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Effect of COVID-19 on Platelet Aggregation

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ClinicalTrials.gov Identifier: NCT04447131
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Jose Carlos Nicolau, University of Sao Paulo

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 50 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 50 healthy individuals (asymptomatic and with negative SARS-CoV-2 serology), matched by sex and age to the previous group.

Condition or disease Intervention/treatment
COVID-19 SARS-CoV-2 Other: venipuncture in peripheral vein

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 50 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 50 healthy individuals (asymptomatic and with negative SARS-CoV-2 serology), matched by sex and age to the previous group.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of SARS-CoV-2 Infection on Platelet Aggregation and Other Coagulation Parameters
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : December 30, 2020

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

Influenza
Positive for influenza vírus. Negative for SARS-CoV-2.
Other: venipuncture in peripheral vein
single vacuum venipuncture in peripheral vein

Respiratory symptoms but negative for influenza or COVID-19
Negative for influenza vírus. Negative for SARS-CoV-2. But with respiratory symptoms
Other: venipuncture in peripheral vein
single vacuum venipuncture in peripheral vein




Primary Outcome Measures :
  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 Outcome Measures :
  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 Influenza and COVID-19 research. [ 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 respiratory symptoms but negative for Influenza and COVID-19 research.

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

  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;

  11. Platelet aggregation versus WHO ordinal scale of outcomes for COVID-19 [ Time Frame: within 28 (± 3 days) of inclusion ]
    Correlate the levels of platelet aggregation (by Multiplate ADP, ASPI and TRAP) and the fraction of reticulated platelets with maximum score obtained on the WHO ordinal scale of outcomes for COVID-19 within 28 (± 3 days) of inclusion:



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 three other groups: Influenza infection (Influenza group), patients hospitalized for respiratory symptoms with a negative test for SARS-CoV-2 and Influenza , and healthy control group.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04447131


Locations
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Brazil
Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 05403-900
Contact: José Carlos Nicolau    551126615058    josecarlosnicolau@gmail.com   
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Publications:

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Responsible Party: Jose Carlos Nicolau, Director of Coronary Care Unit, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04447131    
Other Study ID Numbers: SDC 5089/20/118
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Carlos Nicolau, University of Sao Paulo:
Platelet aggreggation
COVID-19
SARS-CoV-2
Multiplate