Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04780581
• Other study ID #: MP3-pulses-COVID-19
• Secondary ID: 2020-005026-28
• Status: Terminated
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: November 9, 2021

Study information

• 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
• Study type: Interventional

Clinical Trial Summary

Treatment with glucocorticoids in COVID patients. Low-intervention, phase IV, open-label, randomised, low-intervention clinical trial comparing 2 active treatments.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Infections

Intervention

Drug:
• Dexamethasone
6 mg/24h - 10 days
• Methylprednisolone
250 mg/ 24h - 3 days

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León	Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

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