The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19): (Randomized Clinical Trial)
试验速览
- 阶段
- 3 期
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Time to clinical improvement,
研究概览
简要总结
There is an urgent need to explore therapeutic options for SARS-CoV-2 in order to face the pandemic. The selected intervention was based on that zafirlukast will have dual effect; first it will block the virus replication through inhibiting the COVID19 helicase that is involved in virus replication and secondly by reducing the inflammation through antagonizing the leukotriene receptor.
The purpose of this study is to evaluate the clinical efficacy and safety of Leukotriene receptor antagonist in the treatment of moderate cases of COVID-19 patients.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age of 18 years or above
- •Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection.
- •Able to sign the consent form and agree to clinical samples collection
- •Moderate symptomatic COVID-19 patients, (any or all of the followings: fever or cough or SOB)
- •Admitted to the hospital (outside the ICU)
- •Patients had to be enrolled within 10 days of symptoms onset.
- •willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Asthmatic patient using antiasthma medications
- •Being in the hospital or in home isolation for more than 72 hours before the start of the study drug.
- •Known sensitivity/allergy to the study drug
- •Patient refused
- •Chronic liver disease
- •Severe mental disorder
- •Unstable patients requiring ICU admission
- •Participating in other clinical trial
研究组 & 干预措施
Treatment
Zafirlukast plus the standard treatment according to Saudi CDC protocol (combination experimental arm)
Description of investigational drug Zafirlukast is leukotriene receptor antagonist (LTRA) for the maintenance treatment of asthma. It is available as a tablet and is usually dosed twice daily. It is approved by USFDA and currently commercially marketed under the name of Accolate 20 mg oral tablet. The drug will be acquired from the pharmacy and will be received by the patient during the hospital admission via research coordinator. The study drug will be stored in at room temperature (15 - 25 c) in the hospital's pharmacy and a delegated pharmacist will be responsible for dispensing and return of any drugs.
The study drug will be administrated to the patient in the dose of 20 mg orally twice daily for 10 days (fixed dose with no staring or escalating dose).
干预措施: Leukotriene Receptor Antagonist (Drug)
Control
placebo plus the standard treatment according to Saudi CDC protocol
干预措施: Placebo (Other)
结局指标
主要结局
Time to clinical improvement,
时间窗: 28Day
The time from symptoms resolved: No fever for 72 hours, no cough, no SOB or live discharge from the hospital, whichever came first.
次要结局
- Escalate therapy.(28Day)
- PCR test(Day14)
- Length of hospital stay.(28Day)
- Duration of fever(28Day)