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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005883-78 | EudraCT Number |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEXAMETHASONE Arm | Active Comparator | Patients will take 6 mg per day of Dexamethasone during 10 days |
|
| PREDNISOLONE Arm | Active Comparator | Patients will take 60 mg per day of Prednisolone during 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEXAMETHASONE | Drug | Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality assessment at D28 | Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms | At Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of clinical course in both groups (arms) | The clinical course for each patient will be measured, for several items, and compared between both groups to see if a significant difference is observed. Items, considered for comparison, are listed below :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Edouard DEVAUD | HĂ´pital NOVO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Emergency, Hospital Victor Dupouy | Argenteuil | 95100 | France | |||
| Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| PREDNISOLONE | Drug | Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10 |
|
|
| At Day 28 |
| Measurement of evolution of respiratory symptoms in both groups (arms) | Evolution of respiratory symptoms will be measured for each patient, for several items, and compared between both groups to see if a significant difference is observed. Items, considered for comparison, are listed below :
| From Day 0 to Day 28 |
| Assessment of patient satisfaction towards the treatment | Assessment of patient satisfaction with a satisfaction questionnaire (Likert-type scale) For each item, patient ticks : Very satisfied, Satisfied, Unsatisfied or Very unsatisfied | At Day 28 |
| Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms) | Measurement of patient quality of life evolution with EQ5D self-assessment questionnaire at day1 and day 28. For item of mobility, autonomy and current activities, patient ticks : I have no problem, I have some problems or I am I am unable to do For item of pain and anxiety/depression, patient ticks : no, moderate or severe | At Day 1 and Day 28 |
| Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms) | Measurement of adverse events number and adverse effects number during the 28 days of the study | At Day 28 |
| Beaumont |
| France |
| Department of Infectious and Tropical Diseases, Hospital Simone Veil | Eaubonne | 95600 | France |
| Department of Infectious Medicine, Hospital of Gonesse | Gonesse | 95500 | France |
| Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay | Le Puy-en-Velay | 43012 | France |
| Department of Infectious and Tropical Diseases, Hospital René Dubos, | Pontoise | 95300 | France |
| Department of Infectious and respiratory Diseases, Hospital Delafontaine | Saint-Denis | 93200 | France |
| Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin | Saint-Quentin | 02321 | France |
| D007239 |
| Infections |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |