Clinical trial NCT04480632: Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis
Official title: Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis / Plasmaféresis terapéutica en Pacientes Adultos críticamente Enfermos Con diagnóstico Confirmado de COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
Convalescent plasma
Intensive Care Unit
Critical illness
Lead sponsor: Fundación Cardiovascular de Colombia
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental and open-label intervention study. In this study, the application of convalescent plasma is considered as an intervention, but randomization will not be performed by investigators; one arm will be patients who received ABO compatible convalescent plasma and the comparison group will be those patients with intervention indication but without compatible ABO plasma units within the institution.
Primary purpose: TREATMENT

Brief summary: Introduction: The SARS-CoV-2 outbreak has left more than two million infected worldwide in the first four months of COVID-19 epidemic. To date, there is no specific treatment for the disease and in critically ill patients there is an additional challenge in controlling the systemic inflammatory response, which is characterized by cytokine storm, alteration in coagulation and endothelial activation in addition to infection. Strategies used in previous viral epidemics, such as convalescent plasma, are therapeutic options to rescue, especially in individuals with a critical presentation of the disease.

Aim: To establish clinical response of critically ill patients with COVID-19 who received convalescent plasma from subjects recovered from SARS-CoV-2 during their stay in Intensive Care Unit at Fundación Cardiovascular de Colombia (Hospital Internacional de Colombia).

Methodology: Quasi-experimental study (no randomization will be performed). Adult patients who meet selection criteria will receive 500 ml of ABO compatible convalescent plasma, obtained by apheresis from patients recovered from SARS-CoV-2 infection. The main outcome will be in-hospital mortality at 30 days, while indication for ventilatory support (intubation) and adverse events at thirty days will be evaluated as secondary outcomes, compared to subjects receiving usual treatment for clinical sign and symptoms given the absence of ABO compatible plasma units. A survival analysis will be performed using Kaplan-Meier method and association strength will be reported using HR and 95% CI crude and adjusted for confounding variables.

Expected results: It is expected to know the clinical and paraclinical response of patients receiving convalescent plasma in our institution, as well as to establish their probability of survival and its associated factors.


Eligibility criteria: Inclusion Criteria:

* Age range: Over 18 years old
* Patients with confirmed infection by COVID-19 (positive real-time PCR) in ICU with:
* Respiratory failure receiving ventilatory support and high parameters
* Severe pneumonia with rapid progression
* Ability to sign informed consent

Exclusion Criteria:

* Pregnant women
* Contraindication of plasma administration due to history of anaphylaxis during transfusions

Primary outcomes:
measure: In-hospital mortality
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of renal replacement therapy
timeFrame: 30 days
measure: Incidece of adverse events
timeFrame: During tranfusion until 24 hours after.
Other outcomes:
Locations:
city: Piedecuesta
country: Colombia
facility: Hospital Internacional de Colombia
state: Santander
Study officials:
affiliation: Research, development and innovation director
name: Norma Serrano, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.
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