Pro-thrombotic Status in Patients with SARS-Cov-2 Infection

NCT04343053 | Completed DMC

• 1 other identifier: 250320
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is ideated to prospectively investigate in patients with severe acute respiratory syndrome (SARS) due to Coronavirus 19 (SARS-Cov-2) infection and moderate-severe respiratory failure the patterns and changes in platelet reactivity, thrombotic status and endothelial function. The observed patterns and changes will be related with inflammatory status, myocardial injury and outcomes

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Outcome Measures

Primary Outcomes (3)

• on-treatment platelet reactivity

  patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli

  early stage of disease (first 96 hours)

• on-treatment platelet reactivity

  patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli

  mid stage of disease (96 hours - 14 days)

• on-treatment platelet reactivity

  patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli

  late stage of disease (>14 days)

Secondary Outcomes (16)

• apoptosis rate in human umbilical vein endothelial cells (HUVEC)

  early stage of disease (first 96 hours)

• apoptosis rate in human umbilical vein endothelial cells (HUVEC)

  mid stage of disease (96 hours - 14 days)

• Nitric oxide (NO) intracellular levels

  late stage of disease (>14 days)

• Nitric oxide (NO) intracellular levels

  early stage of disease (first 96 hours)

• Nitric oxide (NO) intracellular levels

  mid stage of disease (96 hours - 14 days)

Study Arms (1)

SARS-Cov-2 infection

OTHER

Single study group of patients with respiratory failure due to SARS-Cov-2 infection. Three blood samples will be collected at different stages of disease: early, defined as first 96 hours, mid, defined as time from 96 hours and 14 days, late. defined as \>14 days

Other: SARS-Cov-2 infection

Interventions

SARS-Cov-2 infection OTHER

blood sample withdrawal

SARS-Cov-2 infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of moderate-severe respiratory failure (PaO2/FiO2 \<200)
• Diagnosis of SARS-CoV-2 infection + one of the following
• invasive mechanical ventilation (cohort A)
• non invasive mechanical ventilation (cohort B)
• only oxygen support

You may not qualify if:

• Previous chronic use of P2Y12 inhibitors
• Need for chronic oral anti-coagulation therapy
• Know disorder of coagulation or platelet function

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Azienda Ospedaliera Universitaria di Ferrara

Ferrara, Italy

Location

Related Publications (4)

• Scaramuzzo G, Ronzoni L, Campo G, Priani P, Arena C, La Rosa R, Turrini C, Volta CA, Papi A, Spadaro S, Contoli M. Long-term dyspnea, regional ventilation distribution and peripheral lung function in COVID-19 survivors: a 1 year follow up study. BMC Pulm Med. 2022 Nov 9;22(1):408. doi: 10.1186/s12890-022-02214-5.

  PMID: 36352423 DERIVED

• Contoli M, Papi A, Tomassetti L, Rizzo P, Vieceli Dalla Sega F, Fortini F, Torsani F, Morandi L, Ronzoni L, Zucchetti O, Pavasini R, Fogagnolo A, Volta CA, Bartlett NW, Johnston SL, Spadaro S, Campo G. Blood Interferon-alpha Levels and Severity, Outcomes, and Inflammatory Profiles in Hospitalized COVID-19 Patients. Front Immunol. 2021 Mar 9;12:648004. doi: 10.3389/fimmu.2021.648004. eCollection 2021.

  PMID: 33767713 DERIVED

• Spadaro S, Fogagnolo A, Campo G, Zucchetti O, Verri M, Ottaviani I, Tunstall T, Grasso S, Scaramuzzo V, Murgolo F, Marangoni E, Vieceli Dalla Sega F, Fortini F, Pavasini R, Rizzo P, Ferrari R, Papi A, Volta CA, Contoli M. Markers of endothelial and epithelial pulmonary injury in mechanically ventilated COVID-19 ICU patients. Crit Care. 2021 Feb 19;25(1):74. doi: 10.1186/s13054-021-03499-4.

  PMID: 33608030 DERIVED

• Campo G, Contoli M, Fogagnolo A, Vieceli Dalla Sega F, Zucchetti O, Ronzoni L, Verri M, Fortini F, Pavasini R, Morandi L, Biscaglia S, Di Ienno L, D'Aniello E, Manfrini M, Zoppellari R, Rizzo P, Ferrari R, Volta CA, Papi A, Spadaro S. Over time relationship between platelet reactivity, myocardial injury and mortality in patients with SARS-CoV-2-associated respiratory failure. Platelets. 2021 May 19;32(4):560-567. doi: 10.1080/09537104.2020.1852543. Epub 2020 Dec 3.

  PMID: 33270471 DERIVED

Study Officials

• Savino Spadaro, MD

  Intensive care unit

  PRINCIPAL INVESTIGATOR

• Gianluca Campo, MD

  Cardiology Unit

  PRINCIPAL INVESTIGATOR

• Marco Contoli, MD

  Pulmonology Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Technicians performing assays will be blinded to stage of the infection and outcomes
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 13, 2020
• Study Start: April 8, 2020
• Primary Completion: November 12, 2023
• Study Completion: December 7, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IT (1)