Corona Virus InfectionPhase 4NCT04780581
Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients
A Phase 4 study testing Dexamethasone and Methylprednisolone in people with Corona Virus Infection, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 4 sites in Spain.
Trial summary
Treatment with glucocorticoids in COVID patients. Low-intervention, phase IV, open-label, randomised, low-intervention clinical trial comparing 2 active treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- Dexamethasone and Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Feb 2021to 9 Nov 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Over 18 years of age
- Inpatient
- Diagnosis of SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen
- They present evidence in computerized axial tomography (CT) of pulmonary involvement attributed to the infection by COVID. Patients in whom CT scans are not performed must have suspected pulmonary involvement by clinical examination with simple compatible or suggestive radiology.
- Requires supplementary oxygen due to basal saturation ≤ 93% (with ambient O2, 21%)
Who cannot join
- The patient's situation is so serious that the doctor in charge thinks he could die within 24 hours.
- At the time of randomisation, patients require one of the following 4 ventilatory supports:
- high-flow oxygen devices.
- non-invasive mechanical ventilation.
- invasive mechanical ventilation.
- Extracorporeal membrane oxygenation (ECMO).
Show all 17Show fewer
- The patient is or has been treated in the 2 weeks prior to randomisation with glucocorticoids or inflammation modifying drugs, both conventional (thiopurines, cyclophosphamide, cyclosporine, tacrolimus), leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, hydroxychloroquine or chloroquine) as synthetics or biologics directed against therapeutic targets (abatacept, belimumab, CD-20, IL1, IL6, Il12. 23, IL-23, Il.17, TNF, integrin α4β7 or Janus kinase inhibitors JAK). Patients who are only on maintenance treatment with doses of steroids less than or equal to 7.5 mg of prednisone or equivalent per day will not be excluded.
- The patient is pregnant or breastfeeding.
- The patient has a chronic renal disease is stage 4 or 5 (CCr <30 ml/min).
- Moderate to severe dementia at the investigator's discretion.
- Hypersensitivity to any of the active ingredients or to any of the excipients included in its formulation.
- Untreated systemic infections not caused by COVID-19.
- Active stomach or duodenal ulcer.
- Recent vaccination with live vaccines.
- Other infection or disease that explains the lung disorder.
- Inability of the patient to understand the study or to sign the informed consent unless consent is delegated to a legal representative.
- Active participation in another clinical study in the last 15 days.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Complejo Asistencial Universitario de León
León, 24071
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Hospital Universitario Río Hortega
Valladolid, 47012
About this study
Official title: MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection
Treatment with glucocorticoids in COVID patients. Low-intervention, phase IV, open-label, randomised, low-intervention clinical trial comparing 2 active treatments.
Read the detailed description
The use of high-dose bolus glucocorticoids in the treatment of patients with COVID-19 infection will increase the anti-inflammatory effect without increasing side effects. This will allow a better patient outcome, reducing the number of deaths and the need for intubation or admission to the Intensive Care Unit.
- Conditions
- Corona Virus Infection
- Being tested
- Dexamethasone, Methylprednisolone
- 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 Recovery
6 mg/24h - 10 days
Also called Bolus
250 mg/ 24h - 3 days
| Study group | Role | What they receive |
|---|---|---|
| RECOVERY | Active comparator | intermediate-dose dexamethasone (6mg/24h - 10 days) Receives: Drug: Dexamethasone |
| BOLUS | Experimental | high-dose methylprednisolone bolus (250mg/4h - 3 days) Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
Mortality rate (percentage) in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial)
Measured: 28 days
Secondary outcomes (6)
Admission in Intensive Unit Care (ICU)
Number of patients who have been admitted to the ICU.
Measured: 28 days
Evaluation of Respiratory Support Requirements
- Proportion of patients (number of cases with respiratory support requirement / total number of patients) with non-invasive mechanical ventilation and/or high-flow oxygen requirements.
- Proportion of patients (number of cases with respiratory support requirement / total number of patients) with invasive mechanical ventilation or intubation requirements.
Measured: 28 days
Days in Hospital
Number of days in hospital from the star of the treatment until discharge
Measured: 28 days
Evaluation of Presence of Adverse Events Related With Use of High Dose of Glucocorticoids.
Occurrence of infections, hyperglycaemia, psychotic states or other adverse effects, if applicable
Measured: 28 days
Evaluation of Other Immunosuppressors Requirements.
Occurrence of use of other immunosuppressors, if applicable
Measured: 28 days
Status According to the World Health Organization (WHO) 10-category Scale.
Clinical evaluation of patient status according to the WHO 10-category scale. Minimum value: 1 and maximum value: 10, higher scores mean a worse outcome.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Feb 2021
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Why it stopped: Impossibility of reaching the sample size established by protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corona Virus 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, randomised clinical trial comparing 2 active treatments. Low-intervention clinical trial
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Sponsor
- Investigators
- Luis Corral Gudino, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780581
- Sponsor's protocol ID
- MP3-pulses-COVID-19
- Other IDs
- 2020-005026-28
- Status last verified
- Dec 2024
- First submitted
- 15 Feb 2021
- Last updated
- 6 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection
- ClinicalTrials.gov ID
- NCT04780581
- Acronym / sponsor ID
- MP3-pulses-COVID-19
- Conditions
- Corona Virus Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Impossibility of reaching the sample size established by protocol
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y LeónUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Posted 6 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment with glucocorticoids in COVID patients. Low-intervention, phase IV, open-label, randomised, low-intervention clinical trial comparing 2 active treatments.
Detailed description
The use of high-dose bolus glucocorticoids in the treatment of patients with COVID-19 infection will increase the anti-inflammatory effect without increasing side effects. This will allow a better patient outcome, reducing the number of deaths and the need for intubation or admission to the Intensive Care Unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomised clinical trial comparing 2 active treatments. Low-intervention clinical trial
| Arm | Type | Receives |
|---|---|---|
| RECOVERY | Active comparator | Drug: Dexamethasoneintermediate-dose dexamethasone (6mg/24h - 10 days) |
| BOLUS | Experimental | Drug: Methylprednisolonehigh-dose methylprednisolone bolus (250mg/4h - 3 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years of age
- Inpatient
- Diagnosis of SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen
- They present evidence in computerized axial tomography (CT) of pulmonary involvement attributed to the infection by COVID. Patients in whom CT scans are not performed must have suspected pulmonary involvement by clinical examination with simple compatible or suggestive radiology.
- Requires supplementary oxygen due to basal saturation ≤ 93% (with ambient O2, 21%)
Key exclusion criteria (17 listed)
- The patient's situation is so serious that the doctor in charge thinks he could die within 24 hours.
- At the time of randomisation, patients require one of the following 4 ventilatory supports:
- The patient is or has been treated in the 2 weeks prior to randomisation with glucocorticoids or inflammation modifying drugs, both conventional (thiopurines, cyclophosphamide, cyclosporine, tacrolimus), leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, hydroxychloroquine or chloroquine) as synthetics or biologics directed against therapeutic targets (abatacept, belimumab, CD-20, IL1, IL6, Il12. 23, IL-23, Il.17, TNF, integrin α4β7 or Janus kinase inhibitors JAK). Patients who are only on maintenance treatment with doses of steroids less than or equal to 7.5 mg of prednisone or equivalent per day will not be excluded.
- The patient is pregnant or breastfeeding.
- The patient has a chronic renal disease is stage 4 or 5 (CCr <30 ml/min).
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: Recovery6 mg/24h - 10 days | Drug | RECOVERY |
| MethylprednisoloneAlso: Bolus250 mg/ 24h - 3 days | Drug | BOLUS |
Primary outcome
Mortality Rate
Time frame: 28 days
Mortality rate (percentage) in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial)
6 secondary outcomes
Admission in Intensive Unit Care (ICU)
Time frame: 28 days
Evaluation of Respiratory Support Requirements
Time frame: 28 days
Days in Hospital
Time frame: 28 days
Evaluation of Presence of Adverse Events Related With Use of High Dose of Glucocorticoids.
Time frame: 28 days
Evaluation of Other Immunosuppressors Requirements.
Time frame: 28 days
Status According to the World Health Organization (WHO) 10-category Scale.
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Luis Corral Gudino principal investigator
Investigator
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Methylprednisolone in people with Corona Virus Infection, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 4 sites in Spain.
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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Rate (time frame: 28 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 6 Jan 2025.