Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized 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
- 撤回
- 试验地点
- 1
- 主要终点
- Viral Load
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary to SARS-CoV-2.
详细描述
After being informed about the study and potential risks, all patients will give written informed consent and undergo a 1 day screening period to determine the eligibility for study entry. At day 0, patients who meet the eligibility requirements will be randomized in a double blind (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 will be 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
- •Metabolic syndrome or type 2 diabetes
- •Coronavirus infection, severe acute respiratory syndrome SARS-CoV- 2 confirmed by the Polymerase Chain Reaction test (PCR) ≤ 4 days before of the randomization.
- •Hospitalized patient.
- •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
研究组 & 干预措施
Metformin glycinate
620 mg bid (PO) plus standard treatment for 14 days
干预措施: metformin glycinate (Drug)
Placebo
Placebo tablets bid (PO) plus standard treatment for 14 days
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Viral Load
时间窗: Day 0 to Day 8 or patient discharge day
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
次要结局
- Days of Hospitalization(Day 0 to day 28 or patients discharge day)
- Normalization of oxigen saturation(Day 0 to day 28 or patient discharge day)
- Change in serum Creatine kinase-MB levels(Day 0 to day 28 or patients discharge day)
- Days of supplementary mechanical ventilation if apply(Day 0 to day 28 or patient discharge day)
- Normalization of fever(Day 0 to day 28 or patient discharge day)
- Number of deaths(Day 0 to day 28 or patient discharge day)
- Change in serum Troponin I(Day 0 to day 28 or patients discharge day)
- Change in Serum creatinine levels(Day 0 to day 28 or patients discharge day)
- Days of supplementary oxygen if apply(Day 0 to day 28 or patient discharge day)
- Change in serum aspartate aminotransferase levels(Day 0 to day 28 or patients discharge day)
- Incidence of adverse event(Day 0 to day 28 or patients discharge day)