Corona Virus Infection Clinical Trial
Official title:
MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection
Verified date | June 2022 |
Source | Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Treatment with glucocorticoids in COVID patients. Low-intervention, phase IV, open-label, randomised, low-intervention clinical trial comparing 2 active treatments.
Status | Terminated |
Enrollment | 127 |
Est. completion date | November 9, 2021 |
Est. primary completion date | November 9, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Over 18 years of age 2. Inpatient 3. Diagnosis of SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen 4. 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. 5. Requires supplementary oxygen due to basal saturation = 93% (with ambient O2, 21%) Exclusion Criteria: 1. The patient's situation is so serious that the doctor in charge thinks he could die within 24 hours. 2. At the time of randomisation, patients require one of the following 4 ventilatory supports: 1. high-flow oxygen devices. 2. non-invasive mechanical ventilation. 3. invasive mechanical ventilation. 4. Extracorporeal membrane oxygenation (ECMO). 3. 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 a4ß7 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. 4. The patient is pregnant or breastfeeding. 5. The patient has a chronic renal disease is stage 4 or 5 (CCr <30 ml/min). 6. Moderate to severe dementia at the investigator's discretion. 7. Hypersensitivity to any of the active ingredients or to any of the excipients included in its formulation. 8. Untreated systemic infections not caused by COVID-19. 9. Active stomach or duodenal ulcer. 10. Recent vaccination with live vaccines. 11. Other infection or disease that explains the lung disorder. 12. Inability of the patient to understand the study or to sign the informed consent unless consent is delegated to a legal representative. 13. Active participation in another clinical study in the last 15 days. |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Asistencial Universitario de León | León | |
Spain | Complejo Asistencial Universitario de Salamanca | Salamanca | |
Spain | Hospital Clínico Universitario de Valladolid | Valladolid | |
Spain | Hospital Universitario Río Hortega | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León | Instituto de Investigación Biomédica de Salamanca |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality rate in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial) | Mortality rate (percentage) | 28 days | |
Secondary | Admission in Intensive Unit Care (ICU) | Incidence of ICU admission | 28 days | |
Secondary | 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. |
28 days | |
Secondary | Days in hospital | Number of days in hospital from the star of the treatment until discharge | 28 days | |
Secondary | 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 |
28 days | |
Secondary | Evaluation of other immunosuppressors requirements. | Occurrence of use of other immunosuppressors (active substance, dose, duration, if applicable) | 28 days | |
Secondary | Status according to the World Health Organization (WHO) 10-category scale. | Clinical evaluation of patient status according to the WHO 10-category scale. | 3 months |
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