Coronavirus InfectionPhase 3COPreDexNCT04765371
Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, with CoViD-19
A Phase 3 study testing DEXAMETHASONE and PREDNISOLONE in people with Coronavirus Infection, run by Hôpital NOVO at 8 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- DEXAMETHASONE and PREDNISOLONE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 8 sitesFrance
- Study dates
- 3 Mar 2021to 10 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Department of Emergency, Hospital Victor Dupouy
Argenteuil, 95100
Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise
Beaumont
Department of Infectious and Tropical Diseases, Hospital Simone Veil
Eaubonne, 95600
Department of Infectious Medicine, Hospital of Gonesse
Gonesse, 95500
Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay
Le Puy-en-Velay, 43012
Department of Infectious and Tropical Diseases, Hospital René Dubos,
Pontoise, 95300
Department of Infectious and respiratory Diseases, Hospital Delafontaine
Saint-Denis, 93200
Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin
Saint-Quentin, 02321
About this study
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
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
Read the 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.
- Conditions
- Coronavirus Infection
- Being tested
- DEXAMETHASONE, PREDNISOLONE
- Keywords
- Coronavirus Infections, SARS-CoV-2, Corticostéroïdes, Severe form of COVID-19
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXAMETHASONEDrug
Also called DEXAMETHASONE Arm
Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10
PREDNISOLONEDrug
Also called PREDNISOLONE Arm
Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10
| Study group | Role | What they receive |
|---|---|---|
| DEXAMETHASONE Arm | Active comparator | Patients will take 6 mg per day of Dexamethasone during 10 days Receives: Drug: DEXAMETHASONE |
| PREDNISOLONE Arm | Active comparator | Patients will take 60 mg per day of Prednisolone during 10 days Receives: Drug: PREDNISOLONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality assessment at D28
Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms
Measured: At Day 28
Secondary outcomes (5)
Assessment of clinical course in both groups (arms)
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))
Measured: At Day 28
Measurement of evolution of respiratory symptoms in both groups (arms)
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
Measured: From Day 0 to Day 28
Assessment of patient satisfaction towards the treatment
Assessment of patient satisfaction with a satisfaction questionnaire (Likert-type scale) For each item, patient ticks : Very satisfied, Satisfied, Unsatisfied or Very unsatisfied
Measured: At Day 28
Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms)
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
Measured: At Day 1 and Day 28
Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms)
Measurement of adverse events number and adverse effects number during the 28 days of the study
Measured: At Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start3 Mar 2021
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Edouard DEVAUD, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765371
- Sponsor's protocol ID
- CHRD1520
- Other IDs
- 2020-005883-78
- Acronym
- COPreDex
- Status last verified
- May 2022
- First submitted
- 18 Feb 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04765371
- Acronym / sponsor ID
- COPreDex / CHRD1520
- Conditions
- Coronavirus Infection
- Keywords
- Coronavirus Infections, SARS-CoV-2, Corticostéroïdes, Severe form of COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEXAMETHASONE Arm | Active comparator | Drug: DEXAMETHASONEPatients will take 6 mg per day of Dexamethasone during 10 days |
| PREDNISOLONE Arm | Active comparator | Drug: PREDNISOLONEPatients will take 60 mg per day of Prednisolone during 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXAMETHASONEAlso: DEXAMETHASONE ArmPatients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10 | Drug | DEXAMETHASONE Arm |
| PREDNISOLONEAlso: PREDNISOLONE ArmPatients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10 | Drug | PREDNISOLONE Arm |
Primary outcome
Mortality assessment at D28
Time frame: At Day 28
Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms
5 secondary outcomes
Assessment of clinical course in both groups (arms)
Time frame: At Day 28
Measurement of evolution of respiratory symptoms in both groups (arms)
Time frame: From Day 0 to Day 28
Assessment of patient satisfaction towards the treatment
Time frame: At Day 28
Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms)
Time frame: At Day 1 and Day 28
Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms)
Time frame: At Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Edouard DEVAUD principal investigator
Hôpital NOVO
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DEXAMETHASONE and PREDNISOLONE in people with Coronavirus Infection, run by Hôpital NOVO at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality assessment at D28 (time frame: At Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.