Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 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
- Maximum Clinical Severity of Disease Since Entry
研究概览
简要总结
This study will enroll 40 symptomatic outpatients tested positive for Coronavirus 2019 (COVID-19). Patients to be randomized 1:1 to Telmisartan (40 mg) vs placebo to be administered orally once daily x 21 days. Daily, the study patients will be asked to keep a record of the severity of their fever, dyspnea and fatigue and take their blood pressure (BP) and temperature. Study visits to occur on day 1 (entry), day 4, day 10 and day 21. Oro-pharyngeal swabs, and approximately 25 cc of blood will be collected at each study visit for safety labs and for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of inflammation, coagulation and fibrosis.
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)
盲法说明
Placebo controlled trial
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.
- •Understands and agrees to comply with planned study procedures including self testing of blood pressure daily
- •Male or non-pregnant female adult ≥18 years of age at time of enrolment.
- •Has laboratory-confirmed severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection as determined by FDA-approved commercial or public health assay in any specimen collected ideally < 72 hours prior to randomization. Exceptions to the <72 hr inclusion criteria may be made at the discretion of the investigator.
- •Positive for COVID-19 symptoms: fever defined as a temperature of >100.4 on study screening or self-report of daily fever at home OR shortness of breath of any degree OR fatigue causing greater than minimal interference with usual social & functional activities
- •Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study
- •Able to easily swallow pills
排除标准
- •Immediate need for hospitalization on screening
- •Systolic blood pressure less than 100 mmHg
- •Self-reported presence of chronic kidney disease or requiring dialysis
- •Self-reported history of liver failure or untreated hepatitis B or C
- •Pregnancy or breast feeding
- •Allergy to the study medication
- •Current use of angiotensin receptor blocker (ARB) or angiotensin converting enzyme (ACE) Inhibitor medications. Other blood pressure medications will be permitted in the systolic BP is higher than 90 mmHg
- •Prior reaction or intolerance to ARB or ACE Inhibitor
- •Use of aliskiren in patients with diabetes
- •Current use of and on-going need for lithium, digoxin, potassium sparing diuretics such as spironolactone
- •Current use of and need for potassium supplements
- •Current or past participation in a research study within 12 weeks prior to the Screening Visit unless cleared by Study Team
- •Inability to drive safely for study visits
- •Subjects, who, in the opinion of the investigator, are unable to comply with the protocol evaluation, or for whom study participation may not be advisable
研究组 & 干预措施
Telmisartan
Telmisartan 40 mg po daily x 21 days
干预措施: Telmisartan 40mg (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Clinical Severity of Disease Since Entry
时间窗: maximum clinical severity of disease post entry evaluated over the 21 day clinical study
We utilized the World Health Organization (WHO) COVID-19 7-point ordinal scale: 1 (not hospitalized, no limitations on activities), 2 (not hospitalized limitation on activities); 3 (hospitalized, not requiring oxygen); 4 (hospitalized and requiring oxygen); 5 (hospitalized, on non-invasive ventilation or high flow oxygen devices); 6 (hospitalized, on invasive mechanical ventilation or ECMO) and 7 (death). A symptom scale was devised to allow 'fine tuning' within the 2.0 WHO category of 'not hospitalized but limitation on activities' based on severity (no symptoms, mild, moderate, moderately severe and severe symptoms) of fever, breathing and fatigue severity scale (0 to 4 points for each factor allowing a max score of 12). A WHO scale within the '2' category was then 'fine tuned' as follows: 2.0 (\</=3 symptom points), 2.25 (4-6 symptom points), 2.5 (7-9 symptom points), and 2.75 (10-12 symptom points).
次要结局
- Number of Adverse Events(Through study completion at day 21 of study)