Effect of SARS-CoV-2 Infection on Platelet Aggregation and Other Coagulation Parameters
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Platelet aggregation analyzed by Multiplate-ADP
Study Overview
Brief Summary
This is a mechanistic, observational, prospective, case and control study, to compare platelet aggregation, analyzed by Multiplate-ADP, in hospitalized patients diagnosed with COVID-19 versus healthy controls. Thus will be included 60 patients who present with respiratory symptoms within 72 hours of hospitalization and confirmation of the diagnosis of COVID-19 by laboratory method (RT -PCR and / or positive serology for SARS-CoV-2 - COVID group); this group will be compared to 60 healthy individuals (asymptomatic and with negative SARS-CoV-2 serology), matched by sex and age to the previous group.
Detailed Description
There is strong evidence that SARS-CoV-2 infection is associated with atherothrombotic phenomena. However, platelet activity in COVID-19 has not yet been studied.
Thus, the main objective of this project is to evaluate platelet aggregation by the Multiplate-ADP method in hospitalized patients diagnosed with COVID-19, in comparison with the platelet aggregation evaluated by the same method in healthy controls.
Secondary objectives include the assessment of parameters related to coagulation, inflammation, and clinical outcome variables.
This is a mechanistic, observational, prospective, case and control study, which will include 60 patients who present with respiratory symptoms within 72 hours of hospitalization and confirmation of the diagnosis of COVID-19 by laboratory method (RT -PCR and / or positive serology for SARS-CoV-2 - COVID group); this group will be compared to 60 healthy individuals (asymptomatic and with negative SARS-CoV-2 serology), matched by sex and age to the previous group.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Agreement to sign the Free and Informed Consent Form (ICF).
- •Case group: patients with up to 72 hours of hospitalization for respiratory symptoms.
- •Control group: healthy volunteers, defined as having no history (confirmed or suspected) of COVID-19 or chronic diseases (except hypertension, obesity, dyslipidemia)
Exclusion Criteria
- •Known platelet dysfunction or platelet count <100,000 / µL or> 450,000 / µL;
- •Terminal illness;
- •Known liver disease or clotting disorder;
- •Hematocrit less than 34% or greater than 55%;
- •Previous use of antiplatelet agents and / or anticoagulants (except acetylsalicylic acid and prophylactic heparin);
- •Patients on invasive mechanical ventilation or receiving high oxygen flow.
Outcomes
Primary Outcomes
Platelet aggregation analyzed by Multiplate-ADP
Time Frame: at inclusion
Compare platelet aggregation analyzed by Multiplate-ADP in hospitalized patients diagnosed with COVID-19 versus healthy controls.
Secondary Outcomes
- Platelet aggregation by Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus healthy controls.(at inclusion)
- Platelet aggregation in patients hospitalized for COVID-19 versus patients hospitalized for Influenza.(at inclusion)
- Platelet aggregation versus time (days) of total hospitalization and in the ICU(at inclusion)
- Reticulated platelet fraction in patients hospitalized for COVID-19 versus healthy controls.(at inclusion)
- Reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for Influenza.(at inclusion)
- Platelete aggreggation versus composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization(at inclusion)
- Reticulated platelet fraction versus composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization(at inclusion)
- Platelet aggregation for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19.(at inclusion,)
- Reticulated platelet fraction versus time (days) of total hospitalization and in the ICU(at inclusion)
- Reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19 research.(at inclusion)
Investigators
Jose Carlos Nicolau
Director of Coronary Care Unit
University of Sao Paulo