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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2022-02-10

Brief Summary

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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

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Detailed Description

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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

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Coronavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DEXAMETHASONE Arm

Patients will take 6 mg per day of Dexamethasone during 10 days

Group Type ACTIVE_COMPARATOR

DEXAMETHASONE

Intervention Type DRUG

Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10

PREDNISOLONE Arm

Patients will take 60 mg per day of Prednisolone during 10 days

Group Type ACTIVE_COMPARATOR

PREDNISOLONE

Intervention Type DRUG

Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10

Interventions

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DEXAMETHASONE

Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10

Intervention Type DRUG

PREDNISOLONE

Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10

Intervention Type DRUG

Other Intervention Names

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DEXAMETHASONE Arm PREDNISOLONE Arm

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No