WHO Solidarity Trial Plus: An International Randomised Trial of Additional Treatments for COVID-19 in Hospitalised Patients Who Are All Receiving the Local Standard of Care in Nepal
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 5
- 主要终点
- Assessment of the Hospital Mortality
研究概览
简要总结
Proposal for Sub-Study to be conducted with the WHO Solidarity Plus Trial:
Apart from the data been collected as per the WHO Solidarity Trial Plus protocol, Nepal Health Research Council will conduct a sub-study to evaluate some components which are felt to be important in the local context but have not been included as part of the Solidarity Trial Plus. Rather that conducting a separate study, the following components can be evaluated by collecting additional data as a part of sub-study in the local context.
详细描述
Patients enrolled in the WHO Solidarity Plus trial will also be consented for this sub-study for further data collection in the following four categories. No additional tests or investigations will be performed.
- Socio-economic factors: Investigators have added the socio-demographic factors in our data collection tool to get insight into the socio-demographic distribution of the hospitalized patients enrolled in the study. These data will help to understand the disease distribution in the local context. These factors are listed in the table below.
- Laboratory investigations: There is no provision to collect the information on investigations including laboratory tests and radiological findings in the current WHO Solidarity protocol. These data will help to analyze the systemic effects of the study drugs and help to verify AEs/SAEs/SUSARs reported by the investigators. Hence, Investigators have added the information related to the various investigations in our study. Investigators will not collect additional bio samples or conduct any additional laboratory or radiological investigations. However, if such information is available, Investigators will collect such data and record the information in our local study database.
- Immunization status: Investigators currently do not have studies looking at impact of vaccines on hospitalization, severity and mortality in Nepal. Data related to the vaccination status is not included in the Solidarity protocol. After the availability of the vaccine, vaccination status may be a confounding factor to determine the mortality outcome. Hence, investigators plan to add vaccine status as one of the variables in the sub-study.
- Follow up after discharge: Investigators plan to add follow up visit or phone calls after the discharge which is not included in the current WHO Solidarity protocol. The study team will conduct follow up visits or phone calls each week to assess the status of the patients until 28 days and each month for six months thereafter from the date of first randomization. The follow up visits will be done by telephone call either to the patient or the patient's relative. Study team will ask about the condition of the patient since the time of discharge and find out general health status (normal versus abnormal), re-hospitalization, and mortality
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recently hospitalized (or already in hospital) with laboratory-confirmed COVID
- •In the view of their doctors, no contra-indication to any potentially relevant study drug.
- •Voluntary Participation
排除标准
- •In the view of the randomising doctor, ANY of the AVAILABLE study drugs are contra-indicated (eg, because of patient characteristics, chronic liver or heart disease, or some concurrent medication).
- •If expected to be transferred within 72 hours
研究组 & 干预措施
Artesunate
Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414
干预措施: Artesunate Injection (Drug)
Imatinib
Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414
干预措施: Artesunate Injection (Drug)
Infliximab
Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414
干预措施: Artesunate Injection (Drug)
结局指标
主要结局
Assessment of the Hospital Mortality
时间窗: The duration in the number of days calculated from the first date of randomization of the patient till the final outcome in the hospital that the first documented progression or death due to COVID 19 up to 28 days whichever comes first
To assess the incidence of hospital mortality in the patient who are receiving study drug in addition to local standard of care
次要结局
- Assessment of duration of hospital stay,(The duration in the number of days calculated from the first date hospitalization due to COVID 19 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 28 days)
- Initiation of ventilation(The number of days calculated from date of randomization until the date of initiation of ventilation, assessed up to 28 days)
- Assessment of Serious adverse reactions (SAE)(Number of Serious Adverse Effect (SAE) calculated from the day of randomization upto 28 days)
研究者
Dr. Pradip Gyanwali,MD
Executive Chief (Member Secretary)
Nepal Health Research Council