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

Sponsor

Instituto de Investigación Hospital Universitario La Paz (Other)

Overall Status

Completed

CT.gov ID

NCT04353128

Collaborator

(none)

450

Enrollment

Location

Arms

7.4

Actual Duration (Months)

60.9

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 SARS-CoV 2 Coronavirus Infection	Drug: Melatonin 2mg Drug: Placebo oral tablet	Phase 2/Phase 3

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Multicenter Randomized Controlled Trial of the Efficacy of Melatonin in the Prophylaxis of SARS-coronavirus-2 Infection Among High Risk Contacts.

Actual Study Start Date :

Apr 20, 2020

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melatonin 2 mg of melatonin orally before bedtime for 12 weeks	Drug: Melatonin 2mg 2 mg of prolonged release melatonin tablets per os (P.O.) before bedtime for 12 weeks Other Names: circadin 2 mg
Placebo Comparator: Placebo Identically looking placebo orally before bedtime for 12 weeks	Drug: Placebo oral tablet Identically looking placebo tablets P.O. before bedtime for 12 weeks Other Names: Placebo

Arm

Intervention/Treatment

Experimental: Melatonin

2 mg of melatonin orally before bedtime for 12 weeks

Drug: Melatonin 2mg

2 mg of prolonged release melatonin tablets per os (P.O.) before bedtime for 12 weeks

Other Names:

circadin 2 mg

Placebo Comparator: Placebo

Identically looking placebo orally before bedtime for 12 weeks

Drug: Placebo oral tablet

Identically looking placebo tablets P.O. before bedtime for 12 weeks

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

SARS-CoV 2 infection rate [up to 12 weeks]
Number of confirmed (positive CRP) symptomatic infections in each treatment group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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