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NCT Number: NCT04370249

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

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Nantes

Nantes, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulmonary ultrasound

Other

pulmonary ultrasound on admission

Primary outcomes

  1. 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

    Time frame: 48 hours post-admission

    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

Secondary outcomes

  1. Evaluate the prognostic performance of the VIRUScore on the risk of pulmonary aggravation

    Time frame: 48 hours post-admission

    Sensitivity, specificity, positive predictive value, negative predictive value of VIRUScore on risk of pulmonary aggravation

  2. 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).

    Time frame: 14 days post-admission

    Sensitivity, specificity, positive predictive value, negative predictive value of VIRUScore on the risk of severe pulmonary aggravation defined by resuscitation admission and/or death.

  3. Construction of a decisional algorithm for triage and management of COVID-19 patients.

    Time frame: 14 days post-admission

    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.

  4. 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.

    Time frame: 14 days post-admission

    Search for "Ultrasound signature" (lung fields and/or severity of damage) associated with mild vs. moderate (oxygen therapy) vs. severe (resuscitation/death) clinical forms.

  5. Evaluate the analytical concordance between the pulmonary ultrasound (LUScore) and the Gold-standard CT-scan (CT score)

    Time frame: 14 days post-admission

    Diagnostic concordance of the LUScore and CT score with the severity grades defined by the French Radiology Society

  6. Construction of a score predictive of aggravation in the sub-population of patients returned home

    Time frame: 14 days post-admission

    Predictive Score for Aggravation in Patients Returned Home

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • WINFOCUS-France

Registry information

Acronym: VIRUS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2020
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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