Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Treatment of COVID-19 in Hospitalized Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Duration of hospitalization
研究概览
简要总结
This study will enroll 40 inpatients hospitalized for COVID-19 at Queens' Medical Center. Participants will be randomized 1:1 to Telmisartan (80 mg) vs placebo to be administered orally once daily x 21 days.
详细描述
The study is intended to assess, in a pilot study, the effect of telmisartan in mitigating the severity of COVID-19 related disease in hospitalized patients. Data on clinical course and lab values will be passively abstracted from Queen's standard of care evaluations on COVID-19 in-patients. Participants will be monitored closely as an outpatient if/when discharged prior to day 21. The only study-specific procedure will be a blood draw of ten (10) cc to be collected for research purposes at entry and at day 4 and day 21 of study for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of organ function/coagulation, inflammation, leukocyte chemotaxis, tissue remodeling/fibrosis and immune exhaustion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
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
- •Able to provide written informed consent prior to initiation of any study procedures.
- •Within 72 hours of initial hospitalization for acute COVID-19 disease management
- •Male or non-pregnant female adult ≥18 years of age at time of enrolment.
- •Able to easily swallow pills
排除标准
- •Systolic blood pressure less than 100 mmHg
- •Self-reported history of decompensated liver failure
- •Pregnancy or breast feeding
- •Allergy to the study medication
- •Current use of ARB, ACE inhibitors, or angiotensin receptor/neprilysin inhibitors (ARNIs). Blood pressure medications in other classes will be permitted as long as the systolic BP is >100 mmHg
- •Currently receiving vasopressors for hypotension
- •Prior reaction or intolerance to ARB, ACE Inhibitor or ANRI for whom study participation would not be advisable in the opinion of the study team
- •Current use of and on-going need for aliskiren, lithium, digoxin, and potassium sparing diuretics such as spironolactone
- •Participating in other drug clinical trials EXCEPT for other COVID-19 treatment trials which will be allowed with the permission of the Corresponding PI or Co-PI and concurrence of the treating physician/hospitalist
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10x upper limit of normal (ULN) within 24 hours of baseline
- •Absolute neutrophil count (ANC) < 1000/mL within 24 hours of baseline
- •Platelet count < 50,000/mL within 24 hours of baseline.
- •Patients with acute kidney injury (AKI) or chronic kidney disease (CKD) including individuals on hemodialysis may be enrolled based on the investigator's clinical judgement.
- •Any serious medical condition/ abnormality or other issues that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or suggests that the study is not in the patient's best interest
- •In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
研究组 & 干预措施
Telmisartan (80 mg)
Telmisartan 80 mg (given as two 40 mg encapsulated tablets) given orally each day x 21 days
干预措施: Telmisartan Oral Product (Drug)
Placebo
Two placebo capsules given orally each day x 21 days
干预措施: Placebo (Drug)
结局指标
主要结局
Duration of hospitalization
时间窗: Over the 21 day period of study
Number of days of patient's hospitalization
次要结局
- Duration of supplemental oxygen(over the 21 days of study)
- Duration of mechanical ventilation(over the 21 days of study)
- Number of deaths(over the 21 days of study)
- Number of grade 3 and greater adverse events(over the 21 days of study)
- Clinical severity of disease(On day 4 and day 21 of study)