2.Effectiveness of glucocorticoid therapy in patients with severe coronavirus disease 2019: protocol of a randomized controlled trial.
Yuan-Yuan QIN ; Yi-Hong ZHOU ; Yan-Qiu LU ; Feng SUN ; Sen YANG ; Vijay HARYPURSAT ; Yao-Kai CHEN
Chinese Medical Journal 2020;133(9):1080-1086
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.
Betacoronavirus
;
drug effects
;
Coronavirus Infections
;
drug therapy
;
Glucocorticoids
;
adverse effects
;
therapeutic use
;
Humans
;
Pandemics
;
Pneumonia, Viral
;
drug therapy
;
Randomized Controlled Trials as Topic
;
Severity of Illness Index
3.Asymptomatic cryptococcal antigenemia in HIV-infected patients: a review of recent studies.
Xiao-Lei XU ; Ting ZHAO ; Vijay HARYPURSAT ; Yan-Qiu LU ; Yan LI ; Yao-Kai CHEN
Chinese Medical Journal 2020;133(23):2859-2866
The prevalence of asymptomatic cryptococcal antigenemia (ACA) in human immunodeficiency virus (HIV) infected individuals has been observed to be elevated. The prevalence of ACA ranges from 1.3% to 13%, with different rates of prevalence in various regions of the world. We reviewed studies conducted internationally, and also referred to two established expert consensus guideline documents published in China, and we have concluded that Chinese HIV-infected patients should undergo cryptococcal antigen screening when CD4 T-cell counts fall below 200 cells/μL and that the recommended treatment regimen for these patients follow current World Health Organization guidelines, although it is likely that this recommendation may change in the future. Early screening and optimized preemptive treatment for ACA is likely to help decrease the incidence of cryptococcosis, and is lifesaving. Further studies are warranted to explore issues related to the optimal management of ACA.
AIDS-Related Opportunistic Infections
;
CD4 Lymphocyte Count
;
China
;
Cryptococcosis/epidemiology*
;
Cryptococcus
;
HIV Infections/complications*
;
Humans
;
Meningitis, Cryptococcal
4.Comparative effectiveness and safety of ribavirin plus interferon-alpha, lopinavir/ritonavir plus interferon-alpha, and ribavirin plus lopinavir/ritonavir plus interferon-alpha in patients with mild to moderate novel coronavirus disease 2019: study protocol.
Yan-Ming ZENG ; Xiao-Lei XU ; Xiao-Qing HE ; Sheng-Quan TANG ; Yao LI ; Yin-Qiu HUANG ; Vijay HARYPURSAT ; Yao-Kai CHEN
Chinese Medical Journal 2020;133(9):1132-1134
Adult
;
Aged
;
Antiviral Agents
;
administration & dosage
;
Betacoronavirus
;
Coronavirus Infections
;
drug therapy
;
Drug Therapy, Combination
;
Humans
;
Interferon-alpha
;
administration & dosage
;
Lopinavir
;
administration & dosage
;
Middle Aged
;
Pandemics
;
Pneumonia, Viral
;
drug therapy
;
Randomized Controlled Trials as Topic
;
Ribavirin
;
administration & dosage
;
Ritonavir
;
administration & dosage
5. Effectiveness of glucocorticoid therapy in patients with severe novel coronavirus pneumonia: protocol of a randomized controlled trial
Yi-Hong ZHOU ; Yuan-Yuan QIN ; Yan-Qiu LU ; Feng SUN ; Sen YANG ; Vijay HARYPURSAT ; Sheng-Quan TANG ; Yin-Qiu HUANG ; Xiao-Qing HE ; Yan-Ming ZENG ; Yao LI ; Xiao-Lei XU ; Ting ZHAO ; Yao-Kai CHEN
Chinese Medical Journal 2020;133(0):E020-E020
Background:
At the end of 2019, a novel coronavirus outbreak emerged in Wuhan, China, and its causative organism has been subsequently designated the 2019 novel coronavirus (2019-nCoV). The virus has since rapidly spread to all provinces and autonomous regions of China, and to countries outside of China. Patients who become infected with 2019-nCoV may initially develop mild upper respiratory tract symptoms. However, a significant fraction of these patients goes on to subsequently develop serious lower respiratory disease. The effectiveness of adjunctive glucocorticoid therapy uses 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-labelled, randomised 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 1-2mg/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 4 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 severe coronavirus disease 2019 (COVID-19) patients.
Trial registration
ClinicalTrials.gov, ChiCTR2000029386, http://www.chictr.org.cn/showproj.aspx?proj=48777.