A Prospective, randomized, open-labelled, active comparator trial of Indomethacin versus Paracetamol among hospitalized patients with confirmed Covid-19.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- IIT Madras
- 入组人数
- 300
- 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 the efficacy of Indomethacin compared to Paracetamol administered along with the standard care of treatment. This is a prospective, randomized, open-labelled, active comparator trial among hospitalized patients with confirmed COVID – 19.
Study Procedure
After the consent of the patient, they will be randomized to one of two drug regimens in an open label, randomized, active comparator design. The enrolled patients are with positive SARS – CoV -2, RT-PCR test results.
Study Drug
The usefulness of indomethacin has been established in Covid treatment in an earlier study. The 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 along with the standard care of treatment followed in the hospital for Covid-19
Table 1 – Indomethacin dose and frequency
| S. No. |
Patient BMI
Indomethacin sustained release (SR) formulation –
dose & frequency
|1
Less than 30
75 mg once daily for 5 days
|2
More than 30
75 mg x 2 for 5 days
|Proton Pump Inhibitor (Pantoprazole) 40 mg will be co-administered along with indomethacin
The drug indomethacin dose is less than or equal to that recommended in the pharmacokinetic study, based on experience and for pragmatic reason. Patients in the Paracetamol arm will receive paracetamol (Dolo–650mg x 4/d) for five daysalong with the hospital’s standard care of treatment for Covid-19. If the treating clinician believes that bacterial pneumonia is likely and requires a second antibacterial agent for “atypical†infection (an uncommon occurrence in COVID-19), patients may receive another agent (e.g., doxycycline or levofloxacin) as appropriate at the clinician’s discretion.
Expected outcome
This trial has been envisaged to bring out a cheap and effective treatment for the COVID – 19 pandemics. Indomethacin seems to satisfy scientifically all the requirements to fight the coronavirus and this academic 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 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 20 to 90 years RT – PCR Positive Hospitalised patients The case criteria for the study – Renal Function Test and Liver Functional Test should be normal at the screening; Oxygen saturation should be 95% or more.
排除标准
- •Hypersensitivity/Allergy to Drug Gastritis Recent Heart attack Severe Asthma Acute Kidney Injury.
- •Patients on immune suppressants •To Exclude pregnant and lactating mothers •Specify NSAID/Indomethacin allergy.
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 5 drug administration | Day 7 end of 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)