Clinical trial NCT04765371: Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, with CoViD-19
Official title: Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, with CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronavirus Infection
Keywords: Coronavirus Infections
SARS-CoV-2
Corticostéroïdes
Severe form of COVID-19
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality assessment at D28
timeFrame: At Day 28
Secondary outcomes:
measure: Assessment of clinical course in both groups (arms)
timeFrame: At Day 28
measure: Measurement of evolution of respiratory symptoms in both groups (arms)
timeFrame: From Day 0 to Day 28
measure: Assessment of patient satisfaction towards the treatment
timeFrame: At Day 28
measure: Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms)
timeFrame: At Day 1 and Day 28
measure: Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms)
timeFrame: At Day 28
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Department of Emergency, Hospital Victor Dupouy
city: Beaumont
country: France
facility: Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise
city: Eaubonne
country: France
facility: Department of Infectious and Tropical Diseases, Hospital Simone Veil
city: Gonesse
country: France
facility: Department of Infectious Medicine, Hospital of Gonesse
city: Le Puy-en-Velay
country: France
facility: Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay
city: Pontoise
country: France
facility: Department of Infectious and Tropical Diseases, Hospital René Dubos,
city: Saint-Denis
country: France
facility: Department of Infectious and respiratory Diseases, Hospital Delafontaine
city: Saint-Quentin
country: France
facility: Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin
Study officials:
affiliation: Hôpital NOVO
name: Dr Edouard DEVAUD
role: PRINCIPAL_INVESTIGATOR
References: