Skip to main content
OpenTrials
Completed

NCT Number: NCT04447131

Effect of COVID-19 on Platelet Aggregation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto de infectologia Emílio Ribas, São Paulo, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

venipuncture in peripheral vein

Other

single vacuum venipuncture in peripheral vein

Primary outcomes

  1. Platelet aggregation analyzed by Multiplate-ADP

    Time frame: at inclusion

    Compare platelet aggregation analyzed by Multiplate-ADP in hospitalized patients diagnosed with COVID-19 versus healthy controls.

Secondary outcomes

  1. Platelet aggregation by Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus healthy controls.

    Time frame: at inclusion

    Compare platelet aggregation by Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus healthy controls.

  2. Reticulated platelet fraction in patients hospitalized for COVID-19 versus healthy controls.

    Time frame: at inclusion

    Compare the levels of the reticulated platelet fraction in patients hospitalized for COVID-19 versus healthy controls.

  3. Platelet aggregation for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19.

    Time frame: 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.

  4. Reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for respiratory symptoms but negative for COVID-19 research.

    Time frame: 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.

  5. Platelet aggregation in patients hospitalized for COVID-19 versus patients hospitalized for Influenza.

    Time frame: at inclusion

    Compare platelet aggregation by Multiplate-ADP, Multiplate-ASPI and Multiplate-TRAP in patients hospitalized for COVID-19 versus patients hospitalized for Influenza.

  6. Reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for Influenza.

    Time frame: at inclusion

    Compare the levels of the reticulated platelet fraction in patients hospitalized for COVID-19 versus patients hospitalized for Influenza.

  7. Platelete aggreggation versus composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization

    Time frame: 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

  8. Reticulated platelet fraction versus composite outcome of death from any cause, thrombotic events, need for ICU, need for intubation during hospitalization

    Time frame: 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;

  9. Platelet aggregation versus time (days) of total hospitalization and in the ICU

    Time frame: 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;

  10. Reticulated platelet fraction versus time (days) of total hospitalization and in the ICU

    Time frame: at inclusion

    Correlate the levels of the reticulated platelet fraction with the time (days) of total hospitalization and in the ICU;

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2023
First posted
Jun 25, 2020
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.