Back to resultsGlucocorticoid Therapy in Coronavirus Disease COVID-19 Patients
Primary Purpose
Corona Virus Infection
Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Dexamethasone
Methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Corona Virus Infection
Eligibility Criteria
Inclusion Criteria:
- 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%)
Exclusion Criteria:
- 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).
- 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.
Sites / Locations
- Complejo Asistencial Universitario de León
- Complejo Asistencial Universitario de Salamanca
- Hospital Clínico Universitario de Valladolid
- Hospital Universitario Río Hortega
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
RECOVERY
BOLUS
Arm Description
intermediate-dose dexamethasone (6mg/24h - 10 days)
high-dose methylprednisolone bolus (250mg/4h - 3 days)
Outcomes
Primary Outcome Measures
Mortality rate in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial)
Mortality rate (percentage)
Secondary Outcome Measures
Admission in Intensive Unit Care (ICU)
Incidence of ICU admission
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.
Days in hospital
Number of days in hospital from the star of the treatment until discharge
Evaluation of presence of adverse events related with use of high dose of glucocorticoids.
Presence or absence of adverse effects (infections, hyperglycaemia, psychotic states or other adverse effects).
Incidence of infections, hyperglycaemia, psychotic states or other adverse effects, if applicable
Evaluation of other immunosuppressors requirements.
Occurrence of use of other immunosuppressors (active substance, dose, duration, if applicable)
Status according to the World Health Organization (WHO) 10-category scale.
Clinical evaluation of patient status according to the WHO 10-category scale.
Full Information
NCT ID
NCT04780581
First Posted
February 15, 2021
Last Updated
June 10, 2022
Sponsor
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Collaborators
Instituto de Investigación Biomédica de Salamanca
1. Study Identification
Unique Protocol Identification Number
NCT04780581
Brief Title
Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients
Official Title
MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Impossibility of reaching the sample size established by protocol
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
November 9, 2021 (Actual)
Study Completion Date
November 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Collaborators
Instituto de Investigación Biomédica de Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Open-label, randomised clinical trial comparing 2 active treatments. Low-intervention clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RECOVERY
Arm Type
Active Comparator
Arm Description
intermediate-dose dexamethasone (6mg/24h - 10 days)
Arm Title
BOLUS
Arm Type
Experimental
Arm Description
high-dose methylprednisolone bolus (250mg/4h - 3 days)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Recovery
Intervention Description
6 mg/24h - 10 days
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Bolus
Intervention Description
250 mg/ 24h - 3 days
Primary Outcome Measure Information:
Title
Mortality rate in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial)
Description
Mortality rate (percentage)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Admission in Intensive Unit Care (ICU)
Description
Incidence of ICU admission
Time Frame
28 days
Title
Evaluation of respiratory support requirements
Description
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.
Time Frame
28 days
Title
Days in hospital
Description
Number of days in hospital from the star of the treatment until discharge
Time Frame
28 days
Title
Evaluation of presence of adverse events related with use of high dose of glucocorticoids.
Description
Presence or absence of adverse effects (infections, hyperglycaemia, psychotic states or other adverse effects).
Incidence of infections, hyperglycaemia, psychotic states or other adverse effects, if applicable
Time Frame
28 days
Title
Evaluation of other immunosuppressors requirements.
Description
Occurrence of use of other immunosuppressors (active substance, dose, duration, if applicable)
Time Frame
28 days
Title
Status according to the World Health Organization (WHO) 10-category scale.
Description
Clinical evaluation of patient status according to the WHO 10-category scale.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%)
Exclusion Criteria:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Corral Gudino
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Asistencial Universitario de León
City
León
ZIP/Postal Code
24071
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Hospital Universitario Río Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients
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