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Ramelteon 8mgWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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Correlated MeSH Terms (1)


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D055370 Lung Injury NIH 0.21

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There is one clinical trial.

Clinical Trials


1 Adjuvant Therapeutic Effects of Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19

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.

NCT04470297 Covid19 Lung Injury Drug: Ramelteon 8mg
MeSH:Lung Injury

Primary Outcomes

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 0

Secondary Outcomes

Description: 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 30

Description: Measured by duration of use of supplemental oxygen (if applicable)

Measure: Duration of supplemental oxygen therapy

Time: until day 14

Description: Measured by duration of use of mechanical ventilation

Measure: Duration of mechanical ventilation (if applicable)

Time: until day 30

Description: Measured by duration of hospitalization

Measure: Duration of hospitalisation

Time: until day 30

Description: 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 14

Description: 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 8

Description: Incidence of new onset lymphopenia during hospitalization measured by blood draw

Measure: Incidence of New Onset Lymphopenia

Time: Through study completion, average of 15 days

Description: 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 8

Description: Differences in number of patients in study arms who experienced side effects

Measure: Side Effects

Time: until day 14


No related HPO nodes (Using clinical trials)