days
measure: Change in IL6 level
timeFrame: 3, 7, 14 and 28 days
measure: Radiography imaging
timeFrame: Over a period of 60 days
measure: Tomography imaging
timeFrame: Over a period of 60 days
measure: Assessment of oxygenation
timeFrame: 3, 7, 14 and 28 days
measure: Viral Load
timeFrame: 0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first
measure: Antibody titer
timeFrame: Day 0, Day 3 and Day 7
measure: Oxygen-free days through Day 60
timeFrame: Until hospital discharge or a maximum of 60 days whichever comes first
measure: Mechanical ventilation-free days through Day 28
timeFrame: Until hospital discharge or a maximum of 28 days whichever comes first
measure: Intensive Care Unit (ICU)-free days through Day 28
timeFrame: Until hospital discharge or a maximum of 28 days whichever comes first
measure: Hospital-free days through Day 60
timeFrame: Until hospital discharge or a maximum of 60 days whichever comes first
Other outcomes:
measure: Incidence of adverse events
timeFrame: Up to 28 days
Locations:
city: Medellín
country: Colombia
facility: Clínica Antioquía
state: Antioquía
city: Medellín
country: Colombia
facility: Clínica Sagrado Corazón
state: Antioquía
city: Medellín
country: Colombia
facility: IPS Universitaria
state: Antioquía
city: Medellín
country: Colombia
facility: Universidad de Antioquía
state: Antioquía
city: Bogotá
country: Colombia
facility: National Blood Center Foundation, Hemolife/Fundación Banco Nacional de Sangre Hemolife
state: Cundinamarca
city: Pereira
country: Colombia
facility: Clínica Rosales
state: Risaralda
city: Cali
country: Colombia
facility: Clinica Nuestra
state: Valle
city: Bogotá
country: Colombia
facility: Clínica Corpas
city: Facatativa
country: Colombia
facility: E.S.E Hospital San Rafael Facatativa
city: Popayán
country: Colombia
facility: Clínica la Estancia
Study officials:
affiliation: Universidad de Antioquia
name: Andrés F Zuluaga, MD, MSc, MeH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epstein J, Burnouf T. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Vox Sang. 2020 Aug;115(6):485-487. doi: 10.1111/vox.12939. Epub 2020 May 14. No abstract available.
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 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
citation: 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.