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Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19

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ClinicalTrials.gov Identifier: NCT04470297
Recruitment Status : Not yet recruiting
First Posted : July 14, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Ronaldo Delmonte Piovezan, Associação Fundo de Incentivo à Pesquisa

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid19 Lung Injury Drug: Ramelteon 8mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Adjuvant Therapeutic Effects of Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Placebo Comparator: Placebo
A placebo with the same physical characteristics of the experimental drug pill will be administered at the same time and daily schedule as the experimental intervention for 10 days.
Drug: Ramelteon 8mg
Standard care combined with oral placebo or ramelteon 8mg at bedtime for 10 days

Experimental: Ramelteon
A pill containing ramelteon 8mg will be administered daily at bedtime for 10 days.
Drug: Ramelteon 8mg
Standard care combined with oral placebo or ramelteon 8mg at bedtime for 10 days




Primary Outcome Measures :
  1. Time to resolution of symptoms [National Early Warning Score 2 (NEWS2) of 0] [ Time Frame: enrollment is day 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.


Secondary Outcome Measures :
  1. Clinical worsening to critical COVID-19 illness [ Time Frame: until Day 30 ]
    Critical COVID-19 illness as a composite of admission to the intensive care unit (ICU), invasive ventilation, or death

  2. Duration of supplemental oxygen therapy [ Time Frame: until day 14 ]
    Measured by duration of use of supplemental oxygen (if applicable)

  3. Duration of mechanical ventilation (if applicable) [ Time Frame: until day 30 ]
    Measured by duration of use of mechanical ventilation

  4. Duration of hospitalisation [ Time Frame: until day 30 ]
    Measured by duration of hospitalization

  5. Proportion of participants with virologic clearance in nasopharyngeal swab RT-PCR [ Time Frame: Day 14 ]
    Presence or absence of SARS-CoV-2 Viral RNA in nasopharyngeal swab or lower respiratory secretions

  6. C-reactive protein (CRP) level's reduction [ Time Frame: Days 3, 5 and 8 ]
    Reduction of C-reactive protein levels > 50% in comparison with PCR levels at the admission

  7. Incidence of New Onset Lymphopenia [ Time Frame: Through study completion, average of 15 days ]
    Incidence of new onset lymphopenia during hospitalization measured by blood draw

  8. Direct bilirubin level's reduction [ Time Frame: Measured in study Days 3, 5, and 8 ]
    Reduction of mean direct bilirubin levels in comparison with levels at the admission

  9. Side Effects [ Time Frame: until day 14 ]
    Differences in number of patients in study arms who experienced side effects



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470297


Contacts
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Contact: Ronaldo D Piovezan, PhD +5511984153364 rdpiovezan@gmail.com

Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
Investigators
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Study Director: Dalva Poyares, PhD Associação Fundo de Incentivo a Pesquisa
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Responsible Party: Ronaldo Delmonte Piovezan, PhD, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier: NCT04470297    
Other Study ID Numbers: MELCOV2020
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ronaldo Delmonte Piovezan, Associação Fundo de Incentivo à Pesquisa:
COVID-19
Acute Distress Respiratory Syndrome
Melatonin
Additional relevant MeSH terms:
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Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries