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Effect of COVID-19 on Platelet Aggregation

U

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.

Trial design

120 participants in 3 patient groups

COVID-19
Description:
Confirmation of the diagnosis of COVID-19 by laboratory method (RT-PCR and / or positive serology for SARS-CoV-2 - COVID group).
Treatment:
Other: venipuncture in peripheral vein
Healthy Individuals
Description:
Asymptomatic and with negative SARS-CoV-2 serology
Treatment:
Other: venipuncture in peripheral vein
Respiratory symptoms but negative for COVID-19
Description:
Negative for SARS-CoV-2. But with respiratory symptoms
Treatment:
Other: venipuncture in peripheral vein

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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