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

Primary Purpose

Covid19, SARS-CoV 2, Coronavirus Infection

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Melatonin 2mg

Placebo oral tablet

About this trial

This is an interventional prevention trial for Covid19 focused on measuring melatonin, prevention, covid19, Sars-CoV2, healthcare

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

2 mg of melatonin orally before bedtime for 12 weeks

Identically looking placebo orally before bedtime for 12 weeks

Outcomes

Primary Outcome Measures

SARS-CoV 2 infection rate

Number of confirmed (positive CRP) symptomatic infections in each treatment group

Secondary Outcome Measures

Full Information

NCT ID

NCT04353128

First Posted

April 16, 2020

Last Updated

November 22, 2021

Sponsor

Instituto de Investigación Hospital Universitario La Paz

1. Study Identification

Unique Protocol Identification Number

NCT04353128

Brief Title

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

Acronym

MeCOVID

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

April 20, 2020 (Actual)

Primary Completion Date

October 1, 2020 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto de Investigación Hospital Universitario La Paz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, SARS-CoV 2, Coronavirus Infection

Keywords

melatonin, prevention, covid19, Sars-CoV2, healthcare

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

450 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Melatonin

Arm Type

Experimental

Arm Description

2 mg of melatonin orally before bedtime for 12 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Identically looking placebo orally before bedtime for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Melatonin 2mg

Other Intervention Name(s)

circadin 2 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Other Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

SARS-CoV 2 infection rate

Description

Number of confirmed (positive CRP) symptomatic infections in each treatment group

Time Frame

up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: