Effect of COVID-19 on Platelet Aggregation

April 22, 2025 updated by: Jose Carlos Nicolau, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-900
        • Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo
      • São Paulo, Brazil
        • Instituto de Infectologia Emilio Ribas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at inclusion
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.
at inclusion
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.
at inclusion,
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.
at inclusion
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.
at inclusion
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.
at inclusion
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
at inclusion
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;
at inclusion
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;
at inclusion
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;
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

November 27, 2023

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDC 5089/20/118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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