Construction of a Composite Clinical-echo Score Predictive of a Risk of Short-term Aggravation of Respiratory Impairment in Patients Suspected of Covid-19

COVID-19 Clinical Trial

— VIRUS  

Official title:

Construction of a Composite Clinical-echo Score Predictive of a Risk of Short-term Aggravation of Respiratory Impairment in Patients Suspected of Covid-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370249
• Other study ID #: RC20_0164
• Status: Completed
• Start date: April 9, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With the influx of patients suspected of Covid-19 and the limited number of hospital beds, there is a need for sensitive triage to detect patients at risk of pulmonary complications and therefore requiring hospitalization, but also specific triage to safely discharge patients without risk factors or signs of clinical or ultrasound severity. The use of pulmonary ultrasound in addition to clinical assessment seems appropriate. Indeed, it allows early detection of signs of pneumopathy which, in the current context, most often correspond to Covid-19. These signs include B-lines, which indicate interstitial pulmonary oedema, and an anfractuous and thickened pleural line, or even centimetric parenchymal condensations with a low level of pleural effusion. Conversely, the presence of a medium to large pleural effusion is not very suggestive of the diagnosis of Covid-19. In addition, a lung ultrasound score has been developed and validated to assess the severity of acute respiratory distress and predict the occurrence of acute respiratory distress syndrome. It is based on the performance of a 12-point (6 per hemi-thorax) pulmonary ultrasound with the collection of the presence of B-lines, condensation or pleural effusion. In the hands of a trained operator, this examination takes only a few minutes.

The aim of the study is to develop a score based on clinical and ultrasound evidence to allow early and safer referral than that based on clinical evidence alone. To do this, the study will retrospectively collect clinical and lung ultrasound data from departments that use this technique on a daily basis.

Description:

The objective of the VIRUS research is therefore to develop an innovative clinical-echo score (VIRUScore), based on risk factors, clinical elements and ultrasound data. This predictive score corresponds to a probabilistic measure of the individual risk of aggravation and is intended to become the cornerstone of a decision-making algorithm for triaging/managing COVID-19 patients (VIRUS algorithm). Initial VIRUScore and evolution of clinical and/or clinico-biological signs will thus have to arbitrate different patient pathway scenarios with 2 major objectives: first, to reduce hospital tension and desaturate emergency departments and COVID-19 units to ensure maximum monitoring of moderate forms, some of which are likely to evolve towards severe forms. The negative predictive value of severe short-term aggravation (H48) should therefore be maximized for these patient profiles invited to return home and/or transfer to non-specialized hospitals or clinics. And secondly, it should be sensitive in detecting and predicting the most severe forms with a high risk of resuscitative escalation and/or death, allowing prioritization (access to CT, access to research protocols) and grading the intensity of clinical surveillance, for anticipation of resuscitative resources.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted and managed in an emergency department under suspicion of COVID-19 who received a pleuro-pulmonary ultrasound on admission

Exclusion Criteria:

• Patients admitted and treated in an Emergency Department for suspected COVID-19 but who did not receive a pleuro-pulmonary ultrasound on admission

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Other:
• pulmonary ultrasound
pulmonary ultrasound on admission

Locations

Country	Name	City	State
France	Chu de Nantes	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	WINFOCUS-France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Construction of a composite clinical-echo score (VIRUScore) predictive of risk of worsening respiratory impairment in COVID-19 adult patients admitted to the Emergency Department	Multivariate model predictive of clinical worsening of respiratory impairment within 48 hours post-admission : intubation, oxygenotherapy, need of vasoactive drugs, worsening of state,age, gender, body surface, LUScore (pulmonary ultrasound), FiO2, need of ventral decubitus, risk factor (obesity, asthma...), time from the beginning of the first symptoms	48 hours post-admission
Secondary	Evaluate the prognostic performance of the VIRUScore on the risk of pulmonary aggravation	Sensitivity, specificity, positive predictive value, negative predictive value of VIRUScore on risk of pulmonary aggravation	48 hours post-admission
Secondary	Evaluate the prognostic performance of the VIRUScore on the risk of severe pulmonary aggravation defined by resuscitation admission and/or death at D14 (sensitivity, specificity, positive predictive value, negative predictive value).	Sensitivity, specificity, positive predictive value, negative predictive value of VIRUScore on the risk of severe pulmonary aggravation defined by resuscitation admission and/or death.	14 days post-admission
Secondary	Construction of a decisional algorithm for triage and management of COVID-19 patients.	Research of VIRUScore cut-off values maximizing the negative predictive value and construction of a decisional algorithm maximizing returns home and transfers to non-specialized hospitals or clinics without loss of individual chance.	14 days post-admission
Secondary	Search for "ultrasound signature" (lung fields and/or severity of involvement) associated with mild (return home) vs. moderate (oxygen therapy) vs. severe (resuscitation/death) clinical forms.	Search for "Ultrasound signature" (lung fields and/or severity of damage) associated with mild vs. moderate (oxygen therapy) vs. severe (resuscitation/death) clinical forms.	14 days post-admission
Secondary	Evaluate the analytical concordance between the pulmonary ultrasound (LUScore) and the Gold-standard CT-scan (CT score)	Diagnostic concordance of the LUScore and CT score with the severity grades defined by the French Radiology Society	14 days post-admission
Secondary	Construction of a score predictive of aggravation in the sub-population of patients returned home	Predictive Score for Aggravation in Patients Returned Home	14 days post-admission