NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia
Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia

NCT04359511

WithdrawnPhase 3

Sponsor: University Hospital, Tours

Conditions: COVID-19

Interventions: Prednisone, Hydrocortisone

To date, there is no efficient therapeutics to prevent or treat COVID-19 related pulmonary failure. Corticosteroids (CS) could be a helpful therapeutic. Retrospective reports suggested survival improvement in patients with acute respiratory distress syndrome (ARDS). CT scan for COVID19 hospitalized patients showed sometimes unusual aspects of pneumonia, suggestive of an organizing phase of diffuse alveolar damage (DAD). We hypothesize that, in the context of alveolar aggression induced by COVID-19, CT scan could help to individualize patients with a high probability of pulmonary organizing process who could benefit from CS treatment.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Adult patients ≥ 18 years old,
* Hospitalized with a proven diagnosis of COVID-19 (SARS-CoV-2 positive in RTPCR), in medicine or in intensive care.
* With a need for oxygen therapy ≥ 2 l / min to maintain a Sp02\> 92% or a need for oxygen therapy to maintain a PaO2 / FiO2\> 300 mmHg (for intubated patients).
* With a chest scanner at least 7 days after the onset of symptoms, and whose centralized interpretation shows a CT scan aspect suggestive of intense and predominant DAD which can explain the patient's oxygen dependence.
* Signature of a free, written and informed consent by the patient, or the person of trust
* Affiliate or beneficiary of a social security scheme.

Exclusion Criteria:

* Patients already treated by CS for a chronic disease.
* Patients with a known contraindication to SC, such as hypersensitivity.
* Patients at risk of dying within 48 hours.
* Pregnant or breastfeeding women.
* Patients under guardianship, curatorship, safeguard of justice.
* Poor understanding of the French language.