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

NCT04353128 | Completed Phase 2 DMC

• 1 other identifier: MeCOVID
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV 2; Coronavirus Infection

Keywords

melatonin; prevention; covid19; Sars-CoV2; healthcare

Outcome Measures

Primary Outcomes (1)

• SARS-CoV 2 infection rate

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

  up to 12 weeks

Study Arms (2)

Melatonin

EXPERIMENTAL

2 mg of melatonin orally before bedtime for 12 weeks

Drug: Melatonin 2mg

Placebo

PLACEBO COMPARATOR

Identically looking placebo orally before bedtime for 12 weeks

Drug: Placebo oral tablet

Interventions

Melatonin 2mg DRUG

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

Also known as: circadin 2 mg

Melatonin

Placebo oral tablet DRUG

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (9)

• Lee PI, Hu YL, Chen PY, Huang YC, Hsueh PR. Are children less susceptible to COVID-19? J Microbiol Immunol Infect. 2020 Jun;53(3):371-372. doi: 10.1016/j.jmii.2020.02.011. Epub 2020 Feb 25. No abstract available.

  PMID: 32147409 BACKGROUND

• Lu X, Zhang L, Du H, Zhang J, Li YY, Qu J, Zhang W, Wang Y, Bao S, Li Y, Wu C, Liu H, Liu D, Shao J, Peng X, Yang Y, Liu Z, Xiang Y, Zhang F, Silva RM, Pinkerton KE, Shen K, Xiao H, Xu S, Wong GWK; Chinese Pediatric Novel Coronavirus Study Team. SARS-CoV-2 Infection in Children. N Engl J Med. 2020 Apr 23;382(17):1663-1665. doi: 10.1056/NEJMc2005073. Epub 2020 Mar 18. No abstract available.

  PMID: 32187458 BACKGROUND

• Scholtens RM, van Munster BC, van Kempen MF, de Rooij SE. Physiological melatonin levels in healthy older people: A systematic review. J Psychosom Res. 2016 Jul;86:20-7. doi: 10.1016/j.jpsychores.2016.05.005. Epub 2016 May 10.

  PMID: 27302542 BACKGROUND

• Gunn PJ, Middleton B, Davies SK, Revell VL, Skene DJ. Sex differences in the circadian profiles of melatonin and cortisol in plasma and urine matrices under constant routine conditions. Chronobiol Int. 2016;33(1):39-50. doi: 10.3109/07420528.2015.1112396. Epub 2016 Jan 5.

  PMID: 26731571 BACKGROUND

• Zhang R, Wang X, Ni L, Di X, Ma B, Niu S, Liu C, Reiter RJ. COVID-19: Melatonin as a potential adjuvant treatment. Life Sci. 2020 Jun 1;250:117583. doi: 10.1016/j.lfs.2020.117583. Epub 2020 Mar 23.

  PMID: 32217117 BACKGROUND

• Tan DX, Korkmaz A, Reiter RJ, Manchester LC. Ebola virus disease: potential use of melatonin as a treatment. J Pineal Res. 2014 Nov;57(4):381-4. doi: 10.1111/jpi.12186. Epub 2014 Oct 14.

  PMID: 25262626 BACKGROUND

• Ran L, Chen X, Wang Y, Wu W, Zhang L, Tan X. Risk Factors of Healthcare Workers With Coronavirus Disease 2019: A Retrospective Cohort Study in a Designated Hospital of Wuhan in China. Clin Infect Dis. 2020 Nov 19;71(16):2218-2221. doi: 10.1093/cid/ciaa287.

  PMID: 32179890 BACKGROUND

• Gooneratne NS, Edwards AY, Zhou C, Cuellar N, Grandner MA, Barrett JS. Melatonin pharmacokinetics following two different oral surge-sustained release doses in older adults. J Pineal Res. 2012 May;52(4):437-45. doi: 10.1111/j.1600-079X.2011.00958.x. Epub 2012 Feb 21.

  PMID: 22348451 BACKGROUND

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: April 20, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 23, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)