Adaptive Study to Demonstrate Efficacy and Safety of Metformin Glycinate for the Treatment of Hospitalized Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Oxigen saturation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the metformin glycinate and standard treatment of the hospital in hospitalized patients with Severe Acute Respiratory Syndrome secondary to SARS-CoV2.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1 day screening period to determine eligibility for study entry. At day 0, patients who meet the eligibility requirements will be randomized in a double blind manner (participant and investigator) in a 1:1 ratio to metformin glycinate (620 mg, taken orally, twice daily) plus standard treatment or placebo (taken orally, twice daily) plus standard treatment, both for 14 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Parallel Assignment Experimental and placebo tablets will have same physical appearance and medicine box will be identified by kit number.
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
- •Ability to understand and the willingness to sign a written informed consent document before any study procedure
- •Coronavirus infection, severe acute respiratory syndrome (SARS-CoV)-2 confirmed by the polymerase chain reaction (PCR) test ≤ 4 days before randomization.
- •Hospitalized
- •Radiographic evidence of pulmonary infiltrates
排除标准
- •Participation in any other clinical trial of an experimental treatment for COVID-19
- •Evidence of multi-organ failure
- •Require mechanical ventilation before randomization
- •Pregnant patients
- •Patients with kidney failure, cancer and among other conditions that due to their treatment and / or baseline condition, affect the distribution, bioavailability and elimination of the studied drug
研究组 & 干预措施
Metformin glycinate
620 mg bid (PO) for 14 days plus standard treatment
干预措施: Metformin Glycinate (Drug)
Placebo
Placebo tablet bid (PO) for 14 days plus standard treatment
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Oxigen saturation
时间窗: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of oxygen saturation in %: \>90.
respiratory rate
时间窗: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of respiratory rate in breaths per minute: \<24 bpm,
Days of supplementary oxygen if applies
时间窗: Day 0 to Day 28 or patient discharge day
Assess length of supplementary oxygen
Days of supplementary mechanical ventilation
时间窗: Day 0 to Day 28 or patient discharge day
Assess length of mechanical ventilation
Viral load
时间窗: Day 0 to Day 28 or patient discharge day
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
systolic blood pressure
时间窗: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of systolic blood pressure in mmHg: \>90.
consciousness level
时间窗: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of consciousness level: alertness
Days of hospitalization
时间窗: Day 0 to Day 28 or patient discharge day
Assess length of hospitalization
Heart rate
时间窗: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of heart rate in beats per minute: \<100 bpm.
temperature
时间窗: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of axillary body temperature in °C: \<37.2.
次要结局
- Changes in laboratory test results(Day 0 to Day 28 or patient discharge day)
- Toxicity of study drug assessed by incidence of adverse events (grade 3 or 4)(Day 0 to Day 28 or patient discharge day)