Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia (NCT04359511) | Clinical Trial Compass
WithdrawnPhase 3
Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia
Stopped: COMPETITOR TEST (RECOVERY)
0Started 2020-07-03
Plain-language 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). 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days.