Effect of COVID-19 on Platelet Aggregation

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447131
• Other study ID #: SDC 5089/20/118
• Status: Completed
• Start date: April 29, 2020
• Est. completion date: November 27, 2023

Study information

• Verified date: November 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 27, 2023
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Other:
• venipuncture in peripheral vein
single vacuum venipuncture in peripheral vein

Locations

Country	Name	City	State
Brazil	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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,
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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