Name (Synonyms) | Correlation |
---|
Name (Synonyms) | Correlation |
---|
There is one clinical trial.
COVID-19 is impacting on health systems in Brazil and worldwide. Reducing the risk of clinical deterioration and prolonged disease duration in hospitalized patients with COVID-19 may alleviate the burden caused by the pandemic. Melatonin (N-acetyl-5-methoxytryptamine) has demonstrated antiapoptotic, antioxidative, and anti-inflammatory roles and has been suggested as a potential protector against organ injuries and even mediate lower mortality rates after polymicrobial sepsis in animal models. Melatonin agonists may modulate protective effects against acute lung injury and play a clinical role in individuals with SARS-CoV-2 infection. The investigators proposed a clinical trial testing the effects of ramelteon 8mg in hospitalized patients with COVID-19.
Description: Defined as a National Early Warning Score 2 (NEWS2) of 0 maintained for 24 hours [Time Frame: Assessed daily (enrollment is day 0)] The NEWS consists of a simple aggregate scoring system based on physiological measurements, regularly registered in inpatient settings, including six parameters: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, and temperature.
Measure: Time to resolution of symptoms [National Early Warning Score 2 (NEWS2) of 0] Time: enrollment is day 0Description: Critical COVID-19 illness as a composite of admission to the intensive care unit (ICU), invasive ventilation, or death
Measure: Clinical worsening to critical COVID-19 illness Time: until Day 30Description: Measured by duration of use of supplemental oxygen (if applicable)
Measure: Duration of supplemental oxygen therapy Time: until day 14Description: Measured by duration of use of mechanical ventilation
Measure: Duration of mechanical ventilation (if applicable) Time: until day 30Description: Measured by duration of hospitalization
Measure: Duration of hospitalisation Time: until day 30Description: Presence or absence of SARS-CoV-2 Viral RNA in nasopharyngeal swab or lower respiratory secretions
Measure: Proportion of participants with virologic clearance in nasopharyngeal swab RT-PCR Time: Day 14Description: Reduction of C-reactive protein levels > 50% in comparison with PCR levels at the admission
Measure: C-reactive protein (CRP) level's reduction Time: Days 3, 5 and 8Description: Incidence of new onset lymphopenia during hospitalization measured by blood draw
Measure: Incidence of New Onset Lymphopenia Time: Through study completion, average of 15 daysDescription: Reduction of mean direct bilirubin levels in comparison with levels at the admission
Measure: Direct bilirubin level's reduction Time: Measured in study Days 3, 5, and 8Description: Differences in number of patients in study arms who experienced side effects
Measure: Side Effects Time: until day 14