Effect of COVID-19 on Platelet Aggregation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of SARS-CoV-2 Infection on Platelet Aggregation and Other Coagulation Parameters

Conditions
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COVID-19, SARS-CoV-2

Intervention / Treatment
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* Other: venipuncture in peripheral vein


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19<br>Confirmation of the diagnosis of COVID-19 by laboratory method (RT-PCR and / or positive serology for SARS-CoV-2 - COVID group). | Other: venipuncture in peripheral vein<br>* single vacuum venipuncture in peripheral vein<br>|
| Healthy Individuals<br>Asymptomatic and with negative SARS-CoV-2 serology | Other: venipuncture in peripheral vein<br>* single vacuum venipuncture in peripheral vein<br>|
| Respiratory symptoms but negative for COVID-19<br>Negative for SARS-CoV-2. But with respiratory symptoms | Other: venipuncture in peripheral vein<br>* single vacuum venipuncture in peripheral vein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet aggregation analyzed by Multiplate-ADP | Compare platelet aggregation analyzed by Multiplate-ADP in hospitalized patients diagnosed with COVID-19 versus healthy controls. | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet aggregation by Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus healthy controls. | Compare platelet aggregation by Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus healthy controls. | at inclusion | 
| Reticulated platelet fraction in patients hospitalized for COVID-19 versus healthy controls. | Compare the levels of the reticulated platelet fraction in patients hospitalized for COVID-19 versus healthy controls. | at inclusion | 
| Platelet aggregation for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19. | 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. | at inclusion, | 
| Reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19 research. | 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. | at inclusion | 
| Platelet aggregation in patients hospitalized for COVID-19 versus patients hospitalized for Influenza. | Compare platelet aggregation by Multiplate-ADP, Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus patients hospitalized for Influenza. | at inclusion | 
| Reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for Influenza. | Compare the levels of the 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 | 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 | at inclusion | 
| Reticulated platelet fraction versus composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization | 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; | at inclusion | 
| Platelet aggregation versus time (days) of total hospitalization and in the ICU | Compare the levels of platelet aggregation (by Multiplate ADP, ASPI and TRAP) with the time (days) of total hospitalization and in the ICU; | at inclusion | 
| Reticulated platelet fraction versus time (days) of total hospitalization and in the ICU | Correlate the levels of the reticulated platelet fraction with the time (days) of total hospitalization and in the ICU; | at inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet aggreggation, COVID-19, SARS-CoV-2, Multiplate