Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Status and phase: Terminated; Phase 4

Conditions: Corona Virus Infection

Treatments: Drug: Dexamethasone; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT04780581

2020-005026-28 (EudraCT Number)

MP3-pulses-COVID-19

Details and patient eligibility

About

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

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

RECOVERY

Active Comparator group

Description:

intermediate-dose dexamethasone (6mg/24h - 10 days)

Treatment:

Drug: Dexamethasone

BOLUS

Experimental group

Description:

high-dose methylprednisolone bolus (250mg/4h - 3 days)

Treatment:

Drug: Methylprednisolone