Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients

Phase 4

Terminated

• Conditions: Corona Virus Infection
• Interventions: Drug: Dexamethasone; Drug: Methylprednisolone

• Registration Number: NCT04780581
• Lead Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-03
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09
• Results First Submitted: 2022-11-21
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Results First Posted: 2025-01-06
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RECOVERY	Dexamethasone	intermediate-dose dexamethasone (6mg/24h - 10 days)
BOLUS	Methylprednisolone	high-dose methylprednisolone bolus (250mg/4h - 3 days)

Primary Outcome Measures

Name	Time	Method
Mortality Rate	28 days	Mortality rate (percentage) in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial)

Secondary Outcome Measures

Name	Time	Method
Admission in Intensive Unit Care (ICU)	28 days	Number of patients who have been admitted to the ICU.
Evaluation of Respiratory Support Requirements	28 days	* 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	28 days	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.	28 days	Occurrence of infections, hyperglycaemia, psychotic states or other adverse effects, if applicable
Evaluation of Other Immunosuppressors Requirements.	28 days	Occurrence of use of other immunosuppressors, if applicable
Status According to the World Health Organization (WHO) 10-category Scale.	90 days	Clinical evaluation of patient status according to the WHO 10-category scale. Minimum value: 1 and maximum value: 10, higher scores mean a worse outcome.

Trial Locations

Locations (4)

Complejo Asistencial Universitario de León; 🇪🇸 León, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Complejo Asistencial Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario Río Hortega; 🇪🇸 Valladolid, Spain