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NCT Number: NCT04765371

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

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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Key information

Conditions

Coronavirus Infection Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Emergency, Hospital Victor Dupouy, Argenteuil, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Other names: DEXAMETHASONE Arm

Prednisolone

Drug

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

Other names: PREDNISOLONE Arm

Primary outcomes

  1. Mortality assessment at D28

    Time frame: At Day 28

    Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms

Secondary outcomes

  1. Assessment of clinical course in both groups (arms)

    Time frame: 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))

  2. Measurement of evolution of respiratory symptoms in both groups (arms)

    Time frame: 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

  3. Assessment of patient satisfaction towards the treatment

    Time frame: 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

  4. Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms)

    Time frame: 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

  5. Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms)

    Time frame: At Day 28

    Measurement of adverse events number and adverse effects number during the 28 days of the study

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, with CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study

Acronym: COPreDex

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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