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Effectiveness of glucocorticoid therapy in patients with severe coronavirus disease 2019: protocol of a randomized
Yuan-Yuan Qin1, Yi-Hong Zhou, Yan-Qiu Lu
1Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing 400036, China.
Insights
This randomized trial investigates if methylprednisolone improves outcomes for severe 2019-nCoV pneumonia. Results will clarify glucocorticoid use in critical coronavirus infections.
Area of Science:
- Critical care medicine
- Infectious diseases
- Pharmacology
Background:
- The 2019 novel coronavirus (2019-nCoV) outbreak presents a significant global health challenge.
- The efficacy of glucocorticoid therapy for severe 2019-nCoV-associated lower respiratory tract infections remains uncertain.
- Previous coronavirus outbreaks have seen varied use of glucocorticoids for respiratory symptoms, lacking definitive evidence.
Purpose of the Study:
- To evaluate the effectiveness of adjunctive methylprednisolone therapy in patients with severe 2019-nCoV pneumonia.
- To provide evidence for or against the use of systemic glucocorticoids in severe coronavirus disease 2019.
Main Methods:
- An open-labeled, randomized controlled trial enrolling 48 subjects.
- Intervention group received intravenous methylprednisolone (1-2 mg/kg/day for 3 days); control group received no glucocorticoids.
- Primary endpoint: clinical improvement rate. Secondary endpoints: timing of improvement, ventilation duration, hospitalization, adverse events, and mortality.
Main Results:
- Primary endpoint data on clinical improvement rate is pending.
- Secondary endpoint data on ventilation duration, hospitalization, adverse events, and mortality is pending.
- The study aims to collect comprehensive data over a 28-day follow-up period.
Conclusions:
- Definitive evidence regarding systemic glucocorticoid use in severe coronavirus respiratory disease is lacking.
- This study seeks to clarify the role of methylprednisolone in managing severe 2019-nCoV infections.
- Findings will inform clinical guidelines for treating critical coronavirus-related respiratory illness.
Background:
At the end of 2019, a novel coronavirus outbreak causative organism has been subsequently designated the 2019 novel coronavirus (2019-nCoV). The effectiveness of adjunctive glucocorticoid therapy in the management of 2019-nCoV-infected patients with severe lower respiratory tract infections is not clear, and warrants further investigation.
Methods:
The present study will be conducted as an open-labeled, randomized, controlled trial. We will enrol 48 subjects from Chongqing Public Health Medical Center. Each eligible subject will be assigned to an intervention group (methylprednisolone via intravenous injection at a dose of 1-2 mg/kg/day for 3 days) or a control group (no glucocorticoid use) randomly, at a 1:1 ratio. Subjects in both groups will be invited for 28 days of follow-up which will be scheduled at four consecutive visit points. We will use the clinical improvement rate as our primary endpoint. Secondary endpoints include the timing of clinical improvement after intervention, duration of mechanical ventilation, duration of hospitalization, overall incidence of adverse events, as well as rate of adverse events at each visit, and mortality at 2 and 4 weeks.
Discussion:
The present coronavirus outbreak is the third serious global coronavirus outbreak in the past two decades. Oral and parenteral glucocorticoids have been used in the management of severe respiratory symptoms in coronavirus-infected patients in the past. However, there remains no definitive evidence in the literature for or against the utilization of systemic glucocorticoids in seriously ill patients with coronavirus-related severe respiratory disease, or indeed in other types of severe respiratory disease. In this study, we hope to discover evidence either supporting or opposing the systemic therapeutic administration of glucocorticoids in patients with severe coronavirus disease 2019.
Trial Registration:
ClinicalTrials.gov, ChiCTR2000029386, http://www.chictr.org.cn/showproj.aspx?proj=48777.
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