Efficacy of Melatonin in the Prophylaxis of Coronavirus Disease 2019 (COVID-19) Among Healthcare Workers.

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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 both bacterial and viral infections likely due to its anti-inflammatory and anti-oxidative effects. This randomized controlled trial seeks to evaluate is efficacy as a prophylaxis in healthcare workers exposed to the virus in their clinical practice.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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