Coronavirus Infection
Conditions
Keywords
Coronavirus Infections, SARS-CoV-2, Corticostéroïdes, Severe form of COVID-19
Brief 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.
Interventions
DRUGDEXAMETHASONE
Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10
DRUGPREDNISOLONE
Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10
Sponsors
Hôpital NOVO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient ≥ 18 years old * Patient with SARS-CoV-2 pneumopathy documented by nasopharyngeal or bronchoalveolar lavage fluid RT-PCR or any documented clinical symptoms support by CT scan * Patient with SpaO2 ≤ 94 % in room air (90% for patient with respiratory failure) and requiring an oxygen therapy * Negative pregnancy test for women of childbearing age * Informed and written informed consent (IC) obtained * Patients with affiliation to the social security system
Exclusion criteria
* Patient with corticosteroids as background treatment (≥ 10 mg equivalent) * Patient under supplemental oxygen \> 6 L/min * Immunocompromised patient (AIDS, bone marrow or solid organ transplants, etc.) * Patient who received a corticosteroid dose within 3 days for Covid-19 * Medical history of hypersensitivity to Prednisolone or Dexamethasone; or lactose / galactose (excipients with known effect) * Another active virus such hepatitis, herpes, varicella, shingles …. * Psychotic state not controlled by treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality assessment at D28 | At Day 28 | Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of clinical course in both groups (arms) | At Day 28 | 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 : * Number of oxygen therapy days, * Number of patients requiring oxygen therapy increase (High-Flow Oxygen Therapy, CPAP/BIPAP, mechanical ventilation, ECMO) * Number of hospital days * Number of patient admitted in Resuscitation Unit /Intensive care Unit * Number of patient with organic damage other than lung * Number of disease-related infection other than SARS-Cov-2 * Frequency and evolution of complication of corticosteroid therapy (Severity evaluated according to CTCAE (diabetes, acute psychosis or other adverse effect consider to be link to corticosteroide therapy by investigator)) |
| Measurement of evolution of respiratory symptoms in both groups (arms) | From Day 0 to Day 28 | 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 : * Oxygen saturation rate, * Oxygen flow, * Respiratory rate |
| Assessment of patient satisfaction towards the treatment | At Day 28 | Assessment of patient satisfaction with a satisfaction questionnaire (Likert-type scale) For each item, patient ticks : Very satisfied, Satisfied, Unsatisfied or Very unsatisfied |
| Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms) | At Day 1 and Day 28 | 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 |
| Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms) | At Day 28 | Measurement of adverse events number and adverse effects number during the 28 days of the study |
Countries
France
Outcome results
None listed