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

• Status: Not yet recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Associação Fundo de Incentivo à Pesquisa
• Collaborator: Ronaldo Delmonte Piovezan, MD PhD

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