Clinical trial NCT04780581: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Corona Virus Infection
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
First posted: 2021-03-03
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, randomised clinical trial comparing 2 active treatments. Low-intervention clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 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.
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.

Primary outcomes:
measure: Mortality Rate
timeFrame: 28 days
Secondary outcomes:
measure: Admission in Intensive Unit Care (ICU)
timeFrame: 28 days
measure: Evaluation of Respiratory Support Requirements
timeFrame: 28 days
measure: Days in Hospital
timeFrame: 28 days
measure: Evaluation of Presence of Adverse Events Related With Use of High Dose of Glucocorticoids.
timeFrame: 28 days
measure: Evaluation of Other Immunosuppressors Requirements.
timeFrame: 28 days
measure: Status According to the World Health Organization (WHO) 10-category Scale.
timeFrame: 90 days
Other outcomes:
Locations:
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
Study officials:
affiliation: Investigator
name: Luis Corral Gudino
role: PRINCIPAL_INVESTIGATOR
References: