Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19
1 other identifier
interventional
60
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2020
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedStudy Start
First participant enrolled
June 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJune 2, 2020
May 1, 2020
5 months
May 6, 2020
May 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (25)
Clinical evolution
Over a period of 28 days
Clinical evolution by seven-parameter ordinal scale
3, 7, 14 and 28 days
Multi-organ failure progression
3, 7, 14 and 28 days
Change in hemoglobin concentration
3, 7, 14 and 28 days
Change in blood cell count
3, 7, 14 and 28 days
- +20 more secondary outcomes
Other Outcomes (1)
Incidence of adverse events
Up to 28 days
Study Arms (2)
Convalescent plasma+Support treatment selected by the hospital
EXPERIMENTALParticipants 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
ACTIVE COMPARATORThe 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Clínica Antioquía
Medellín, Antioquía, 0500, Colombia
Clínica Sagrado Corazón
Medellín, Antioquía, 0500, Colombia
IPS Universitaria
Medellín, Antioquía, 0500, Colombia
Universidad de Antioquía
Medellín, Antioquía, 0500, Colombia
National Blood Center Foundation, Hemolife/Fundación Banco Nacional de Sangre Hemolife
Bogotá, Cundinamarca, 1101, Colombia
Clínica Rosales
Pereira, Risaralda Department, Colombia
Clinica Nuestra
Cali, Valle del Cauca Department, Colombia
Clínica Corpas
Bogotá, Colombia
E.S.E Hospital San Rafael Facatativa
Facatativá, Colombia
Clínica la Estancia
Popayán, Colombia
Related Publications (3)
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.
PMID: 32319102BACKGROUNDShen 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.
PMID: 32219428BACKGROUNDCasadevall 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.
PMID: 32167489BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrés F Zuluaga, MD, MSc, MeH
Universidad de Antioquia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2020
First Posted
May 12, 2020
Study Start
June 20, 2020
Primary Completion
November 30, 2020
Study Completion
December 30, 2020
Last Updated
June 2, 2020
Record last verified: 2020-05