Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT04619693
Eligibility Criteria:
Inclusion Criteria:
* Hospitalization for SARS-COV-2 pneumonia
* SARS-COV-2 infection proven by polymerase chain reaction (Nasopharyngeal or other respiratory sampling (expectoration, tracheal aspiration, bronchoalveolar lavage fluid)
* Presence of at least one of the following clinical signs of infectious pneumonia: fever (\>38°C), cough, dyspnoea, thoracic pain, crackling/rales
* Presence of at least one of the following on a lung computed tomography scan performed within two days of inclusion/randomisation: uni- or bilateral ground glass opacities, consolidations, alveolar condensations, inter- or intra-lobular reticulations, crazy paving
* Indication for dexamethasone corticotherapy (defined by the presence of hypoxemia with room-air SpO2 \<94% or a requirement for oxygen therapy to maintain Sp02 \>94%)
Exclusion Criteria:
* Systemic long-term anti-inflammatory treatment (corticosteroids or anti-interleukins) for chronic disease
* Systemic corticosteroid treatment in the 15 days preceding the eligibility visit (for disease other than COVID-19)
* Systemic corticosteroid treatment for COVID-19 started more than 48h before the eligibility visit
* Absolute contraindication for systemic corticosteroid treatment
* Aside from the current acute episode, life expectancy of \<6 months
* Patient unable to comply with all study procedures (e.g. contraindication for thoracic scans or bloodwork)
* Protected populations according to the French public health code (Pregnant, parturient or lactating women; adults under any form of guardianship; prisoners or persons under any form of judicial protection)
* Potential interference from other studies (Participation in any clinical trial of an investigational agent or procedure within one month prior to screening or during the study; exclusion period determined by another study.)
* It is impossible to correctly inform the patient (e.g. language barrier)
* Absence of free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)
* Non-beneficiary of the French social security, single-payer health insurance system
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04619693
Study Brief:
Protocol Section:
NCT04619693