A Prospective, Randomized, open-labelled, active Comparator trial of Indomethacin and standard care versus Standard care among hospitalized severe Covid-19 patients.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- IIT Madras
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reduction in Covid-19 symptoms and the intervention is expected to be beneficial in reducing the Covid 19 symptoms than the comparator
研究概览
简要总结
This study is to record theefficacy of Indomethacin compared to paracetamol administered along with the standardcare of treatment. This is a prospective, randomized, open – labelled, activeComparator trial of Indomethacin and standard care versus Standard care amonghospitalized severe Covid-19 patients.
Studyprocedure RT – PCR positive severe Covid -19 patients will be randomized toone of the two drug regimens in an open label, randomized, active comparatordesign post obtaining their consent.
Study Drug
Theusefulness of indomethacin has been established in Covid treatment in anearlier study. Patients will be recruited to the indomethacin- or paracetamol-arm using a randomization algorithm (1:1 ratio). The following drug-dose and–frequency will be administered for the patients in the Indomethacin arm alongwith the standard care of treatment (without paracetamol) followed in thehospital for severe Covid-19;
Table1 – Indomethacin dose and frequency
| S. No. |
Patient BMI
Indomethacin sustained release (SR) formulation –
dose & frequency
|1
Less than 30
75 mg once daily for 7 days
|2
More than 30
75 mg x 2 for 7 days
|Proton Pump Inhibitor (Pantoprazole) 40 mg will be co-administered along with indomethacin
Thedrug dose is less than or equal to that recommended in the pharmacokineticstudy, based on experience and for pragmatic reason. Patients in the standardcare will receive paracetamol (Dolo – 650 mg x 4/d or iv) tillrequired. The dosage can be adjusted as per the decision of theclinician. Both are to be administered along with the hospital’s standardcare of treatment for severe Covid-19. Note: if the treatingclinician believes that bacterial pneumonia is likely and requires a secondantibacterial agent for “atypical†infection (an uncommon occurrence inCOVID-19), patients may receive another agent (e.g., doxycycline orlevofloxacin) as appropriate at the clinician’s discretion.
Expectedoutcome
This trial has been envisaged tobring out a cheap and effective treatment for the COVID – 19 pandemics. Indomethacinseems to satisfy scientifically all the requirements to fight the coronavirusand this trial aims to convert the science into a tangible treatment protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 20 to 90 years RT – PCR Positive Hospitalised patients dyspnea A blood oxygen saturation of 93% or less A ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (Pao2:Fio2) of less than 300 mm Hg, or infiltrates in more than 50% of the lung field.
排除标准
- •Hypersensitivity/Allergy to Drug Gastritis Recent Heart attack Severe Asthma Acute Kidney Injury Patients with known history of Indomethacin allergy will be excluded from the study.
结局指标
主要结局
Reduction in Covid-19 symptoms and the intervention is expected to be beneficial in reducing the Covid 19 symptoms than the comparator
时间窗: Day 0 screening | Day 1 to 7 drug | Day 28 end of the study
次要结局
- Safety both the intervention and comparator are routinely used drugs and are expected to be safe with no adverse effects(Day 0 screening)