Glucocorticoids in COVID-19 (CORTIVID)

• Status: Completed
• Trial end date: 2021-04-09
• Target enrollment: 0
• Participant gender: All

Summary

Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Miguel Servet
• Collaborators: Complejo Hospitalario de Navarra; Hospital Sant Joan Despí Moisès Broggi
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Age ≥18 years old.

• Diagnosis of SARS-CoV-2 pneumonia confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal swab or sputum according to the recommendations of the Spanish Ministry of Health.

• Length of symptoms consistent with COVID-19 ≥7 days.

• Hospital admission.

• At least one of the following: CRP >60 mg/L, IL-6 >40 pg/mL, ferritin >1000 μg/L.

• Acceptation of informed consent

Exclusion Criteria:

• Allergy or contraindication to any of the drugs under study.

• SpO2 <90% (in air ambient) or PaO2 <60 mmHg (in ambient air) or PaO2/FiO2 <300 mmHg.

• Ongoing treatment with glucocorticoids, immunosuppressive, or biologic drugs with another indication.

• Decompensated diabetes mellitus.

• Uncontrolled hypertension.

• Psychotic or manic disorder.

• Active cancer.

• Pregnancy or lactation.

• Clinical or biochemical suspicion (procalcitonin >0.5 ng/mL) of active infection other than SARS-CoV-2.

• Out-of-hospital management patient.

• Conservative or palliative management patient.

• Participation in another clinical trial.

• Any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.