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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 | Confirmation of the diagnosis of COVID-19 by laboratory method (RT-PCR and / or positive serology for SARS-CoV-2 - COVID group). |
| |
| Healthy Individuals | Asymptomatic and with negative SARS-CoV-2 serology |
| |
| Respiratory symptoms but negative for COVID-19 | Negative for SARS-CoV-2. But with respiratory symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venipuncture in peripheral vein | Other | single vacuum venipuncture in peripheral vein |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with up to 72 hours of hospitalization for respiratory symptoms, tested with RT- PCR for respiratory viruses, will be evaluated for inclusion. Patients with diagnostic criteria for COVID-19 will be considered a case group (COVID-19 group) and will be compared to two other groups: patients hospitalized for respiratory symptoms with a negative test for SARS-CoV-2, and healthy control group.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo | São Paulo | 05403-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29365305 | Background | Kwong JC, Schwartz KL, Campitelli MA, Chung H, Crowcroft NS, Karnauchow T, Katz K, Ko DT, McGeer AJ, McNally D, Richardson DC, Rosella LC, Simor A, Smieja M, Zahariadis G, Gubbay JB. Acute Myocardial Infarction after Laboratory-Confirmed Influenza Infection. N Engl J Med. 2018 Jan 25;378(4):345-353. doi: 10.1056/NEJMoa1702090. | |
| 29761104 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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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 |
| Instituto de infectologia Emílio Ribas | São Paulo | Brazil |
| 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. |
| 18537597 | Background | McNicol A, Israels SJ. Beyond hemostasis: the role of platelets in inflammation, malignancy and infection. Cardiovasc Hematol Disord Drug Targets. 2008 Jun;8(2):99-117. doi: 10.2174/187152908784533739. |
| 20113977 | Background | Corrales-Medina VF, Madjid M, Musher DM. Role of acute infection in triggering acute coronary syndromes. Lancet Infect Dis. 2010 Feb;10(2):83-92. doi: 10.1016/S1473-3099(09)70331-7. |
| 22383669 | Background | 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. |
| 25664391 | Background | Le VB, Schneider JG, Boergeling Y, Berri F, Ducatez M, Guerin JL, Adrian I, Errazuriz-Cerda E, Frasquilho S, Antunes L, Lina B, Bordet JC, Jandrot-Perrus M, Ludwig S, Riteau B. Platelet activation and aggregation promote lung inflammation and influenza virus pathogenesis. Am J Respir Crit Care Med. 2015 Apr 1;191(7):804-19. doi: 10.1164/rccm.201406-1031OC. |
| 32171076 | Background | Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. |
| 32139904 | Background | Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5. |
| 32031570 | Background | 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. |
| 10075613 | Background | Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002. |
| 22809844 | Background | Rubak P, Villadsen K, Hvas AM. Reference intervals for platelet aggregation assessed by multiple electrode platelet aggregometry. Thromb Res. 2012 Sep;130(3):420-3. doi: 10.1016/j.thromres.2012.06.017. Epub 2012 Jul 17. |
| 34086266 | Derived | Bertolin AJ, Dalcoquio TF, Salsoso R, de M Furtado RH, Kalil-Filho R, Hajjar LA, Siciliano RF, Kallas EG, Baracioli LM, Lima FG, Giraldez RR, Cavalheiro-Filho C, Vieira A, Strunz CMC, Giugliano RP, Tantry US, Gurbel PA, Nicolau JC. Platelet Reactivity and Coagulation Markers in Patients with COVID-19. Adv Ther. 2021 Jul;38(7):3911-3923. doi: 10.1007/s12325-021-01803-w. Epub 2021 Jun 4. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |