Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Cetirizine and Famotidine in Reducing the Duration of Symptoms in Patients With COVID-19: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to resolution of symptoms
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of cetirizine and famotidine in reducing the duration of symptoms in patients with COVID-19. Secondary aims are to determine if cetirizine and famotidine decrease severity and duration of symptoms, incidence of hospitalizations, ICU admissions, and death.
详细描述
COVID-19 is a disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Patients with COVID-19 may present with a myriad of symptoms ranging from fever and cough to more severe symptoms such as shortness of breath. Cetirizine and famotidine are commonly administered medications that can be found over-the-counter. They are well tolerated and have low potential for drug-drug interaction. With it's anti-inflammatory properties via modulation of proinflammatory cytokines, cetirizine may be an effective symptomatic therapeutic for COVID-19. With possible antiviral properties, famotidine may have a role in therapy as well.
After a positive COVID test has been confirmed, participants with be randomized to take cetirizine and famotidine or a placebo for 10 days and the study medication will be shipped to them. Participants will record their symptoms for 30 days and any serious adverse events will be followed for up to 60 days.
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
- Double (Participant, 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
- •18 years old and above
- •positive COVID-19 test (antigen or PCR)
- •symptomatic from COVID-19
- •symptoms less than or equal to 7 days
排除标准
- •already enrolled in another COVID-19 drug study
- •chronically taking a H1-receptor antagonist or H2-receptor antagonist
- •have taken H1-receptor antagonist or H2-receptor antagonist less than 72 hours from expressed interest in the study.
- •history of an adverse reaction to H1 or H2-receptor antagonists
- •severe liver disease
- •severe renal disease
- •taking steroids
- •taking hydroxychloroquine and/or azithromycin
- •already participating in a COVID-19 vaccine trial
- •already received a COVID-19 vaccine
- •symptoms greater than 7 days
- •have had COVID-19 more than once
研究组 & 干预措施
cetirizine and famotidine
Participants testing positive for COVID-19 who are randomized to take cetirizine and famotidine for 10 days.
干预措施: Cetirizine and Famotidine (Drug)
Placebo
Participants testing positive for COVID-19 who are randomized to take a placebo to match cetirizine and famotidine for 10 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to resolution of symptoms
时间窗: Day 30
Participants will record their oral temperature and the presence of COVID-19 symptoms of cough, shortness of breath/difficulty breathing, fatigue, myalgias, headache, loss of taste, loss of smell, sore throat, rhinorrhea, congestion, nausea/vomiting, diarrhea, and feverishness/chills, twice daily for up to 14 days. The number of days until resolution of overall symptoms of COVID-19 will be compared between study arms.
次要结局
- Time to Resolution of Individual Symptoms(Day 30)
- Incidence of Hospitalization(Day 30)
- Incidence of Intensive Care Unit (ICU) Admission(Day 60)
- Severity of Symptoms(Day 30)
- Incidence of Death(Day 60)
研究者
Humphrey Lam
Assistant Professor
Emory University