Clinical trial NCT04447131: Effect of COVID-19 on Platelet Aggregation
Official title: Effect of SARS-CoV-2 Infection on Platelet Aggregation and Other Coagulation Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV-2
Keywords: Platelet aggreggation
COVID-19
SARS-CoV-2
Multiplate
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2020-06-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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.
* 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.

Primary outcomes:
measure: Platelet aggregation analyzed by Multiplate-ADP
timeFrame: at inclusion
Secondary outcomes:
measure: Platelet aggregation by Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus healthy controls.
timeFrame: at inclusion
measure: Reticulated platelet fraction in patients hospitalized for COVID-19 versus healthy controls.
timeFrame: at inclusion
measure: Platelet aggregation for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19.
timeFrame: at inclusion,
measure: Reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19 research.
timeFrame: at inclusion
measure: Platelet aggregation in patients hospitalized for COVID-19 versus patients hospitalized for Influenza.
timeFrame: at inclusion
measure: Reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for Influenza.
timeFrame: at inclusion
measure: Platelete aggreggation versus composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization
timeFrame: at inclusion
measure: Reticulated platelet fraction versus composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization
timeFrame: at inclusion
measure: Platelet aggregation versus time (days) of total hospitalization and in the ICU
timeFrame: at inclusion
measure: Reticulated platelet fraction versus time (days) of total hospitalization and in the ICU
timeFrame: at inclusion
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
city: São Paulo
country: Brazil
facility: Instituto de infectologia Emílio Ribas
Study officials:
References:
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