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

Hôpital NOVO

Status and phase

Completed

Phase 3

Conditions

Coronavirus Infection

Treatments

Drug: DEXAMETHASONE

Drug: PREDNISOLONE

Study type

Interventional

Funder types

Other

Identifiers

NCT04765371

CHRD1520

2020-005883-78 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

89 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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