meta|Evidence - COVID-19
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dexamethasone (n=2104) vs. standard of care (n=4321)
randomized controlled trial some concerns about risk of bias
Dexamethasone
Oral or intravenous dexamethasone at a dose of 6 mg once daily for up to 10 days (or until hospital discharge if sooner) plus standard of care.
Standard of care
Standard of care alone.
COVID 19 hospitalized
Hospitalized patients were eligible for the trial if they had clinically suspected or laboratoryconfirmed SARS-CoV-2 infection and no medical history that might, in the opinion of the attendingclinician, put patients at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020. Pregnant or breast-feeding women were eligible.
Open-label.
175 NHS hospitals in UK
preliminary results
dexamethasone (n=7) vs. standard of care (n=12)
randomized controlled trial low risk of bias
Dexamethasone
Dexamethasone 20 mg/iv/daily/from day 1 of randomization during 5 days, followed by 10 mg/iv/daily from day 6 to 10, plus standard of care.
Standard of care
Standard intensive care.
COVID-19 severe or critically
Age ≥ 18 years, positive reverse-transcriptase polymerase-chain-reaction (RT-PCR) assay for SARS-CoV-2 in a respiratory tract sample, intubated and mechanically ventilated, acute onset of moderate-to-severe ARDS, as defined by Berlin criteria, which includes (i) having pneumonia, (ii) bilateralpulmonary infiltrates on chest imaging (x-ray or CTscan), (iii) absence of left atrial hypertension or no clinicalsigns of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ratio of ≤ 200 mmHg on positive end-expiratory pressure (PEEP) of ≥ 5 cmH2O, regardless of FiO2.
Open-label
Multicenter, ICUs in teaching hospitals, Spain.
Study not published yet. Data and results come from Sterne J et al. meta-analysis, trial protocol and statistical plan. Planned sample size: 200 patients.
dexamethasone (n=151) vs. standard of care (n=148)
randomized controlled trial some concerns about risk of bias
Dexamethasone
Dexamethasone 20mg intravenously once daily for 5 days, followed by 10 mg intravenously once daily for additional 5 days or until ICU discharge, whichever occurred first, plus standard care.
Standard care
Standard care alone.
Standard care in both groups. All clinical interventions, such as use of antibiotics, ventilatory strategy, laboratory testing, and hemodynamic management were left at thediscretion of the ICU team for both groups.
COVID-19 severe or critically
Patients age ≥18 years old, with probable or confirmed infection by SARS-CoV2, intubated and mechanically ventilated, moderate or severe ARDS according to Berlin criteria (partial pressure of arterial blood oxygen to fraction of inspired oxygen (PaO2:FIO2) ratio of 200 or less.), onset of moderate or severe ARDS in less than 48h before randomization.
Open-label.
Multicenter, 41 intensive care units (ICUs) in Brazil.
The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients
dexamethasone (n=25) vs. standard of care (n=25)
randomized controlled trial some concerns about risk of bias
Dexamethasone
intravenous dexamethasone at a dose of 20 mg/day from day 1–5 and then at 10 mg/day from day 6–10.
Control
No corticosteroids
Patients in both groups received oxygen support (CPAP with pressure of 5–10 cmH2O and FIO2 equal to 60 to achieve SPO2≥90% and the duration was different ac-cording to the monitoring of patients’ clinical status), fluid support, and lopinavir/ritonavir (200/50 mg, two tablets twice a day) according to the National Iranian Guidelines
COVID-19 severe or critically
(1) age >18 years; (2) SARS-CoV-2 infection confirmed by a reverse transcription-polymerase chain reac-tion test; (3) ratio of partial pressure of oxygen in arterial blood to fraction of inspired oxygen (PaO2/FiO2) between 100 and 300 mmHg; (4) bilateral lung infiltration; and (5) provision of written informed consent by the patient.
Open-label.
Single center, Dr. Masih Daneshvari Hospital, Tehran, Iran.
dexamethasone (n=75) vs. tocilizumab (n=74)
randomized controlled trial high risk of bias
Dexamethasone
Standard of care plus pulse dexamethasone 4 mg/kg/day in an infusion form for 3 days, followed by a maintenance dose of 8 mg/day for ten days.
Tocilizumab
Standard of care plus tocilizumab 4 mg/kg/dose in 100 cc normal saline over one hour repeated afer 24 h, then patient continue symptomatic treatment and oxygen therapy and/or assisted ventilation as needed.
All patients received standard of care.
COVID-19 severe or critically
Patients with signifcant deterioration in respiratory clinical status with respiratory rate>30 cycle/minute, Bilateral ChestmL) computed tomography (CT) infltration>30%, PaO2/FiO2 ratio<150 or saturation<90 on>6 L/min, Two positive laboratory tests of the following: (CRP>10 g/L, lymphocytes<600/mm3, D-dimer>500 ng/mL , ferritin>500 ng/mL). Patients who were not requiring supplemental oxygen were excluded from the study.
Open-label.
ICU of ESNA hospital, Egypt.
Dexamethasone 12mg (n=497) vs. dexamethasone 6mg (n=485)
randomized controlled trial low risk of bias
Dexamethasone 12mg
Standard of care plus intravenous bolus injection of dexamethasone 12 mg once daily for up to 10 days.
Dexamethasone 6mg
Standard of care plus intravenous bolus injection of dexamethasone 6 mg once daily for up to 10 days.
Betamethasone (12mg or 6mg) use was allowed at sites where dexamethasone was not available.
COVID-19 severe or critically
Aged 18 years or above AND confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation AND use of one of the following: Invasive mechanical ventilation OR Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system.
Double-blind.
Multicenter: 26 hospitals in Europe (Denmark, Sweden, Switzerland) and India.
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