NCT04765371

Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, with CoViD-19

Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, with CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Hôpital NOVO · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate two differents regimens of corticosteroids (prednisolone versus dexamethasone) on D28 mortality in patients with CoViD 19 pneumonia requiring oxygen supplementation

Detailed description

Low-dose glucocorticoid treatment is the only medication showing a significant reduction in mortality in cases of COVID-19 pneumonia requiring oxygen supplementation or ventilatory support. Intravenous or oral dexamethasone are well evaluated in randomized study but other oral corticosteroids are not. Compared to dexamethasone, prednisolone is more available in France and easily taken by patients, especially in case of home medical care. The pharmacokinetics/pharmacodynamics of prednisolone and dexamethasone are different. To obtain similar effects, prednisolone should be theoretically taken twice a day and at a superior dose than the strict prednisone equivalence of 6mg dexamethasone.

Conditions

• Coronavirus Infection

Interventions

Type	Name	Description
DRUG	DEXAMETHASONE	Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10
DRUG	PREDNISOLONE	Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10

Timeline

• Start date: 2021-03-03
• Primary completion: 2022-02-10
• Completion: 2022-02-10
• First posted: 2021-02-21
• Last updated: 2024-09-19

Locations

8 sites across 1 country: France