Covid-19 Pneumonia
Conditions
Keywords
Covid-19, pneumonia, Inflammatory phase, Glucocorticoids
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.
Interventions
DRUGMethylprednisolone
-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión
OTHERPlacebo
-An infusion bag of 100 mL of 0.9% saline
Sponsors
Complejo Hospitalario de Navarra
Hospital Sant Joan Despí Moisès Broggi
Fundacion Miguel Servet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients developing treatment failure | At 14 days after randomization | • Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients requiring ICU admission | At 28 days after randomization | — |
| Proportion of patients requiring rescue-therapy with tocilizumab | At 14 days after randomization | — |
| Length of hospital stay | At 28 days after randomization | Time in days from randomization until the date of hospital discharge. |
| Mortality at day 28 | At 28 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 C-reactive protein (CRP) |
| Proportion of SARS-CoV-2 clearance. | At 7 days after randomization | Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum |
| 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 |
Countries
Spain
Outcome results
None listed