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

November 22, 2021 updated by: Instituto de Investigación Hospital Universitario La Paz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV 2 infection rate
Time Frame: up to 12 weeks
Number of confirmed (positive CRP) symptomatic infections in each treatment group
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MeCOVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronavirus Infection

Clinical Trials on Melatonin 2mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe