Effect of COVID-19 on Platelet Aggregation
- Conditions
- COVID-19SARS-CoV-2
- Interventions
- Other: venipuncture in peripheral vein
- Registration Number
- NCT04447131
- Lead Sponsor
- University of Sao Paulo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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)
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 venipuncture in peripheral vein Confirmation of the diagnosis of COVID-19 by laboratory method (RT-PCR and / or positive serology for SARS-CoV-2 - COVID group). Healthy Individuals venipuncture in peripheral vein Asymptomatic and with negative SARS-CoV-2 serology Respiratory symptoms but negative for COVID-19 venipuncture in peripheral vein Negative for SARS-CoV-2. But with respiratory symptoms
- Primary Outcome Measures
Name Time Method Platelet aggregation analyzed by Multiplate-ADP at inclusion Compare platelet aggregation analyzed by Multiplate-ADP in hospitalized patients diagnosed with COVID-19 versus healthy controls.
- Secondary Outcome Measures
Name Time Method Platelet aggregation by Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus healthy controls. at inclusion Compare platelet aggregation by Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus healthy controls.
Platelet aggregation in patients hospitalized for COVID-19 versus patients hospitalized for Influenza. at inclusion Compare platelet aggregation by Multiplate-ADP, Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus patients hospitalized for Influenza.
Platelet aggregation versus time (days) of total hospitalization and in the ICU at inclusion Compare the levels of platelet aggregation (by Multiplate ADP, ASPI and TRAP) with the time (days) of total hospitalization and in the ICU;
Reticulated platelet fraction in patients hospitalized for COVID-19 versus healthy controls. at inclusion Compare the levels of the reticulated platelet fraction in patients hospitalized for COVID-19 versus healthy controls.
Reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for Influenza. at inclusion Compare the levels of the reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for Influenza.
Platelete aggreggation versus composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization at inclusion Compare the levels of platelet aggregation (by Multiplate ADP, ASPI and TRAP) in patients with or without the composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization Compare the levels of platelet aggregation (by Multiplate ADP, ASPI and TRAP) in patients with or without the composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization
Reticulated platelet fraction versus composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization at inclusion Compare the levels of the reticulated platelet fraction in patients with or without the composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization;
Platelet aggregation for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19. at inclusion, Compare platelet aggregation by Multiplate-ADPMultiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19.
Reticulated platelet fraction versus time (days) of total hospitalization and in the ICU at inclusion Correlate the levels of the reticulated platelet fraction with the time (days) of total hospitalization and in the ICU;
Reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19 research. at inclusion Compare the levels of the reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19.
Trial Locations
- Locations (2)
Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
🇧🇷Sao Paulo, Brazil
Instituto de infectologia Emílio Ribas
🇧🇷São Paulo, Brazil