Effect of COVID-19 on Platelet Aggregation

University of Sao Paulo

Status

Completed

Conditions

COVID-19

SARS-CoV-2

Treatments

Other: venipuncture in peripheral vein

Study type

Observational

Funder types

Other

Identifiers

NCT04447131

SDC 5089/20/118

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.