Glucocorticoids in COVID-19 (CORTIVID)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-04-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid-19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Methylprednisolone Arm

Standard of care plus Methylprednisolone

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

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

Placebo Arm

Standard of care plus placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

-An infusion bag of 100 mL of 0.9% saline

Interventions

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Placebo

-An infusion bag of 100 mL of 0.9% saline

Intervention Type OTHER

Methylprednisolone

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No