Status:
COMPLETED
Efficacy of Melatonin in the Prophylaxis of Coronavirus Disease 2019 (COVID-19) Among Healthcare Workers.
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Conditions:
Covid19
SARS-CoV 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
There is an urgent need to evaluate interventions that can prevent the infection with SARS-CoV 2 of healthcare workers at risk. Melatonin is an inexpensive and safe product with protective effect in b...
Detailed 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 w...
Eligibility Criteria
Inclusion
- Healthcare workers from the public and private Spanish hospital network at risk of SARS-CoV 2 infection
- Not having a previous COVID19 diagnosis
- Not having experienced COVID19 symptoms from March 1st 2020 until randomization
- Understanding the purpose of the trial and not having taken any pre-exposure prophylaxis (PrEP) including HIV PrEP from March 1st 2020 until randomization
- Having a negative SARS-CoV 2 CRP before randomization
- Having a negative urinary pregnancy test in the previous 7 days for premenopausal women
- Premenopausal women and males with premenopausal couples must commit to using a high efficiency anticonceptive method
Exclusion
- HIV infection
- Active hepatitis B infection
- Renal failure (CrCl \< 60 mL/min/1.73 m2) or need for hemodialysis
- Osteoporosis
- Myasthenia gravis
- Retinitis pigmentosa
- Bradycardia (less than 50 bpm)
- Weight less than 40 Kg
- Treatment with drugs that prolong the QT interval for more than 7 days in the last month before randomization including: azithromycin, cisapride, methadone, droperidol, sotalol, quinidine, clarithromycin, haloperidol...
- Hereditary intolerance to galactose, Lapp lactase deficiency or glucose or galactose malabsorption
- Treatment with fluvoxamine
- Treatment with benzodiazepines or benzodiazepine analogues such as zolpidem, zopiclone or zaleplon
- Pregnancy
- Breastfeeding
- History of potentially immune derived diseases such as: lupus, Crohn's disease, ulcerative colitis, vasculitis or rheumatoid arthritis
- Insulin-dependent diabetes mellitus
- Known history of hypersensitivity to the study drug or any of its components
- Patients that should not be included in the study at the judgment of the research team
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04353128
Start Date
April 20 2020
End Date
December 1 2020
Last Update
November 23 2021
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Spain, 28046