Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2.
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2
- Interventions
- Drug: Placebo oral tablet
- Registration Number
- NCT04625985
- Lead Sponsor
- Laboratorios Silanes S.A. de C.V.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- ≥ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin glycinate Metformin Glycinate 620 mg bid (PO) for 14 days plus standard treatment Placebo Placebo oral tablet Placebo tablet bid (PO) for 14 days plus standard treatment
- Primary Outcome Measures
Name Time Method Oxigen saturation Day 0 to Day 28 or patient discharge day Clinical status assessed by measurement of oxygen saturation in %: \>90.
respiratory rate 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 Day 0 to Day 28 or patient discharge day Assess length of supplementary oxygen
Days of supplementary mechanical ventilation Day 0 to Day 28 or patient discharge day Assess length of mechanical ventilation
Viral load 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 Day 0 to Day 28 or patient discharge day Clinical status assessed by measurement of systolic blood pressure in mmHg: \>90.
consciousness level Day 0 to Day 28 or patient discharge day Clinical status assessed by measurement of consciousness level: alertness
Days of hospitalization Day 0 to Day 28 or patient discharge day Assess length of hospitalization
Heart rate Day 0 to Day 28 or patient discharge day Clinical status assessed by measurement of heart rate in beats per minute: \<100 bpm.
temperature Day 0 to Day 28 or patient discharge day Clinical status assessed by measurement of axillary body temperature in °C: \<37.2.
- Secondary Outcome Measures
Name Time Method Changes in laboratory test results Day 0 to Day 28 or patient discharge day Changes in serum levels from security laboratories compared to baseline levels and between groups.
Toxicity of study drug assessed by incidence of adverse events (grade 3 or 4) Day 0 to Day 28 or patient discharge day Assess by incidence of Grade 3, Grade 4, and Serious Adverse Events (AEs)
Trial Locations
- Locations (1)
The American British Cowdray Medical Center, I.A.P
🇲🇽Mexico City, Mexico