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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04353128
Recruitment Status : Not yet recruiting
First Posted : April 20, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. SARS-CoV 2 infection rate [ Time Frame: up to 12 weeks ]
    Number of confirmed (positive CRP) symptomatic infections in each treatment group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, quinidin, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353128


Contacts
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Contact: Alberto M Borobia, MD, PhD +34912071466 alberto.borobia@salud.madrid.org

Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
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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:

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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT04353128    
Other Study ID Numbers: MeCOVID
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
melatonin
prevention
covid19
Sars-CoV2
healthcare
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants