COVID-19 PneumoniaCHOD-1NCT04889261
External Validation of the CHOD Risk Scale
An observational study of COVID-19 Pneumonia and Pulmonary Embolism, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, Pulmonary Embolism
- How many people
- 245 participants
- Where
- 1 siteSpain
- Study dates
- 17 May 2021to 31 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- Hospitalization for COVID-19 pneumonia
- More than 5 days from the date of onset of symptoms (this criterion can be met during hospitalization).
- 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).
Who cannot join
- Pregnancy.
- Age <18 years.
- Hemodynamic instability: SBP <90 mmHg or vasopressors to achieve ≥ 90 mmHg.
- Contraindication for performing CT angiography:
- Severe kidney failure (GFR <30)
- Allergy to iodinated contrasts.
- Intolerance to decubitus.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
David de la Rosa, drosa@santpau.cat
About this study
Official title: 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.
Read more
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.
- Conditions
- COVID-19 Pneumonia, Pulmonary Embolism
- Keywords
- COVID-19, Pulmonary embolism, CT angiography, Screening test
- Medical subject headings
- Pulmonary Embolism, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
CHOD risk scale value
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.
Measured: At least 5 days after the onset of symptoms
Secondary outcomes (1)
Incidence of pulmonary embolism
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start17 May 2021
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889261
- Sponsor's protocol ID
- IIBSP-COV-2021-53
- Acronym
- CHOD-1
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Risk of Pulmonary Thromboembolism in Patients Hospitalized for COVID-19 Pneumonia: External Validation of the CHOD Risk Scale.
- ClinicalTrials.gov ID
- NCT04889261
- Acronym / sponsor ID
- CHOD-1 / IIBSP-COV-2021-53
- Conditions
- COVID-19 Pneumonia, Pulmonary Embolism
- Keywords
- COVID-19, Pulmonary embolism, CT angiography, Screening test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Diagnostic confirmation of SARS-CoV-2 infection by positive result in at least one test:
- Hospitalization for COVID-19 pneumonia
- More than 5 days from the date of onset of symptoms (this criterion can be met during hospitalization).
- Elevated D-dimer, by any of the following criteria:
Key exclusion criteria (7 listed)
- Pregnancy.
- Age <18 years.
- Hemodynamic instability: SBP <90 mmHg or vasopressors to achieve ≥ 90 mmHg.
- Contraindication for performing CT angiography:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Incidence of pulmonary embolism
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and Pulmonary Embolism, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David de la Rosa, MD (+34935537813, drosa@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHOD risk scale value (time frame: At least 5 days after the onset of symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2021.