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

NCT04470297 | Unknown Phase 2 DMC

• 1 other identifier: MELCOV2020
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19; Lung Injury

Keywords

COVID-19; Acute Distress Respiratory Syndrome; Melatonin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Clinical worsening to critical COVID-19 illness

  until Day 30

• Duration of supplemental oxygen therapy

  until day 14

• Duration of mechanical ventilation (if applicable)

  until day 30

• Duration of hospitalisation

  until day 30

• Proportion of participants with virologic clearance in nasopharyngeal swab RT-PCR

  Day 14

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Ramelteon

EXPERIMENTAL

A pill containing ramelteon 8mg will be administered daily at bedtime for 10 days.

Drug: Ramelteon 8mg

Interventions

Ramelteon 8mg DRUG

Standard care combined with oral placebo or ramelteon 8mg at bedtime for 10 days

Placebo; Ramelteon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals (or legally authorized representative) providing written informed consent prior to initiation of any study procedures.
• Male or non-pregnant female adult ≥18 years of age at time of enrollment
• Subject consents to randomization within 48 hours of hospital admission
• Symptom duration of 14 days or less upon recruitment
• At least one of the following:
• Radiographic infiltrates by imaging (chest x-ray or CT scan), OR
• Clinical assessment (evidence of rales/crackles on the exam) AND SpO2 ≤ 94% on room air

You may not qualify if:

• Mild COVID-19 disease (minor clinical symptoms, imaging does not show signs of lung inflammation)
• Recent history of or any in-hospital exposure to investigational medications targeting COVID-19
• ALT/AST \> 5 times the upper limit of normal.
• Known hypersensitivity to ramelteon
• Pregnancy
• Severe hepatic insufficiency
• Fluvoxamine use

Sponsors & Collaborators

• Associação Fundo de Incentivo à Pesquisa: lead

MeSH Terms

Conditions

COVID-19; Lung Injury; Respiratory Distress Syndrome

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Respiration Disorders

Study Officials

• Dalva Poyares, PhD

  Associação Fundo de Incentivo a Pesquisa

  STUDY DIRECTOR

Central Study Contacts

Ronaldo D Piovezan, PhD

CONTACT

+5511984153364; rdpiovezan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 14, 2020
• Study Start: September 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: March 1, 2021
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF