External Validation of the CHOD Risk Scale (CHOD-1)

May 17, 2021 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Predicting the Risk of Pulmonary Thromboembolism in Patients Hospitalized for COVID-19 Pneumonia: External Validation of the CHOD Risk Scale.

Severe COVID-19 is associated with a hypercoagulable state, with a high risk of thrombotic phenomena such as pulmonary thromboembolism (PE). Its diagnostic suspicion is complicated, due to the overlap of symptoms of PE with those of COVID-19 itself. Therefore, it is essential to improve PE prediction to optimise the performance of confirmatory imaging tests such as thoracic CT angiography. Early diagnosis has relevant therapeutic implications, as it justifies starting anticoagulant treatment early, with a possible positive impact on the clinical evolution of these patients.

The CHOD risk scale has recently been described: the acronym for C-reactive protein concentration, heart rate, oxygen saturation, and D-Dimer levels. Its initial description was carried out in a study in a single hospital centre. proving to be an easy-to-apply tool, useful for predicting the appearance of PE in patients hospitalized for COVID-19.

The objective of this study is to carry out an external validation of this scale in patients hospitalized for COVID-19 pneumonia, through an observational, cross-sectional, multicenter, real-life study in patients hospitalized for severe COVID-19 pneumonia, confirmed by objective methods, and showing high D-dimer values.

Imaging tests with CT angiography will be performed in patients with elevated D-Dimer, following international clinical practice regulations. Given that they will be consecutive patients, CT angiography will be performed in all patients regardless of the patient's clinical probability of PE as long as they meet the inclusion criteria and none of the exclusion criteria.

To calculate the PE predictive power of the CHOD scale in the validation cohort, a methodology similar to that used in the construction cohort will be used, that is, the use of a ROC curve.

Taking into account that a similar predictive value (with a maximum error of 5%) between the CHOD scale in the construction cohort and that of this study (validation cohort) will be considered as an adequate external validation, and taking into account a statistical power of 80%, an alpha error of 5% and a maximum loss of patients of 15%, the required sample size is 245 patients. Since 7 centres initially participate, each of which will have to contribute 35 valid consecutive patients for the analysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Study Type

Study Type

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Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
245

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Claudia Erika Delgado Espinoza
  • Phone Number: +34935537813
  • Email: uicec@santpau.cat

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de La Santa Creu I Sant Pau
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients hospitalized for pneumonia caused by SARS-CoV-2 confirmed by objective methods, and with elevated D-dimer values.

Since it is a prevalence and validation study, pulmonary artery CT angiography will be performed consecutively in all patients (regardless of the pre-test clinical probability of PE that they present) who meet the criteria defined in the construction study of the CHOD risk scale, and that are managed by the group of participating physicians. The random assignment of admitted patients by the inpatient department manager to participating physicians ensures that the sample is representative of the admissions set, which will then allow inferences to be established without the need to establish a priori randomization that would imply ethical aspects.

Description

Inclusion Criteria:

  1. Diagnostic confirmation of SARS-CoV-2 infection by positive result in at least one test:

    • Rapid nasopharyngeal smear antigen test.
    • PCR smear or nasopharyngeal aspirate.
    • Sputum PCR.
    • PCR of bronchoalveolar lavage.
    • Positive IgM in the serology for SARS-CoV2
  2. Hospitalization for COVID-19 pneumonia
  3. More than 5 days from the date of onset of symptoms (this criterion can be met during hospitalization).

  4. Elevated D-dimer, by any of the following criteria:

    • DD> 500 ng/ml; In the case of patients over 50 years of age, the DD cut-off point adjusted for age (age x 10) will be applied.
    • With the DDU measurement, the cut-off point is 250 mg/dl (instead of 500) and the adjustments for age in those over 50 years are made by multiplying the age x 5 (instead of x 10).

Exclusion Criteria:

  1. Pregnancy.
  2. Age <18 years.
  3. Hemodynamic instability: SBP <90 mmHg or vasopressors to achieve ≥ 90 mmHg.

  4. Contraindication for performing CT angiography:

    • Severe kidney failure (GFR <30)
    • Allergy to iodinated contrasts.
    • Intolerance to decubitus.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CHOD risk scale value
Time Frame: At least 5 days after the onset of symptoms
External validation of the CHOD risk scale (an acronym of C-reactive protein concentration + Heart rate + Oxygen saturation + D-Dimer levels) in patients hospitalized for confirmed COVID-19 pneumonia in the usefulness for the diagnosis of PE. The scale ranges from 0 to 7 points. The probability of incident PE during the hospitalization is low (4.5%) at 0-2 points, moderate (36.8%) at 3-5 points, and high (100%) at 6-7 points.
At least 5 days after the onset of symptoms

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of pulmonary embolism
Time Frame: 1 year
To establish the frequency of PE in patients hospitalized for COVID-19 pneumonia with elevated D-Dimer, during the time it takes to complete the expected sample of 235 patients.
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIBSP-COV-2021-53

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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