Trial | NCT04438980  Report issue

Title

Glucocorticoids in COVID-19 (CORTIVID)
Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    72
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.
Study Started
May 15
2020
Primary Completion
Mar 12
2021
Study Completion
Apr 09
2021
Last Update
May 17
2021

Drug Methylprednisolone

-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión

Other Placebo

-An infusion bag of 100 mL of 0.9% saline

Methylprednisolone Arm Experimental

Standard of care plus Methylprednisolone

Placebo Arm Placebo Comparator

Standard of care plus placebo

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.
No Results Posted