Severe Acute Respiratory Syndrome Coronavirus 2
Conditions
Keywords
SARS-COV 2, Severe acute respiratory syndrome
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.
Interventions
Participants randomized to metformin glycinate will take 620 mg bid (PO) for 14 days plus standard treatment
DRUGPlacebo oral tablet
Participants randomized to placebo will take a tablet bid (PO) for 14 days in plus standard treatment
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: Metformin glycinate 620 mg bid (PO) for 14 days plus standard treatment Control group: placebo bid (PO) for 14 days plus standard treatment Comparator: Placebo Placebo pill bid (PO) for 14 days plus standard treatment
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. Coronavirus infection, severe acute respiratory syndrome (SARS-CoV)-2 confirmed by the polymerase chain reaction (PCR) test ≤ 4 days before randomization. 4. Hospitalized 5. 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 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days of supplementary mechanical ventilation | Day 0 to Day 28 or patient discharge day | Assess length of mechanical ventilation |
| Days of hospitalization | Day 0 to Day 28 or patient discharge day | Assess length of hospitalization |
| Days of supplementary oxygen if applies | Day 0 to Day 28 or patient discharge day | Assess length of supplementary oxygen |
| 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 |
| consciousness level | Day 0 to Day 28 or patient discharge day | Clinical status assessed by measurement of consciousness level: alertness |
| temperature | Day 0 to Day 28 or patient discharge day | Clinical status assessed by measurement of axillary body temperature in °C: \<37.2. |
| systolic blood pressure | Day 0 to Day 28 or patient discharge day | Clinical status assessed by measurement of systolic blood pressure in mmHg: \>90. |
| Oxigen saturation | Day 0 to Day 28 or patient discharge day | Clinical status assessed by measurement of oxygen saturation in %: \>90. |
| 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. |
| 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, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Mexico
Outcome results
None listed