Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19
- Conditions
- Infections, Coronavirus
- Interventions
- Drug: Inactivated convalescent plasmaDrug: Support treatment
- Registration Number
- NCT04385186
- Lead Sponsor
- National Blood Center Foundation, Hemolife
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Convalescent plasma+Support treatment selected by the hospital Inactivated convalescent plasma Participants will receive two doses of ABO - Rh compatible inactivated convalescent plasma, each one of 200 mililiters (mL), with a 24-hour interval via transfusion, for a final volume of 400 mL, meanwhile they continue to receive the supportive treatment chosen by the hospitals, according to each institutional protocol. Convalescent plasma+Support treatment selected by the hospital Support treatment Participants will receive two doses of ABO - Rh compatible inactivated convalescent plasma, each one of 200 mililiters (mL), with a 24-hour interval via transfusion, for a final volume of 400 mL, meanwhile they continue to receive the supportive treatment chosen by the hospitals, according to each institutional protocol. Support treatment selected by the hospital Support treatment The best support treatment selected by the hospital, according to each institutional protocol. Due to the ongoing development of knowledge of pathophysiology and scientific evidence of the available alternatives, it will be selected at the time of treatment.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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)
Antibody titer Day 0, Day 3 and Day 7 Neutralizing antibody anti SARS-CoV-2 titer evolution
Clinical evolution Over a period of 28 days Number of Participants with resolution of fever (\<38ºC temperature)
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
Viral Load 0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first Viral Load Quantification
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 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 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 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
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
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 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 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
Assessment of oxygenation 3, 7, 14 and 28 days Arterial oxygen partial pressure (PaO2) in mmHg / Inspired fraction of oxygen (FIO2) ratio
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
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 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 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
Tomography imaging Over a period of 60 days Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)
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
Trial Locations
- Locations (10)
Clínica Antioquía
🇨🇴Medellín, Antioquía, Colombia
Clínica Sagrado Corazón
🇨🇴Medellín, Antioquía, Colombia
IPS Universitaria
🇨🇴Medellín, Antioquía, Colombia
Universidad de Antioquía
🇨🇴Medellín, Antioquía, Colombia
National Blood Center Foundation, Hemolife/Fundación Banco Nacional de Sangre Hemolife
🇨🇴Bogotá, Cundinamarca, Colombia
Clínica Corpas
🇨🇴Bogotá, Colombia
Clínica Rosales
🇨🇴Pereira, Risaralda, Colombia
Clinica Nuestra
🇨🇴Cali, Valle, Colombia
Clínica la Estancia
🇨🇴Popayán, Colombia
E.S.E Hospital San Rafael Facatativa
🇨🇴Facatativa, Colombia