COVID-19Phase 3CORTICOVIDHUGONCT04359511
Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia
A Phase 3 study testing Prednisone and Hydrocortisone in people with COVID-19, run by University Hospital, Tours.
Trial summary
To date, there is no efficient therapeutics to prevent or treat COVID-19 related pulmonary failure. Corticosteroids (CS) could be a helpful therapeutic. Retrospective reports suggested survival improvement in patients with acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Prednisone and Hydrocortisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Jul 2020to 3 Jul 2020
- 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
- Adult patients ≥ 18 years old,
- Hospitalized with a proven diagnosis of COVID-19 (SARS-CoV-2 positive in RTPCR), in medicine or in intensive care.
- With a need for oxygen therapy ≥ 2 l / min to maintain a Sp02> 92% or a need for oxygen therapy to maintain a PaO2 / FiO2> 300 mmHg (for intubated patients).
- With a chest scanner at least 7 days after the onset of symptoms, and whose centralized interpretation shows a CT scan aspect suggestive of intense and predominant DAD which can explain the patient's oxygen dependence.
- Signature of a free, written and informed consent by the patient, or the person of trust
- Affiliate or beneficiary of a social security scheme.
Who cannot join
- Patients already treated by CS for a chronic disease.
- Patients with a known contraindication to SC, such as hypersensitivity.
- Patients at risk of dying within 48 hours.
- Pregnant or breastfeeding women.
- Patients under guardianship, curatorship, safeguard of justice.
- Poor understanding of the French language.
About this study
Official title: Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia in Grand Ouest Interregion France
To date, there is no efficient therapeutics to prevent or treat COVID-19 related pulmonary failure. Corticosteroids (CS) could be a helpful therapeutic. Retrospective reports suggested survival improvement in patients with acute respiratory distress syndrome (ARDS). CT scan for COVID19 hospitalized patients showed sometimes unusual aspects of pneumonia, suggestive of an organizing phase of diffuse alveolar damage (DAD).
We hypothesize that, in the context of alveolar aggression induced by COVID-19, CT scan could help to individualize patients with a high probability of pulmonary organizing process who could benefit from CS treatment.
Read the detailed description
"Severe acute respiratory syndrome" coronavirus 2 (SARS-Cov-2) is a new coronavirus that induces pneumonia called Corona Virus Disease- 19 (COVID-19), an infected 1.5 million people worldwide and caused the more than 85,000 patients died. COVID-19 usually comes in the form of viral pneumonia but with the peculiarities of a risk frequent worsening towards acute respiratory distress syndrome (ARDS) and a usual duration of oxygen dependence in fragile patients by their age or their comorbidities. To date, there is no therapy effective in preventing or treating COVID-19. Drug identification is a major concern and a public health emergency. Retrospective study (Wu 2020) highlighted improved survival in COVID-19 patients with acute ARDS and treated with corticosteroids (CS). So even in the absence of evidence of effectiveness, the SCs are used for COVID-19 oxygen-dependent patients or with an ARDS. However, their benefit / risk remains debated (Russel 2020). On histological samples of COVID-19, diffuse alveolar damage (DAD) has been especially observed (Hanley 2020). DAD is described histologically in an exudative phase, an organizational phase and a irreversible fibrotic phase (Hughes 2017). SC could have an effect beneficial by limiting the exudative / inflammatory phase but also that organization whose histological and CT aspects are sometimes indistinguishable from organized pneumonia, a form of pulmonary repair aberrant very corticosensitive (Travis 2013). Chest scans performed in the face of the persistence or worsening of oxygen dependence beyond the 7th day of COVID-19 symptoms, could help discern indirect complications (pulmonary embolism, exacerbation of COPD, bacterial superinfection, etc.) of an unfavorable course COVID-19 (by displaying an aspect suggesting DAD in particular during the organization phase). We hypothesize that, in the context of COVID-19, the SCs may be beneficial in patients with CT scans thoracic images suggestive of DAD either at the exudative phase or at the pulmonary organization phase.
- Conditions
- COVID-19
- Being tested
- Prednisone, Hydrocortisone
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
prednisone 0.7 mg/kg/d (PO)
HydrocortisoneDrug
hémisuccinate d'hydrocortisone 3,5 mg/kg/jour (IV)
| Study group | Role | What they receive |
|---|---|---|
| corticosteroid + Optimized Standard of Care | Experimental | * prednisone 0.7 mg/kg/day for 10 days, administered orally, once a day, or
* hydrocortisone hemisuccinate 3.5 mg/kg/day by continuous infusion for 10 days, administered by IV route if the patient cannot take drugs by oral route,
* standard of care Receives: Drug: Prednisone; Drug: Hydrocortisone |
| Optimized Standard of Care | No intervention | standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days.
The 7-category ordinal scale is as follow:
- Not hospitalized with resumption of usual activities
- Not hospitalized, but unable to resume usual activities
- Hospitalized, not requiring O2
- Hospitalized, requiring O2 from 1 to 5 l/min
- Hospitalized, requiring O2 >6 l/min, nasal high-flow O2, non-invasive mechanical ventilation, or both
- Hospitalized, requiring ECMO, invasive mechanical ventilation, or both
- Death.
Measured: 14 days
Secondary outcomes (7)
Proportion of patients free of oxygen at day 14 and 28
Measured: 14 and 28 days
Proportion of patients discharged alive from hospital at day 14 and 28
Measured: 14 and 28 days
Time to discharge for patients alive
Measured: 28 days
Proportion of patients that were hospitalized to ICU or who died at day 14 and 28
Measured: 14 and 28 days
14 and 28 day mortality rate
Measured: 14 and 28 days
The time until weaning from oxygen therapy
Measured: 28 days
The proportion of patients with clinical degradation of at least 1 point on the ordinal scale to 7 categories on D14 and D28
Measured: 14 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start3 Jul 2020
- Primary completion3 Jul 2020
- Study completion3 Jul 2020 (estimated)
Why it stopped: COMPETITOR TEST (RECOVERY)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOUIS BERNARD, MD, PhD, Principal investigator, CHRU DE TOURSJOUNEAU STEPHANE, MD, PhD, Principal investigator, Rennes University HospitalMAILLOT FRANCOIS, MD, Principal investigator, CHRU DE TOURSLIOGER BERTRAND, MD, Principal investigator, CH DE BLOISGOUPIL FRANCOIS, MD, Principal investigator, CH Le MansRABUT Thi- Tuyet Hong, MD, Principal investigator, CH DE CHARTRESPOPA Mihai, MD, Principal investigator, CH DE RDREUXMOREL HUGUES, MD, Principal investigator, CHR ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359511
- Sponsor's protocol ID
- CORTI-COVID-19-HUGO
- Other IDs
- DR200136
- Acronym
- CORTICOVIDHUGO
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia in Grand Ouest Interregion France
- ClinicalTrials.gov ID
- NCT04359511
- Acronym / sponsor ID
- CORTICOVIDHUGO / CORTI-COVID-19-HUGO
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COMPETITOR TEST (RECOVERY)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 3 Jul 2020 (estimated)
- First posted
- 24 Apr 2020 (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.
To date, there is no efficient therapeutics to prevent or treat COVID-19 related pulmonary failure. Corticosteroids (CS) could be a helpful therapeutic. Retrospective reports suggested survival improvement in patients with acute respiratory distress syndrome (ARDS). CT scan for COVID19 hospitalized patients showed sometimes unusual aspects of pneumonia, suggestive of an organizing phase of diffuse alveolar damage (DAD).
We hypothesize that, in the context of alveolar aggression induced by COVID-19, CT scan could help to individualize patients with a high probability of pulmonary organizing process who could benefit from CS treatment.
Detailed description
"Severe acute respiratory syndrome" coronavirus 2 (SARS-Cov-2) is a new coronavirus that induces pneumonia called Corona Virus Disease- 19 (COVID-19), an infected 1.5 million people worldwide and caused the more than 85,000 patients died. COVID-19 usually comes in the form of viral pneumonia but with the peculiarities of a risk frequent worsening towards acute respiratory distress syndrome (ARDS) and a usual duration of oxygen dependence in fragile patients by their age or their comorbidities. To date, there is no therapy effective in preventing or treating COVID-19. Drug identification is a major concern and a public health emergency. Retrospective study (Wu 2020) highlighted improved survival in COVID-19 patients with acute ARDS and treated with corticosteroids (CS). So even in the absence of evidence of effectiveness, the SCs are used for COVID-19 oxygen-dependent patients or with an ARDS. However, their benefit / risk remains debated (Russel 2020). On histological samples of COVID-19, diffuse alveolar damage (DAD) has been especially observed (Hanley 2020). DAD is described histologically in an exudative phase, an organizational phase and a irreversible fibrotic phase (Hughes 2017). SC could have an effect beneficial by limiting the exudative / inflammatory phase but also that organization whose histological and CT aspects are sometimes indistinguishable from organized pneumonia, a form of pulmonary repair aberrant very corticosensitive (Travis 2013). Chest scans performed in the face of the persistence or worsening of oxygen dependence beyond the 7th day of COVID-19 symptoms, could help discern indirect complications (pulmonary embolism, exacerbation of COPD, bacterial superinfection, etc.) of an unfavorable course COVID-19 (by displaying an aspect suggesting DAD in particular during the organization phase). We hypothesize that, in the context of COVID-19, the SCs may be beneficial in patients with CT scans thoracic images suggestive of DAD either at the exudative phase or at the pulmonary organization phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corticosteroid + Optimized Standard of Care | Experimental | Drug: Prednisone, Drug: Hydrocortisone* prednisone 0.7 mg/kg/day for 10 days, administered orally, once a day, or * hydrocortisone hemisuccinate 3.5 mg/kg/day by continuous infusion for 10 days, administered by IV route if the patient cannot take drugs by oral route, * standard of care |
| Optimized Standard of Care | No intervention | –standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients ≥ 18 years old,
- Hospitalized with a proven diagnosis of COVID-19 (SARS-CoV-2 positive in RTPCR), in medicine or in intensive care.
- With a need for oxygen therapy ≥ 2 l / min to maintain a Sp02> 92% or a need for oxygen therapy to maintain a PaO2 / FiO2> 300 mmHg (for intubated patients).
- With a chest scanner at least 7 days after the onset of symptoms, and whose centralized interpretation shows a CT scan aspect suggestive of intense and predominant DAD which can explain the patient's oxygen dependence.
- Signature of a free, written and informed consent by the patient, or the person of trust
Key exclusion criteria (6 listed)
- Patients already treated by CS for a chronic disease.
- Patients with a known contraindication to SC, such as hypersensitivity.
- Patients at risk of dying within 48 hours.
- Pregnant or breastfeeding women.
- Patients under guardianship, curatorship, safeguard of justice.
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 |
|---|---|---|
| Prednisoneprednisone 0.7 mg/kg/d (PO) | Drug | corticosteroid + Optimized Standard of Care |
| Hydrocortisonehémisuccinate d'hydrocortisone 3,5 mg/kg/jour (IV) | Drug | corticosteroid + Optimized Standard of Care |
Primary outcome
Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days.
Time frame: 14 days
The 7-category ordinal scale is as follow: 1. Not hospitalized with resumption of usual activities 2. Not hospitalized, but unable to resume usual activities 3. Hospitalized, not requiring O2 4. Hospitalized, requiring O2 from 1 to 5 l/min 5. Hospitalized, requiring O2 >6 l/min, nasal high-flow O2, non-invasive mechanical ventilation, or both 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death.
7 secondary outcomes
Proportion of patients free of oxygen at day 14 and 28
Time frame: 14 and 28 days
Proportion of patients discharged alive from hospital at day 14 and 28
Time frame: 14 and 28 days
Time to discharge for patients alive
Time frame: 28 days
Proportion of patients that were hospitalized to ICU or who died at day 14 and 28
Time frame: 14 and 28 days
14 and 28 day mortality rate
Time frame: 14 and 28 days
The time until weaning from oxygen therapy
Time frame: 28 days
The proportion of patients with clinical degradation of at least 1 point on the ordinal scale to 7 categories on D14 and D28
Time frame: 14 and 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
LOUIS BERNARD, MD, PhD principal investigator
CHRU DE TOURS
JOUNEAU STEPHANE, MD, PhD principal investigator
Rennes University Hospital
MAILLOT FRANCOIS, MD principal investigator
CHRU DE TOURS
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisone and Hydrocortisone in people with COVID-19, run by University Hospital, Tours.
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 6 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: withdrawn, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days. (time frame: 14 days). 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 15 Jun 2026.