Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients

NCT04780581 | Terminated Phase 4 Results

• 2 other identifiers: MP3-pulses-COVID-192020-005026-28
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Corona Virus Infection

Outcome Measures

Primary Outcomes (1)

• Mortality Rate

  Mortality rate (percentage) in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial)

  28 days

Secondary Outcomes (6)

• Admission in Intensive Unit Care (ICU)

  28 days

• Evaluation of Respiratory Support Requirements

  28 days

• Days in Hospital

  28 days

• Evaluation of Presence of Adverse Events Related With Use of High Dose of Glucocorticoids.

  28 days

• Evaluation of Other Immunosuppressors Requirements.

  28 days

Study Arms (2)

RECOVERY

ACTIVE COMPARATOR

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

Drug: Dexamethasone

BOLUS

EXPERIMENTAL

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

Drug: Methylprednisolone

Interventions

Dexamethasone DRUG

6 mg/24h - 10 days

Also known as: Recovery

RECOVERY

Methylprednisolone DRUG

250 mg/ 24h - 3 days

Also known as: Bolus

BOLUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Inpatient
• Diagnosis of SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen
• 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.
• Requires supplementary oxygen due to basal saturation ≤ 93% (with ambient O2, 21%)

You may not qualify if:

• The patient's situation is so serious that the doctor in charge thinks he could die within 24 hours.
• At the time of randomisation, patients require one of the following 4 ventilatory supports:
• high-flow oxygen devices.
• non-invasive mechanical ventilation.
• invasive mechanical ventilation.
• Extracorporeal membrane oxygenation (ECMO).
• 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.
• The patient is pregnant or breastfeeding.
• The patient has a chronic renal disease is stage 4 or 5 (CCr \<30 ml/min).
• Moderate to severe dementia at the investigator's discretion.
• Hypersensitivity to any of the active ingredients or to any of the excipients included in its formulation.
• Untreated systemic infections not caused by COVID-19.
• Active stomach or duodenal ulcer.
• Recent vaccination with live vaccines.
• Other infection or disease that explains the lung disorder.

Sponsors & Collaborators

• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator

Study Sites (4)

Complejo Asistencial Universitario de León

León, 24071, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Universitario Río Hortega

Valladolid, 47012, Spain

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Dexamethasone; Salvage Therapy; Methylprednisolone; NOP-bolus regimen

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Therapeutics; Prednisolone

Limitations and Caveats

* The sample size was not achieved due to the early termination of the study because of pandemia evolution. * The open-label design and investigator-reported data on adverse events and infections may have led to bias in the description of these events. * There was an imbalance in vaccination status between randomized groups.

Results Point of Contact

• Title: Project manager
• Organization: IBSAL

uicec.coordinacion@ibsal.es

+34 923 29 11 00

Study Officials

• Luis Corral Gudino

  Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, randomised clinical trial comparing 2 active treatments. Low-intervention clinical trial

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: March 3, 2021
• Study Start: February 1, 2021
• Primary Completion: November 9, 2021
• Study Completion: November 9, 2021
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)