Efficacy of Melatonin in the Prophylaxis of Coronavirus Disease 2019 (COVID-19) Among Healthcare Workers.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronavirus Infection
- COVID-19
- Sars Cov 2
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
Healthcare workers are at an increased risk of acquiring COVID-19 due to an increased exposure to the virus and global personal protective equipment shortages. Preventing the infection of healthcare workers is critical the current epidemic situation when healthcare systems are under extreme pressure...
Healthcare workers are at an increased risk of acquiring COVID-19 due to an increased exposure to the virus and global personal protective equipment shortages. Preventing the infection of healthcare workers is critical the current epidemic situation when healthcare systems are under extreme pressure. There is a lack of evidence surrounding potential preventive strategies to decrease the incidence of COVID-19 among healthcare workers. Melatonin, an endogenous hormone involved in circadian rhythm control, is an inexpensive and safe product that has shown protective effects in bacterial and viral infections likely due to its anti-inflammatory and anti-oxidative effects. SARS-CoV 2 seems to relatively spare younger children and those who are infected develop the severe forms of the disease very rarely. Peak melatonin serum levels are higher in younger children and decrease with age. These levels are also higher in women, specially during pregnancy, who also seem to be less affected by the virus when compared to men. The investigators hypothesize that elevating peak melatonin levels to a range similar to that of children by administering 2 mg of melatonin daily might prevent the infection with SARS-CoV 2 among exposed healthcare workers. The investigators also hypothesize that among those who develop the disease melatonin might prevent the more severe forms.
Tracking Information
- NCT #
- NCT04353128
- Collaborators
- Not Provided
- Investigators
- Study Chair: Pedro de la Oliva, MD, PhD Hospital Universitario La Paz Study Chair: Antonio J Carcas Hospital Universitario La Paz Study Chair: Irene García García Hospital Universitario La Paz Study Chair: Amelia Rodríguez Mariblanca Hospital Universitario La Paz Study Chair: Lucía Martínez de Soto Hospital Universitario La Paz Study Chair: María J Rosales Hospital Universitario La Paz Study Chair: José R Arribas Hospital Universitario La Paz Study Chair: Juan González Hospital Universitario La Paz Study Chair: Alberto M Borobia, MD, PhD Hospital Universitario La Paz Study Chair: Miguel Rodriguez-Rubio, MD Hospital Universitario La Paz