Glucocorticoids in COVID-19 (CORTIVID)
- Registration Number
- NCT04438980
- Lead Sponsor
- Fundacion Miguel Servet
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Arm Placebo Standard of care plus placebo Methylprednisolone Arm Methylprednisolone Standard of care plus Methylprednisolone
- Primary Outcome Measures
Name Time Method Proportion of patients developing treatment failure At 14 days after randomization • Decrease in SpO2 \<90% (in ambient air) or PaO2 \<60 mmHg (in ambient air) or PaO2FiO2 \<300 mmHg, associated with radiological impairment
- Secondary Outcome Measures
Name Time Method Proportion of patients requiring rescue-therapy with tocilizumab At 14 days after randomization Proportion of bacterial, fungal or opportunistic infections At 28 days after randomization Evolution of inflammatory biomarkers related to COVID-19 At 14 days after randomization Change in plasma levels of D-dimer (DD)
Mortality at day 28 At 28 days after randomization Proportion of patients requiring ICU admission At 28 days after randomization Length of hospital stay At 28 days after randomization Time in days from randomization until the date of hospital discharge.
Proportion of severe adverse events At 28 days after randomization Any undesirable experience related to the use of the studied drugs, which causes patient's death, life-threatening risk, hospitalization or extension of a previous hospitalization, disability or permanent damage, requires intervention to prevent permanent impairment or damage, or is considered medically relevant
Proportion of SARS-CoV-2 clearance. At 7 days after randomization Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum
Trial Locations
- Locations (2)
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Sant Joan Despí Moisès Broggi
🇪🇸Sant Joan Despí, Barcelona, Spain