Adult patients with SARS-CoV-2 infection (COVID19) requiring hospital admission for pneumonia. Who present pcr = 66 mg/L and =150 mg/L at inclusion or Pandemic score [13] on admission > 200 with pcr 9.7-149 mg/L at inclusion. WHO scale level 4 [14], with need for oxygen therapy in NG = 1 lpm to maintain saturation = 94%.
Conditions
Interventions
Trade Name: Dexamethasone 20 mg
Product Name: Dexamethasone
Product Code: SUB07017MIG
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2
Curren
Sponsors
Fundación para la Investigación e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor y Hospital Unive
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients admitted with SARS-CoV-2 pneumonia (COVID19) confirmed by antigenic test or PCR Age = 18 years. presents with a pcr = 66 mg/L and =150 mg/L at inclusion or Pandemic score [13] at admission > 200 with pcr 9.7-149 mg/L at inclusion WHO scale level 4 [14], with need for oxygen therapy in NG = 1 lpm to maintain saturation = 94%. Onset of symptoms = 10 days before the date of inclusion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Patients with criteria of respiratory distress at the time of randomisation, understood as need for OCNAF/NIMV/MIV (levels 5 and 6 of the WHO scale) or O2 saturation = 92% and/or RF = 30 despite oxygen in NG at 4 litres. Patients with allergy or contraindication to the use of systemic corticosteroids. Patients with severe asthma or chronic lung disease with home oxygen requirements and active corticosteroid therapy. Patients on chronic corticosteroid therapy Use of corticosteroids daily in the 15 days prior to hospital admission. Indication for steroid use due to other clinical conditions of the patient (e.g. septic shock) Pregnant or actively breastfeeding women Patients with suspected or confirmed bacterial, fungal, or viral infection other than SARS-CoV-2 itself at time of randomisation Patients with confirmed past or latent tuberculosis infection prior to inclusion. Patients with known HIV infection with CD4 below 500 cells/mm3 or on active treatment with protease inhibitors or boosters such as cobicistat or ritonavir. Patients with active oncological processes in the last year or on active treatment with chemotherapy. Patients with life expectancy < 3 months at inclusion due to clinical conditions other than SARS-CoV-2 pneumonia. Patients expected to die within 48-72 hours. Patients included in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether there is a decrease in the proportion of patients who develop respiratory distress requiring NIV/MIV/OCNAF (measured group and individually by respiratory therapies). To assess whether there is an impact of such a strategy on the number of days of hospitalization. ;Secondary Objective: To evaluate whether there is a decrease in NIV/MIV/OCNAF therapy days. Evaluate whether there is a decrease in 30-, 60-, and 90-day, all-cause mortality. Safety: related short- and long-term adverse events. ;Primary end point(s): Requirement of respiratory therapy with NIV/MIV/OCNAF Need for respiratory support with NIMV/MIV/OCNAF Days of hospitalization counted from signature of informed consent to time of discharge from hospital ;Timepoint(s) of evaluation of this end point: 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Days of respiratory therapy with NIV/MIV/OCNAF (counted individually and grouped in case they were sequential and consecutive). Mortality during admission and at 30, 60 and 90 days, from all causes.;Timepoint(s) of evaluation of this end point: 100 days | — |
Countries
Spain
Contacts
Public ContactÁngel Pueyo
Fundación para la Investigación e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor
Outcome results
None listed