Covid19 Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | March 2021 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Individuals (or legally authorized representative) providing written informed consent prior to initiation of any study procedures. 2. Male or non-pregnant female adult =18 years of age at time of enrollment 3. Subject consents to randomization within 48 hours of hospital admission 4. Symptom duration of 14 days or less upon recruitment 5. At least one of the following: 1. Radiographic infiltrates by imaging (chest x-ray or CT scan), OR 2. Clinical assessment (evidence of rales/crackles on the exam) AND SpO2 = 94% on room air Exclusion Criteria: 1. Mild COVID-19 disease (minor clinical symptoms, imaging does not show signs of lung inflammation) 2. Recent history of or any in-hospital exposure to investigational medications targeting COVID-19 3. ALT/AST > 5 times the upper limit of normal. 4. Known hypersensitivity to ramelteon 5. Pregnancy 6. Severe hepatic insufficiency 7. Fluvoxamine use |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Associação Fundo de Incentivo à Pesquisa |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to resolution of symptoms [National Early Warning Score 2 (NEWS2) of 0] | 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. | enrollment is day 0 | |
Secondary | Clinical worsening to critical COVID-19 illness | Critical COVID-19 illness as a composite of admission to the intensive care unit (ICU), invasive ventilation, or death | until Day 30 | |
Secondary | Duration of supplemental oxygen therapy | Measured by duration of use of supplemental oxygen (if applicable) | until day 14 | |
Secondary | Duration of mechanical ventilation (if applicable) | Measured by duration of use of mechanical ventilation | until day 30 | |
Secondary | Duration of hospitalisation | Measured by duration of hospitalization | until day 30 | |
Secondary | Proportion of participants with virologic clearance in nasopharyngeal swab RT-PCR | Presence or absence of SARS-CoV-2 Viral RNA in nasopharyngeal swab or lower respiratory secretions | Day 14 | |
Secondary | C-reactive protein (CRP) level's reduction | Reduction of C-reactive protein levels > 50% in comparison with PCR levels at the admission | Days 3, 5 and 8 | |
Secondary | Incidence of New Onset Lymphopenia | Incidence of new onset lymphopenia during hospitalization measured by blood draw | Through study completion, average of 15 days | |
Secondary | Direct bilirubin level's reduction | Reduction of mean direct bilirubin levels in comparison with levels at the admission | Measured in study Days 3, 5, and 8 | |
Secondary | Side Effects | Differences in number of patients in study arms who experienced side effects | until day 14 |
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