Effect of COVID-19 on Platelet Aggregation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID-19 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
single vacuum venipuncture in peripheral vein
|
| Healthy Individuals Asymptomatic and with negative SARS-CoV-2 serology |
Other: venipuncture in peripheral vein
single vacuum venipuncture in peripheral vein
|
| Respiratory symptoms but negative for COVID-19 Negative for SARS-CoV-2. But with respiratory symptoms |
Other: venipuncture in peripheral vein
single vacuum venipuncture in peripheral vein
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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 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.
- 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.
- 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 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 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;
Eligibility Criteria
Criteria
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.
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Control group: healthy volunteers, defined as having no history (confirmed or suspected) of COVID-19 or chronic diseases (except hypertension, obesity, dyslipidemia)
Exclusion Criteria:
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Known platelet dysfunction or platelet count <100,000 / µL or> 450,000 / µL;
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Terminal illness;
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Known liver disease or clotting disorder;
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Hematocrit less than 34% or greater than 55%;
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Previous use of antiplatelet agents and / or anticoagulants (except acetylsalicylic acid and prophylactic heparin);
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Patients on invasive mechanical ventilation or receiving high oxygen flow.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo | Sao Paulo | Brazil | 05403-900 | |
| 2 | Instituto de infectologia Emílio Ribas | São Paulo | Brazil |
Sponsors and Collaborators
- University of Sao Paulo
- Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- Hottz ED, Bozza FA, Bozza PT. Platelets in Immune Response to Virus and Immunopathology of Viral Infections. Front Med (Lausanne). 2018 Apr 30;5:121. doi: 10.3389/fmed.2018.00121. eCollection 2018. Review.
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- Rondina MT, Brewster B, Grissom CK, Zimmerman GA, Kastendieck DH, Harris ES, Weyrich AS. In vivo platelet activation in critically ill patients with primary 2009 influenza A(H1N1). Chest. 2012 Jun;141(6):1490-1495. doi: 10.1378/chest.11-2860. Epub 2012 Mar 1.
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- Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113.
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- SDC 5089/20/118