A Phase 3 interventional study of Prednisone and Hydrocortisone in COVID-19, sponsored by University Hospital, Tours. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by University Hospital, Tours · Phase 3, Interventional, and Treatment
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.
"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.
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Exclusion Criteria:
* prednisone 0.7 mg/kg/day for 10 days, administered orally, once a day, or * hydrocortisone hemisuccinate 3.5 mg/kg/day by continuous infusion for 10 days, administered by IV route if the patient cannot take drugs by oral route, * standard of care
Drug: Prednisone · Drug: Hydrocortisone
standard of care
prednisone 0.7 mg/kg/d (PO)
hémisuccinate d'hydrocortisone 3,5 mg/kg/jour (IV)
Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days.
The 7-category ordinal scale is as follow: 1. Not hospitalized with resumption of usual activities 2. Not hospitalized, but unable to resume usual activities 3. Hospitalized, not requiring O2 4. Hospitalized, requiring O2 from 1 to 5 l/min 5. Hospitalized, requiring O2 \>6 l/min, nasal high-flow O2, non-invasive mechanical ventilation, or both 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death.
Time frame: 14 days
Proportion of patients free of oxygen at day 14 and 28
Time frame: 14 and 28 days
Proportion of patients discharged alive from hospital at day 14 and 28
Time frame: 14 and 28 days
Time to discharge for patients alive
Time frame: 28 days
Proportion of patients that were hospitalized to ICU or who died at day 14 and 28
Time frame: 14 and 28 days
14 and 28 day mortality rate
Time frame: 14 and 28 days
The time until weaning from oxygen therapy
Time frame: 28 days
The proportion of patients with clinical degradation of at least 1 point on the ordinal scale to 7 categories on D14 and D28
Time frame: 14 and 28 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
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University Hospital, Tours