Official Title
Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia in Grand Ouest Interregion France
Brief Summary

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.

Detailed Description

"Severe acute respiratory syndrome" coronavirus 2 (SARS-Cov-2) is a new coronavirus that
induces pneumonia called Corona Virus Disease- 19 (COVID-19), an infected 1.5 million people
worldwide and caused the more than 85,000 patients died. COVID-19 usually comes in the form
of viral pneumonia but with the peculiarities of a risk frequent worsening towards acute
respiratory distress syndrome (ARDS) and a usual duration of oxygen dependence in fragile
patients by their age or their comorbidities. To date, there is no therapy effective in
preventing or treating COVID-19. Drug identification is a major concern and a public health
emergency. Retrospective study (Wu 2020) highlighted improved survival in COVID-19 patients
with acute ARDS and treated with corticosteroids (CS). So even in the absence of evidence of
effectiveness, the SCs are used for COVID-19 oxygen-dependent patients or with an ARDS.
However, their benefit / risk remains debated (Russel 2020). On histological samples of
COVID-19, diffuse alveolar damage (DAD) has been especially observed (Hanley 2020). DAD is
described histologically in an exudative phase, an organizational phase and a irreversible
fibrotic phase (Hughes 2017). SC could have an effect beneficial by limiting the exudative /
inflammatory phase but also that organization whose histological and CT aspects are sometimes
indistinguishable from organized pneumonia, a form of pulmonary repair aberrant very
corticosensitive (Travis 2013). Chest scans performed in the face of the persistence or
worsening of oxygen dependence beyond the 7th day of COVID-19 symptoms, could help discern
indirect complications (pulmonary embolism, exacerbation of COPD, bacterial superinfection,
etc.) of an unfavorable course COVID-19 (by displaying an aspect suggesting DAD in particular
during the organization phase). We hypothesize that, in the context of COVID-19, the SCs may
be beneficial in patients with CT scans thoracic images suggestive of DAD either at the
exudative phase or at the pulmonary organization phase.

Withdrawn
COVID-19

Drug: Prednisone

prednisone 0.7 mg/kg/d (PO)

Drug: Hydrocortisone

hémisuccinate d'hydrocortisone 3,5 mg/kg/jour (IV)

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
University Hospital, Tours
NCT Number
MeSH Terms
COVID-19
Pneumonia
Prednisone
Hydrocortisone