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COVID-19NCT04447131

Effect of COVID-19 on Platelet Aggregation

An observational study of COVID-19 and SARS-CoV-2, run by University of Sao Paulo at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19, SARS-CoV-2
What is being tested?
venipuncture in peripheral vein
How many people
120 participants
Where
2 sitesBrazil
Study dates
29 Apr 2020to 27 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo

    São Paulo, 05403-900

  • Instituto de infectologia Emílio Ribas

    São Paulo

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Conditions
COVID-19, SARS-CoV-2
Being tested
venipuncture in peripheral vein
Keywords
Platelet aggreggation, COVID-19, SARS-CoV-2, Multiplate
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • venipuncture in peripheral veinOther

    single vacuum venipuncture in peripheral vein

Study groups in NCT04447131
Study groupRoleWhat they receive
COVID-19Confirmation of the diagnosis of COVID-19 by laboratory method (RT-PCR and / or positive serology for SARS-CoV-2 - COVID group).
Receives: Other: venipuncture in peripheral vein
Healthy IndividualsAsymptomatic and with negative SARS-CoV-2 serology
Receives: Other: venipuncture in peripheral vein
Respiratory symptoms but negative for COVID-19Negative for SARS-CoV-2. But with respiratory symptoms
Receives: Other: venipuncture in peripheral vein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Platelet aggregation analyzed by Multiplate-ADP

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

    Measured: at inclusion

Secondary outcomes (10)

  1. 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.

    Measured: at inclusion

  2. 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.

    Measured: at inclusion

  3. 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.

    Measured: at inclusion,

  4. 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.

    Measured: at inclusion

  5. 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.

    Measured: at inclusion

  6. 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.

    Measured: at inclusion

  7. 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

    Measured: at inclusion

  8. 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;

    Measured: at inclusion

  9. 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;

    Measured: at inclusion

  10. 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;

    Measured: at inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2020
  2. Study start29 Apr 2020
  3. Primary completion30 Jun 2020
  4. Study completion27 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04447131
Sponsor's protocol ID
SDC 5089/20/118
Status last verified
Apr 2025
First submitted
17 Jun 2020
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29365305

  • 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.

    PubMed 29761104

  • 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.

    PubMed 18537597

  • 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.

    PubMed 20113977

  • 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.

    PubMed 22383669

  • 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.

    PubMed 25664391

  • 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.

    PubMed 32171076

  • 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.

    PubMed 32139904

  • 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.

    PubMed 32031570

  • 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.

    PubMed 10075613

  • 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.

    PubMed 22809844

  • Bertolin AJ, Dalcoquio TF, Salsoso R, de M Furtado RH, Kalil-Filho R, Hajjar LA, Siciliano RF, Kallas EG, Baracioli LM, Lima FG, Giraldez RR, Cavalheiro-Filho C, Vieira A, Strunz CMC, Giugliano RP, Tantry US, Gurbel PA, Nicolau JC. Platelet Reactivity and Coagulation Markers in Patients with COVID-19. Adv Ther. 2021 Jul;38(7):3911-3923. doi: 10.1007/s12325-021-01803-w. Epub 2021 Jun 4.

    PubMed 34086266

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and SARS-CoV-2, run by University of Sao Paulo at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Platelet aggregation analyzed by Multiplate-ADP (time frame: at inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04447131, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.

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Effect of COVID-19 on Platelet Aggregation | AzTrials