Status:
UNKNOWN
Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19
Lead Sponsor:
Associação Fundo de Incentivo à Pesquisa
Conditions:
Covid19
Lung Injury
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 bur...
Detailed Description
The severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) pandemic, also denominated Coronavirus Disease 2019 (COVID-19), is currently challenging health systems in Brazil and worldwide. The mo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04470297
Start Date
September 1 2020
End Date
March 1 2021
Last Update
July 24 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.