Table 5a. Systemic Corticosteroids: Selected Clinical Data

Last Updated: January 26, 2023

The clinical trials described in this table do not represent all the trials that the Panel reviewed while developing the recommendations for systemic corticosteroids. The studies summarized below are those that have had the greatest impact on the Panel’s recommendations. Unless stated otherwise, the clinical trials listed below only included participants aged ≥18 years.

Table 5a. Systemic Corticosteroids: Selected Clinical Data
Methods	Results	Limitations and Interpretation
RECOVERY: Open-Label RCT of Dexamethasone in Hospitalized Patients With COVID-19 in the United Kingdom¹
Key Inclusion Criterion Hospitalized with suspected or laboratory-confirmed SARS-CoV-2 infection Key Exclusion Criteria Physician determination that risks of participation were too great based on patient’s medical history An indication for corticosteroid therapy outside of the study Interventions DEX 6 mg IV or PO once daily plus SOC for up to 10 days or until discharge (n = 2,104) SOC alone (n = 4,321) Primary Endpoint All-cause mortality at 28 days	Participant Characteristics Mean age 66 years; 64% men; 73% White 56% had ≥1 comorbidity; 24% with DM 89% had laboratory-confirmed SARS-CoV-2 infection Median of 7 days of DEX therapy At randomization: 16% received MV or ECMO 60% required supplemental oxygen but not MV 24% required no supplemental oxygen Received RDV: <1% in both arms Received tocilizumab or sarilumab: 2% in DEX arm vs. 3% in SOC arm Primary Outcome All-cause mortality at 28 days in DEX arm vs. SOC arm: All patients: 23% vs. 26% (age-adjusted rate ratio 0.83; 95% CI, 0.75–0.93; P < 0.001) Patients who required MV or ECMO at randomization: 29% vs. 41% (rate ratio 0.64; 95% CI, 0.51–0.81) Patients who required supplemental oxygen but not MV at randomization: 23% vs. 26% (rate ratio 0.82; 95% CI, 0.72–0.94) Patients who did not require supplemental oxygen at randomization: 18% vs. 14% (rate ratio 1.19, 95% CI, 0.92–1.55)	Key Limitations Open-label study Published data did not include results for key secondary endpoints (e.g., cause-specific mortality, need for renal replacement), AEs, and key subgroups (e.g., patients with comorbidities). Patients who required supplemental oxygen (but not MV) had variable severity of illness. It is unclear whether all patients in this group benefited from DEX or whether benefit is restricted to those requiring higher levels of supplemental oxygen. Patients aged >80 years were preferentially assigned to receive supplemental oxygen therapy (and not MV). High mortality in this study may limit the generalizability of results to populations with a lower baseline mortality. Interpretation In hospitalized patients with severe COVID-19 who required supplemental oxygen, DEX reduced mortality at 28 days. The greatest benefit was seen in those receiving MV at randomization. There was no survival benefit for DEX in patients who did not require supplemental oxygen at randomization.
CoDEX: Open-Label RCT of Dexamethasone in Patients With Moderate or Severe ARDS and COVID-19 in Brazil²
Key Inclusion Criteria Confirmed or suspected SARS-CoV-2 infection Received MV within 48 hours of meeting criteria for moderate to severe ARDS (PaO₂/FiO₂ ≤200 mm Hg) Key Exclusion Criteria Received immunosuppressive drugs in past 21 days Death expected within 24 hours Interventions DEX 20 mg IV once daily for 5 days, then DEX 10 mg IV once daily for 5 days or until ICU discharge (n = 151) SOC alone (n = 148) Primary Endpoint Number of days alive and free from MV by Day 28 Key Secondary Endpoints All-cause mortality by Day 28 Number of ICU-free days by Day 28 Duration of MV by Day 28 Score on 6-point OS at Day 15 SOFA score at Day 7	Participant Characteristics Mean age 61 years; 63% men Comorbidities in DEX arm vs. SOC arm: Obesity: 31% vs. 24% DM: 38% vs. 47% Vasopressor use: 66% in DEX arm vs. 68% in SOC arm Mean PaO₂/FiO₂: 131 mm Hg in DEX arm vs. 133 mm Hg in SOC arm Median of 10 days of DEX therapy No patients received RDV or tocilizumab 35% in SOC arm received corticosteroids for indications such as bronchospasm or septic shock Primary Outcome Mean number of days alive and free from MV by Day 28: 7 in DEX arm vs. 4 in SOC arm (P = 0.04) Secondary Outcomes No differences between arms in all-cause mortality (56% in DEX arm vs. 62% in SOC arm), number of ICU-free days, duration of MV, or score on 6-point OS Mean SOFA score at Day 7: 6.1 in DEX arm vs. 7.5 in SOC arm (P = 0.004) Other Outcome Post hoc analysis of probability of death or MV by Day 15: 68% in DEX arm vs. 80% in SOC arm (OR 0.46)	Key Limitations Open-label study Underpowered; enrollment stopped after release of data from the RECOVERY trial. Patients discharged before 28 days were not followed for rehospitalization or mortality. High mortality in this study may limit the generalizability of results to populations with a lower baseline mortality. More than one-third of those randomized to receive SOC also received corticosteroids. Interpretation Compared with SOC alone, DEX increased the number of days alive and free of MV over 28 days in patients with COVID-19 and moderate to severe ARDS.
Observational Cohort Study of Dexamethasone in Hospitalized Patients With COVID-19 Who Were Not on Intensive Respiratory Support in the United States³
Key Inclusion Criterion Within 14 days of a positive test result for SARS-CoV-2 infection Key Exclusion Criteria Recent receipt of corticosteroids Receipt of IRS (defined as HFNC oxygen, NIV, or MV) within 48 hours Hospital LOS of <48 hours Interventions Corticosteroids (95% of patients received DEX) administered within 48 hours of admission (n = 7,507) No corticosteroids administered (n = 7,433) Primary Endpoint All-cause mortality at 90 days	Participant Characteristics Mean age 71 years; 95% men; 27% Black, 55% White 77% did not receive IRS within 48 hours 83% admitted within 1 day after positive SARS-CoV-2 test result Median duration of DEX for patients who did not receive IRS: 5 days for patients who were not on supplemental oxygen at baseline vs. 6 days for patients on low-flow nasal cannula oxygen Received RDV: 43% of those who received DEX vs. 13% of those who did not Received anticoagulants: 46% of those who received DEX vs. 10% of those who did not Primary Outcome Risk of all-cause mortality at 90 days was higher in those who received DEX: For combination of those not on supplemental oxygen and those on low-flow nasal cannula oxygen: HR 1.59; 95% CI, 1.39–1.81 For those not on supplemental oxygen: HR 1.76; 95% CI, 1.47–2.12 For those on low-flow nasal cannula oxygen: HR 1.08; 95% CI, 0.86–1.36	Key Limitations Retrospective observational study Because nearly all patients on MV or HFNC oxygen received DEX, analysis was restricted to patients who did not receive IRS (i.e., those who received no supplemental oxygen or only low-flow nasal cannula oxygen). There were differences between the arms in other therapies received. The investigators attempted to account for this using different approaches (e.g., propensity scoring, weighted analyses, subgroup/sensitivity analyses). Interpretation In hospitalized patients with COVID-19, the use of DEX was not associated with a reduction in mortality among those who received low-flow nasal cannula oxygen during the first 48 hours after admission, but it was associated with increased mortality among those who received no supplemental oxygen during the first 48 hours after admission.
COVID STEROID 2: Blinded RCT of Dexamethasone 12 mg Versus 6 mg in Hospitalized Adults With COVID-19 and Severe Hypoxemia in Denmark, India, Sweden, and Switzerland^4,5
Key Inclusion Criteria Confirmed SARS-CoV-2 infection Requiring oxygen ≥10 L/min, NIV, CPAP, or MV Key Exclusion Criteria Treated with DEX >6 mg (or equivalent) Treated with a corticosteroid within past 5 days Invasive fungal infection or active TB Interventions DEX 12 mg IV once daily for up to 10 days (n = 497) DEX 6 mg IV once daily for up to 10 days (n = 485) Primary Endpoint Number of days alive without life support (MV, circulatory support, or kidney replacement therapy) at 28 days Key Secondary Endpoints Number of days alive without life support at 90 days Number of days alive and out of hospital at 90 days Mortality at 90 days Mortality at 28 days SAEs at 28 days	Participant Characteristics Median age 65 years; 31% women DM: 27% in 12 mg arm vs. 34% in 6 mg arm Median of 7 days from symptom onset to hospitalization in both arms Received ICU care: 78% in 12 mg arm vs. 81% in 6 mg arm Oxygen requirements: 54% on oxygen via nasal cannula or face mask (median flow rate 23 L/min) 25% on NIV 21% on MV 63% received RDV; 12% received IL-6 inhibitors or JAK inhibitors Median of 7 days of DEX therapy in both arms Primary Outcome Median number of days alive without life support at 28 days: 22.0 in 12 mg arm vs. 20.5 in 6 mg arm (adjusted mean difference 1.3 days; 95% CI, 0.0–2.6; P = 0.07) 63.9% Bayesian probability of clinically important benefit and 0.3% Bayesian probability of clinically important harm for DEX 12 mg Secondary Outcomes At 90 days: Median number of days alive without life support: 84 in 12 mg arm vs. 80 in 6 mg arm (P = 0.15) Median number of days alive and out of hospital: 62 in 12 mg arm vs. 48 in 6 mg arm (P = 0.09) Mortality: 32% in 12 mg arm vs. 38% in 6 mg arm (adjusted relative risk 0.87; 99% CI, 0.70–1.07; P = 0.09) At 28 days: Mortality: 27% in 12 mg arm vs. 32% in 6 mg arm (adjusted relative risk 0.86; 99% CI, 0.68–1.08; P = 0.10) SAEs, including septic shock and invasive fungal infections: 11% in 12 mg arm vs. 13% in 6 mg arm (adjusted relative risk 0.83; 99% CI, 0.54–1.29; P = 0.27)	Key Limitation The randomized intervention period was <10 days in some patients because the trial allowed up to 4 days of DEX before enrollment. Interpretation Among patients with COVID-19 and severe hypoxemia, the use of DEX 12 mg once daily did not result in more days alive without life support at 28 days than DEX 6 mg once daily.
CAPE COVID: Double-Blind RCT of Hydrocortisone Among Critically Ill Patients With COVID-19 in France⁶
Key Inclusion Criteria Laboratory-confirmed SARS-CoV-2 infection or radiographically suspected COVID-19 with ≥1 of the following: MV with PEEP ≥5 cm H₂O PaO₂/FiO₂ <300 mm Hg and FiO₂ ≥50% on HFNC PaO₂/FiO₂ <300 mm Hg on reservoir mask oxygen Pulmonary severity index score >130 Key Exclusion Criteria Septic shock Do-not-intubate orders Interventions Continuous IV infusion of hydrocortisone 200 mg per day for 7 days, then 100 mg per day for 4 days, then 50 mg per day for 3 days. If patient improved by Day 4, then IV infusion of hydrocortisone 200 mg per day for 4 days, then 100 mg per day for 2 days, then 50 mg per day for 2 days (n = 76). Placebo (n = 73) Primary Endpoint Treatment failure (death or dependency on MV or high-flow oxygen) by Day 21 Key Secondary Endpoints Need for intubation, prone positioning, ECMO, or inhaled nitric oxide Nosocomial infection by Day 28 Clinical status on Day 21, as measured by a 5-item scale: Death In ICU and on MV Required high-flow oxygen therapy Required low-flow oxygen therapy Discharged from ICU	Participant Characteristics Mean age 62 years; 70% men; median BMI 28 96% had laboratory-confirmed SARS-CoV-2 infection Median symptom duration of 9–10 days 81% required MV at baseline Received vasopressors: 24% in hydrocortisone arm vs. 18% in placebo arm <5% received RDV or tocilizumab Median duration of treatment with study drug: 11 days in hydrocortisone arm vs. 13 days in placebo arm (P = 0.25) Primary Outcome Treatment failure by Day 21: 42% in hydrocortisone arm vs. 51% in placebo arm (P = 0.29) Secondary Outcomes No difference between arms in need for intubation or prone positioning (too few patients received ECMO or inhaled nitric oxide for comparisons) Among patients who did not require MV at baseline, 50% in hydrocortisone arm vs. 75% in placebo arm required subsequent intubation No difference between arms in proportion of patients with nosocomial infection by Day 28 No difference between arms in clinical status on Day 21, but 15% died in hydrocortisone arm vs. 27% in placebo arm (P = 0.06) Discharged from ICU by Day 21: 57% in hydrocortisone arm vs. 44% in placebo arm; 23% in both arms still required MV	Key Limitations Underpowered; enrollment stopped after release of data from the RECOVERY trial, resulting in limited power to detect differences between arms. Limited information about comorbidities Interpretation The use of hydrocortisone did not reduce the proportion of patients with COVID-19 and acute respiratory failure who experienced treatment failure by Day 21.
REMAP-CAP: Randomized, Open-Label, Adaptive Trial of Hydrocortisone in Patients With Severe COVID-19⁷
Key Inclusion Criteria Presumed or laboratory-confirmed SARS-CoV-2 infection ICU admission for respiratory or cardiovascular support Key Exclusion Criteria Presumed imminent death Systemic corticosteroid use >36 hours since ICU admission Interventions Hydrocortisone 50 mg IV every 6 hours for 7 days (n = 137) Shock-dependent hydrocortisone 50 mg IV every 6 hours for duration of shock for up to 28 days (n = 146) No hydrocortisone (n = 101) Primary Endpoint Number of days free from respiratory and cardiovascular support by Day 21 Key Secondary Endpoint In-hospital mortality	Participant Characteristics Mean age 60 years; 71% men; 53% White Mean BMI range of 29.7–30.9 for the 3 arms 50% to 64% required MV Primary Outcome No difference between arms in median number of organ support-free days at Day 21 (0 in each arm) Median adjusted ORs for primary outcome for hydrocortisone arms compared to no hydrocortisone arm: OR 1.43 (95% CrI, 0.91–2.27) with 93% Bayesian probability of superiority for fixed-dose hydrocortisone arm OR 1.22 (95% CrI, 0.76–1.94) with 80% Bayesian probability of superiority for shock-dependent hydrocortisone arm Key Secondary Outcome No difference between arms in in-hospital mortality (30% in fixed-dose hydrocortisone arm vs. 26% in shock-dependent hydrocortisone arm vs. 33% in no hydrocortisone arm)	Key Limitations Open-label study Enrollment stopped after release of data from the RECOVERY trial. Interpretation The use of hydrocortisone did not increase the median number of organ support-free days in either the fixed-dose or the shock-dependent hydrocortisone arms, although early termination limited the study’s power to detect differences between the study arms.
Single-Blind RCT of Methylprednisolone in Hospitalized Patients With COVID-19 Pneumonia in China⁸
Key Inclusion Criteria Laboratory-confirmed SARS-CoV-2 infection Pneumonia confirmed by chest CT scan Hospitalized on general ward for <72 hours Key Exclusion Criteria Severe immunosuppression Corticosteroid use for other diseases Interventions Methylprednisolone 1 mg/kg per day IV for 7 days (n = 43) Saline (n = 43) Primary Endpoint Clinical deterioration at 14 days Key Secondary Endpoints Clinical cure at 14 days Time to clinical cure ICU admission In-hospital mortality Number of days hospitalized	Participant Characteristics Mean age 56 years; 48% men Median of 8 days from symptom onset to randomization At randomization, 71% were receiving oxygen via nasal cannula Primary Outcome Clinical deterioration at 14 days: 4.8% in both arms (OR 1.0; 95% CI, 0.134–7.442; P = 1.00) Secondary Outcomes No differences (all P > 0.05) between methylprednisolone arm and placebo arm for: Clinical cure at 14 days: 51% vs. 58% Median number of days to clinical cure: 14 vs. 12 ICU admission: 4.8% in both arms In-hospital mortality: 0% vs. 2.3% Median number of days hospitalized: 17 vs. 13	Key Limitations Small sample size Terminated early because of decreasing incidence of COVID-19 pneumonia at study sites Interpretation The incidence of clinical deterioration did not differ between the methylprednisolone and placebo arms.
Single-Blind RCT of 3 Doses of Dexamethasone in Hospitalized Patients With Moderate to Severe COVID-19 in Iran⁹
Key Inclusion Criteria PCR-confirmed SARS-CoV-2 infection or CT scan showing lung involvement Moderate or severe COVID-19 Requirement for supplemental oxygen Key Exclusion Criteria Uncontrolled DM Active fungal or parasitic infection On MV or receiving vasopressor therapy Interventions Low dose: DEX 8 mg IV once daily for up to 10 days (n = 47) Intermediate dose: DEX 8 mg IV twice daily for up to 10 days (n = 40) High dose: DEX 8 mg IV 3 times a day for up to 10 days (n = 46) Primary Endpoint Time to clinical response, as measured by an OS Key Secondary Endpoints Mortality at 60 days Occurrence of AEs	Participant Characteristics Mean age: 59 years in low-dose arm vs. 59 years in intermediate-dose arm vs. 56 years in high-dose arm 50% men 23% with DM 75% received RDV Primary Outcome Mean number of days to clinical response: 4.3 in low-dose arm vs. 5.3 in intermediate-dose arm vs. 6.1 in high-dose arm (P = 0.025) Secondary Outcomes Mortality at 60 days: 17% in low-dose arm vs. 30% in intermediate-dose arm vs. 41% in high-dose arm (P = 0.06) AEs (leukocytosis, hyperglycemia, and secondary infections) occurred more frequently in intermediate-dose and high-dose arms than in low-dose arm; however, this result was not statistically significant.	Key Limitation Small sample size Interpretation The time to clinical response was significantly shorter in the low-dose DEX arm than in the intermediate- or high-dose arms. Patients in the low-dose arm had a higher probability of survival than those in the high-dose arm.
Open-Label Randomized Trial of High-Dose Versus Low-Dose Dexamethasone in Patients With COVID-19–Related ARDS in Argentina¹⁰
Key Inclusion Criteria Laboratory-confirmed SARS-CoV-2 infection ARDS On MV for <72 hours Key Exclusion Criteria Presumed imminent death Immunosuppression Treatment with glucocorticoids Interventions High dose: DEX 16 mg IV once daily for 5 days, then DEX 8 mg IV once daily for 5 days (n = 49) Low dose: DEX 6 mg IV once daily for 10 days (n = 49) Primary Endpoints Number of ventilator-free days by Day 28 Time to discontinuation of MV Key Secondary Endpoint All-cause mortality by Day 28 and Day 90	Participant Characteristics Mean age: 60 years in high-dose arm vs. 63 years in low-dose arm 30% women Primary Outcomes Median number of ventilator-free days by Day 28: 0 for both arms (P = 0.23) No difference between arms in mean duration of MV by Day 28 (19 ±18 days in high-dose arm vs. 25 ±22 days in low-dose arm; P = 0.078). Cumulative hazard of successful discontinuation from MV was greater in high-dose arm than in low-dose arm (adjusted subdistribution HR 1.84; 95% CI, 1.31–2.5; P < 0.001). Secondary Outcome All-cause mortality: By Day 28: 41% in high-dose arm vs. 39% in low-dose arm (P > 0.999) By Day 90: 47% in both arms (P > 0.999)	Key Limitations Small, open-label study Trial was prematurely terminated due to low enrollment rate. Interpretation The use of a higher dose of DEX did not increase the median number of ventilator-free days in patients with ARDS due to COVID-19. However, the higher dose shortened the time to discontinuation of MV.
COVIDICUS: RCT of High-Dose Dexamethasone Versus Standard of Care Dexamethasone in Patients With COVID-19–Related Respiratory Failure in the ICU in France¹¹
Key Inclusion Criteria Laboratory-confirmed or suspected SARS-CoV-2 infection Admitted to ICU in past 48 hours Respiratory failure (PaO₂ <70 mm Hg, SpO₂ <90% on room air, >30 breaths/min, labored breathing, respiratory distress, or need for oxygen ≥6 L/min) Key Exclusion Criteria Decision to limit life-sustaining treatment Therapy with ≥0.5 mg/kg per day of prednisone equivalent for ≥3 weeks Active and untreated bacterial, fungal, or parasitic infection Interventions High dose: DEX 20 mg IV once daily for 5 days, then DEX 10 mg IV once daily for 5 days (n = 270) SOC: DEX 6 mg IV once daily for 10 days (n = 239) or placebo (n = 37) Primary Endpoint All-cause mortality by Day 60	Participant Characteristics Median age 67 years; 76% men Median of 9 days from symptom onset to randomization 81% had ≥1 comorbidity 17% received RDV; <1% received tocilizumab Primary Outcome All-cause mortality by Day 60: 26% in high-dose arm vs. 27% in SOC arm (HR 0.96; 95% CI, 0.69–1.33; P = 0.79)	Key Limitation Comparator arm was initially a placebo but was changed to a standard dose of DEX after the RECOVERY trial results were released. Interpretation Among ICU patients with COVID-19–related respiratory failure, high-dose DEX did not significantly improve 60-day survival.
Open-Label RCT of Dexamethasone 6 mg or 20 mg in Hospitalized Adults With COVID-19 in the United States¹²
Key Inclusion Criteria PCR-confirmed SARS-CoV-2 infection Need for supplemental oxygen Key Exclusion Criteria Use of corticosteroids for >48 hours Death expected within 24 hours Interventions High dose: DEX 20 mg daily for 5 days, then DEX 10 mg daily for 5 days (n = 52) Low dose: DEX 6 mg daily for 10 days (n = 55) Primary Endpoint Clinical improvement by Day 28, as measured by a WHO OS Secondary Endpoints Mortality by Day 28 Number of ICU-free days by Day 28 Number of ventilator-free days by Day 28	Participant Characteristics Mean age: 58 years in low-dose arm vs. 56 years in high-dose arm 75% men; 50% White 36% with obesity; 29% with DM; 8% partially or fully vaccinated Received tocilizumab or baricitinib: 40% in low-dose arm vs. 21% in high-dose arm (P = 0.035) Primary Outcome Clinical improvement by Day 28: 78% of low-dose arm vs. 71% of high-dose arm (OR 1.45; 95% CI, 0.55–3.86; P = 0.40) Secondary Outcomes Mortality by Day 28 in low-dose arm vs. high-dose arm: All patients: 5 (9%) vs. 11 (21%; P = 0.08) Patients on HFNC oxygen or NIV: 0 of 15 vs. 6 of 14 (P = 0.025) No difference between arms in median number of ICU-free days or ventilator-free days by Day 28	Key Limitations Small, open-label study Enrollment halted after interim analysis showed higher mortality in subgroup of patients who were on HFNC oxygen or NIV in the high-dose arm. More patients in the low-dose arm received additional immunomodulators. Interpretation The use of high-dose DEX did not improve clinical outcomes in hospitalized patients with COVID-19, and it may have increased mortality among patients on HFNC oxygen or NIV.
Key: AE = adverse event; ARDS = acute respiratory distress syndrome; BMI = body mass index; CPAP = continuous positive airway pressure; CT = computed tomography; DEX = dexamethasone; DM = diabetes mellitus; ECMO = extracorporeal membrane oxygenation; FiO₂ = fraction of inspired oxygen; HFNC = high-flow nasal cannula; ICU = intensive care unit; IL = interleukin; IRS = intensive respiratory support; IV = intravenous; JAK = Janus kinase; LOS = length of stay; MV = mechanical ventilation; NIV = noninvasive ventilation; OS = ordinal scale; the Panel = the COVID-19 Treatment Guidelines Panel; PaO₂ = arterial partial pressure of oxygen; PCR = polymerase chain reaction; PEEP = positive end-expiratory pressure; PO = oral; RCT = randomized controlled trial; RDV = remdesivir; SAE = serious adverse event; SOC = standard of care; SOFA = sequential organ failure assessment; SpO₂ = oxygen saturation; TB = tuberculosis; WHO = World Health Organization

References

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