Infections, Coronavirus
Conditions
Keywords
CoViD-19, Pathogen inactivation, Apheresis, Convalescent plasma
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.
Interventions
DRUGInactivated 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
Day 0: Start of support treatment selected by medical staff according to each each institutional protocol
Sponsors
National Blood Center Foundation, Hemolife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
MULTICENTER, CONTROLLED, RANDOMIZED, SIMPLE BLIND, CLINICAL TRIAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment | Over a period of 28 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical evolution | Over a period of 28 days | Number of Participants with resolution of fever (\<38ºC temperature) |
| Clinical evolution by seven-parameter ordinal scale | 3, 7, 14 and 28 days | 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 |
| Multi-organ failure progression | 3, 7, 14 and 28 days | 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 |
| Change in hemoglobin concentration | 3, 7, 14 and 28 days | Compare the change in hemoglobin concentration at 3, 7, 14 and 28 days after treatment |
| Change in blood cell count | 3, 7, 14 and 28 days | Compare the change in blood cell count at 3, 7, 14 and 28 days after treatment |
| Change in serum creatinine level | 3, 7, 14 and 28 days | Compare the change in Serum creatinine concentration at 3, 7, 14 and 28 days after treatment |
| Change in aspartate aminotransferase level | 3, 7, 14 and 28 days | Compare the change in aspartate aminotransferase level at 3, 7, 14 and 28 days after treatment |
| Change in alanin aminotransferase level | 3, 7, 14 and 28 days | Compare the change in Alanine aminotransferase levels at 3, 7, 14 and 28 days after treatment |
| Change in bilirubin level | 3, 7, 14 and 28 days | Compare the change in bilirubin levels at 3, 7, 14 and 28 days after treatment |
| Change in lactate dehydrogenase level | 3, 7, 14 and 28 days | Compare the change in lactate dehydrogenase levels at 3, 7, 14 and 28 days after treatment |
| Change in creatine kinase level | 3, 7, 14 and 28 days | Compare the change in creatine kinase levels at 3, 7, 14 and 28 days after treatment |
| Change in creatine kinase MB level | 3, 7, 14 and 28 days | Compare the change in creatine kinase MB levels at 3, 7, 14 and 28 days after treatment |
| Change in D Dimer concentration | 3, 7, 14 and 28 days | Compare the change in D Dimer concentration at 3, 7, 14 and 28 days after treatment |
| Change in Procalcitonin concentration | 3, 7, 14 and 28 days | Compare the change in procalcitonin concentration at 3, 7, 14 and 28 days after treatment |
| Change in IL6 level | 3, 7, 14 and 28 days | Compare the change in IL6 level at 3, 7, 14 and 28 days after treatment |
| Radiography imaging | Over a period of 60 days | Resolution of chest radiography imaging findings (example, bilateral, peripheral and basal predominant ground-glass opacity, consolidation, or both) |
| Tomography imaging | Over a period of 60 days | Resolution of tomography imaging (example, patches located in the subpleural regions of the lung) |
| Assessment of oxygenation | 3, 7, 14 and 28 days | Arterial oxygen partial pressure (PaO2) in mmHg / Inspired fraction of oxygen (FIO2) ratio |
| Viral Load | 0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first | Viral Load Quantification |
| Antibody titer | Day 0, Day 3 and Day 7 | Neutralizing antibody anti SARS-CoV-2 titer evolution |
| Oxygen-free days through Day 60 | Until hospital discharge or a maximum of 60 days whichever comes first | Number of days without use of Oxygen |
| Mechanical ventilation-free days through Day 28 | Until hospital discharge or a maximum of 28 days whichever comes first | Number of days without use of mechanical ventilation |
| Intensive Care Unit (ICU)-free days through Day 28 | Until hospital discharge or a maximum of 28 days whichever comes first | Time outside of ICU, in days |
| Hospital-free days through Day 60 | Until hospital discharge or a maximum of 60 days whichever comes first | Time outside of the hospital, in days |
| Change in C reactive protein concentration | 3, 7, 14 and 28 days | Compare the change in C reactive protein concentration at 3, 7, 14 and 28 days after treatment, in mg/L |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Up to 28 days | 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 |
Countries
Colombia
Contacts
Primary ContactAndrés F Zuluaga, MD, MSc, MeH
Backup ContactAna L Muñoz, MSc, PhD
Outcome results
None listed