Randomised Controlled Trial to compare efficacy of standard of care alone and in combinationwith homoeopathic treatment of COVID-19 Placebo - HOM_COVID19

Central Council for Research in Homoeopathy0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 2 期
状态: 已完成
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•Age > 18 years
•Case definitions for inclusion in the study will include moderate and severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVID19 issued by Ministry of Health and Family Welfare, Govt of India on 13 June 2020 .
•oModerate: Pneumonia with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, Respiratory Rate more or equal to 24 per minute.
•ï?§Adolescent or adult with clinical signs of Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air.
•ï?§Acute Respiratory Distress Syndrome Onset:
•ï?§New or worsening respiratory symptoms within one week of known clinical insult.
•ï?§Chest imaging (Chest X ray and portable bed side lung ultrasound): bilateral opacities, not fully explained by effusions, lobar or lung collapse, or nodules. Origin of Pulmonary infiltrates: respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g. echocardiography) to exclude hydrostatic cause of infiltrates/ oedema if no risk factor present.
•ï?§Oxygenation impairment in adults:
•Mild ARDS: 200 mmHg < PaO2/FiO2 <= 300 mmHg (with PEEP or CPAP >=5 cm H2O)
•Moderate ARDS: 100 mmHg < PaO2/FiO2 <=200 mmHg with PEEP >=5 cm H2O)
•Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS
•CoV-2 test result pending with a high clinical suspicion as defined by:
•oCough of <10d duration
•oBilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air
•oNo alternative explanation for respiratory symptoms
•Scheduled for admission or enrolled within 48h of hospital admission

排除标准

•Pregnant and lactating women, infants and neonates
•Not willing to give consent for adjuvant treatment
•In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
•Symptoms of acute respiratory tract infection for > 10d before randomisation
•Death within 24 Hrs. of admission

研究者

发起方

Central Council for Research in Homoeopathy

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