Glucocorticoids in COVID-19 (CORTIVID)

Fundacion Miguel Servet

Status and phase

Completed

Phase 3

Conditions

Covid-19 Pneumonia

Treatments

Drug: Methylprednisolone

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04438980

CORTIVID

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.