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AzTrials

Covid19Phase 2/3MeCOVIDNCT04353128

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

A Phase 2/3 study testing Melatonin 2mg in people with Covid19 and SARS-CoV 2, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Covid19, SARS-CoV 2, Coronavirus Infection
What is being tested?
Melatonin 2mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
1 siteSpain
Study dates
20 Apr 2020to 1 Dec 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • HIV infection
  • Active hepatitis B infection
  • Renal failure (CrCl < 60 mL/min/1.73 m2) or need for hemodialysis
  • Osteoporosis
  • Myasthenia gravis
  • Retinitis pigmentosa
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Melatonin 2mg, Placebo oral tablet
Keywords
melatonin, prevention, covid19, Sars-CoV2, healthcare
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Melatonin 2mgDrug

    Also called circadin 2 mg

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

  • Placebo oral tabletDrug

    Also called Placebo

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

Study groups in NCT04353128
Study groupRoleWhat they receive
MelatoninExperimental2 mg of melatonin orally before bedtime for 12 weeks
Receives: Drug: Melatonin 2mg
PlaceboPlacebo comparatorIdentically looking placebo orally before bedtime for 12 weeks
Receives: Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SARS-CoV 2 infection rate

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

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2020
  2. Study start20 Apr 2020
  3. Primary completion1 Oct 2020
  4. Study completion1 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353128
Sponsor's protocol ID
MeCOVID
Acronym
MeCOVID
Status last verified
Apr 2020
First submitted
16 Apr 2020
Last updated
23 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32147409

  • 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.

    PubMed 32187458

  • 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.

    PubMed 27302542

  • 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.

    PubMed 26731571

  • 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.

    PubMed 32217117

  • 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.

    PubMed 25262626

  • 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.

    PubMed 32179890

  • 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.

    PubMed 22348451

  • 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.

    PubMed 32091533

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Melatonin 2mg in people with Covid19 and SARS-CoV 2, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARS-CoV 2 infection rate (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04353128, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.

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