Metabolic Syndrome, Severe Acute Respiratory Syndrome Coronavirus 2, Type 2 Diabetes
Conditions
Keywords
SARS-CoV 2, Metabolic Syndrome, Type 2 diabetes, Severe Acute Respiratory Syndrome, Metformin glycinate
Brief summary
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.
Detailed description
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.
Interventions
Participants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days
DRUGPlacebo oral tablet
Participants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days
Sponsors
Laboratorios Silanes S.A. de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Parallel assignment experimental and placebo tablets will have same physical appearance and medicine box will be identified by kit number
Intervention model description
Experimental group: Metformin glycinate 620 mg bid (PO) plus standard treatment for 14 days. Control Group: Placebo bid (PO) plus standard treatment for 14 days plus
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years old 2. Ability to understand and the willingness to sign a written informed consent document before any study procedure 3. Metabolic syndrome or type 2 diabetes 4. Coronavirus infection, severe acute respiratory syndrome SARS-CoV- 2 confirmed by the Polymerase Chain Reaction test (PCR) ≤ 4 days before of the randomization. 5. Hospitalized patient. 6. Radiographic evidence of pulmonary infiltrates
Exclusion criteria
1. Participation in any other clinical trial of an experimental treatment for COVID-19 2. Evidence of multi-organ failure 3. Require mechanical ventilation before randomization 4. Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days of supplementary mechanical ventilation if apply | Day 0 to day 28 or patient discharge day | Assess length of mechanical ventilation |
| Days of Hospitalization | Day 0 to day 28 or patients discharge day | Assess length of hospitalization |
| Normalization of fever | Day 0 to day 28 or patient discharge day | Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate |
| Normalization of oxigen saturation | Day 0 to day 28 or patient discharge day | Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate |
| Number of deaths | Day 0 to day 28 or patient discharge day | Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate |
| Days of supplementary oxygen if apply | Day 0 to day 28 or patient discharge day | Assess length of supplementary oxygen |
| Change in serum Troponin I | Day 0 to day 28 or patients discharge day | Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l |
| Change in serum aspartate aminotransferase levels | Day 0 to day 28 or patients discharge day | Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l |
| Change in serum Creatine kinase-MB levels | Day 0 to day 28 or patients discharge day | Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l |
| Incidence of adverse event | Day 0 to day 28 or patients discharge day | Assess by incidence of grade 3, grade 4 and Serious adverse events |
| Change in Serum creatinine levels | Day 0 to day 28 or patients discharge day | Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl |
Countries
Mexico
Outcome results
None listed