Randomized Open Investigation Determining Steroid Dose in Severe COVID-19: The ROIDS-Dose Clinical Trial

Rabascall, Carlos X; Lou, Becky; Dhar, Sean; Ḥasan, Zubair; Fryman, Craig; Izard, Stephanie; Makaryus, Mina; Acharya, Sudeep; Mastroianni, F.; Kämper, M.; Duenas, Sean Michael; Gong, Jonathan; Shah, Dimple; Khanijo, Sameer; Ying, Daniel; Habibullah, Junaid; Kim, Dae Hyeon; Butzko, Ryan; Oks, Margarita; Birnbaum, Brian; Moore, Jonathan P.; Singh, Anup; Quintero, Luis D; Lau, Michael; Honigman, Jared; Hilewitz, Ayelet; Shah, Kalpana; Simonson, Joseph; Frank, Matthew J.; Tsegaye, Adey; Narasimhan, Mangala; Greenberg, Harly; Hahn, Stella

doi:10.7759/cureus.31086

Cited by 5 publications

(27 citation statements)

References 29 publications

(43 reference statements)

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“…We contacted trial authors twice, allowing at least 3 weeks for them to reply, in case of missing data or information about study design. 6,7,[21][22][23][24][25][26][27][28][29]…”

Section: Data Extraction and Managementmentioning

confidence: 99%

Section: Trial Characteristicsmentioning

confidence: 99%

“…Eight trials were conducted in high-income countries, 6,7,19,21,26,28,39,40 seven in middle-income countries, 18,[22][23][24][25]27,29 and two in both. 20,38 Nine were multicentre trials 6,[18][19][20]26,28,[38][39][40] and eight single-centre trials. 7,[21][22][23][24][25]27,29 Only four trials were conducted solely in the ICU 6,18,19,25 ; the remaining trials were conducted in patients admitted to the general wards 7,[20][21][22][23][24]26,28,29,[38][39]…”

Section: Trial Characteristicsmentioning

confidence: 99%

“…20,38 Nine were multicentre trials 6,[18][19][20]26,28,[38][39][40] and eight single-centre trials. 7,[21][22][23][24][25]27,29 Only four trials were conducted solely in the ICU 6,18,19,25 ; the remaining trials were conducted in patients admitted to the general wards 7,[20][21][22][23][24]26,28,29,[38][39][40] or both. 20,27 Dexamethasone doses in the high-dose group varied from 12 mg 20 to 24 mg daily 22 with one trial using weight-based doses.…”

Section: Trial Characteristicsmentioning

confidence: 99%

“…20,27 Dexamethasone doses in the high-dose group varied from 12 mg 20 to 24 mg daily 22 with one trial using weight-based doses. 28 The intervention was given for up to 10 days. Additional trial characteristics are presented in Table 1.…”

Section: Trial Characteristicsmentioning

confidence: 99%

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Dexamethasone doses in patients with COVID‐19 and hypoxia: A systematic review and meta‐analysis

Munch,

Granholm,

Maláska

et al. 2023

Acta Anaesthesiol Scand

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BackgroundThe optimal dose of dexamethasone for severe/critical COVID‐19 is uncertain. We compared higher versus standard doses of dexamethasone in adults with COVID‐19 and hypoxia.MethodsWe searched PubMed and trial registers until 23 June 2023 for randomised clinical trials comparing higher (>6 mg) versus standard doses (6 mg) of dexamethasone in adults with COVID‐19 and hypoxia. The primary outcome was mortality at 1 month. Secondary outcomes were mortality closest to 90 days; days alive without life support; and the occurrence of serious adverse events/reactions (SAEs/SARs) closest to 1 month. We assessed the risk of bias using the Cochrane RoB2 tool, risk of random errors using trial sequential analysis, and certainty of evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE).ResultsWe included eight trials (2478 participants), of which four (1293 participants) had low risk of bias. Higher doses of dexamethasone probably resulted in little to no difference in mortality at 1 month (relative risk [RR] 0.97, 95% CI: 0.79–1.19), mortality closest to Day 90 (RR 1.01, 95% CI: 0.86–1.20), and SAEs/SARs (RR 1.00, 95% CI: 0.97–1.02). Higher doses of dexamethasone probably increased the number of days alive without invasive mechanical ventilation and circulatory support but had no effect on days alive without renal replacement therapy.ConclusionsBased on low to moderate certainty evidence, higher versus standard doses of dexamethasone probably result in little to no difference in mortality, SAEs/SARs, and days alive without renal replacement therapy, but probably increase the number of days alive without invasive mechanical ventilation and circulatory support.

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“…We contacted trial authors twice, allowing at least 3 weeks for them to reply, in case of missing data or information about study design. 6,7,[21][22][23][24][25][26][27][28][29]…”

Section: Data Extraction and Managementmentioning

confidence: 99%

Section: Trial Characteristicsmentioning

confidence: 99%

Section: Trial Characteristicsmentioning

confidence: 99%

Section: Trial Characteristicsmentioning

confidence: 99%

Section: Trial Characteristicsmentioning

confidence: 99%

See 3 more Smart Citations

Dexamethasone doses in patients with COVID‐19 and hypoxia: A systematic review and meta‐analysis

Munch,

Granholm,

Maláska

et al. 2023

Acta Anaesthesiol Scand

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Efficacy and safety of glucocorticoids in the treatment of COVID-19: a systematic review and meta-analysis of RCTs

Ye,

Li,

Luo

et al. 2024

Clin Exp Med

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In the realm of acute respiratory infections, coronavirus disease-19 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), poses a global public health challenge. The application of corticosteroids (CSs) in COVID-19 remains a contentious topic among researchers. Accordingly, our team performed a comprehensive meta-analysis of randomized controlled trials (RCTs) to meticulously evaluate the safety and efficacy of CSs in hospitalized COVID-19 patients. To explore efficacy of CSs in the treatment of COVID-19 patients, we meticulously screened RCTs across key databases, including PubMed, Web of Science, Embase, Cochrane Library, ClinicalTrials.gov, as well as China's CNKI and Wanfang Data. We focused on assessing the 28 days mortality rates. We evaluated the data heterogeneity using the Chi-square test and I2 values, setting significance at 0.1 and 50%. Data from 21 RCTs involving 5721 participants were analyzed. The analysis did not demonstrate a significant association between CSs intervention and the 28 days mortality risk in hospitalized COVID-19 patients (relative risk [RR] = 0.93; 95% confidence interval [95% CI]: 0.84–1.03; P = 0.15). However, subgroup analysis revealed a significant reduction in 28 days mortality among patients with moderate-to-severe COVID-19 (RR at 0.85; 95% CI: 0.76–0.95; P = 0.004). Specifically, short-term CS administration (≤ 3 days) was associated with a substantial improvement in clinical outcomes (RR = 0.24; 95% CI: 0.09–0.63; P = 0.004), as was longer-term use (≥ 8 days) (RR = 0.88; 95% CI: 0.77–0.99; P = 0.04). Additionally, in patients with moderate-to-severe COVID-19, the administration of dexamethasone increased the number of 28 days ventilator-free days (Mean Difference = 1.92; 95% CI: 0.44–3.40; P = 0.01). Methylprednisolone also demonstrated significant benefits in improving clinical outcomes (RR = 0.24; 95% CI: 0.09–0.63; P = 0.004). Our meta-analysis demonstrated that although there is no significant difference in 28 days mortality rates among hospitalized COVID-19 patients, the use of CSs may be beneficial in improving clinical outcomes in moderate or severe COVID-19 patients. There was no significant increase in the occurrence of adverse events associated with the use of CSs. Our meta-analysis provides evidence that while CSs may not be suitable for all COVID-19 patients, they could be effective and safe in severely ill COVID-19 patients. Consequently, it is recommended to administer CSs for personalized treatments in COVID-19 cases to improve the clinical outcomes while minimizing adverse events.

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Intermediate- to high-dose dexamethasone versus low-dose dexamethasone in patients with COVID-19 requiring respiratory support: a systematic review and meta-analysis of randomized trials

2023

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The present review critically appraised the randomized clinical trials that compared mortality outcomes between intermediate- to high-dose dexamethasone and low-dose dexamethasonein patients with COVID-19 and reported pooled mortality risk estimates associated with these two dosing regimens of dexamethasone. The systematic searching of electronic databases was limited to randomized clinical trials that compared mortality outcomes between intermediate- to high-dose dexamethasone with low-dose dexamethasone in patients with COVID-19 requiring respiratory support. The primary outcome of interest in this review was all-cause mortality. A total of eight trials with 1800 patients randomized to receive intermediate to high-dose dexamethasone and 1715 patients randomized to low-dose dexamethasone were included. The meta-analysis of six trials revealed no significant difference in the risk of 28-day all-cause mortality between intermediate- to high-dose dexamethasone and low-dose dexamethasone (odds ratio 1.16, 95% confidence interval, 0.77–1.74). Similarly, the meta-analysis of five trials revealed no significant difference between the two doses regarding 60-day all-cause mortality (odds ratio 0.96, 95% confidence interval 0.74–1.26). The results suggest intermediate- to high-dose dexamethasone to be as effective as low-dose dexamethasone in reducing the risk of mortality among patients with COVID-19 requiring respiratory support. However, higher dexamethasone doses could expose patients with COVID-19 to an increased risk of adverse events, such as hyperglycemia.

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Randomized Open Investigation Determining Steroid Dose in Severe COVID-19: The ROIDS-Dose Clinical Trial

Cited by 5 publications

References 29 publications

Dexamethasone doses in patients with COVID‐19 and hypoxia: A systematic review and meta‐analysis

Dexamethasone doses in patients with COVID‐19 and hypoxia: A systematic review and meta‐analysis

Efficacy and safety of glucocorticoids in the treatment of COVID-19: a systematic review and meta-analysis of RCTs

Intermediate- to high-dose dexamethasone versus low-dose dexamethasone in patients with COVID-19 requiring respiratory support: a systematic review and meta-analysis of randomized trials

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