Efficacy of Melatonin in the Prophylaxis of Coronavirus Disease 2019 (COVID-19) Among Healthcare Workers. (MeCOVID)
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| ClinicalTrials.gov Identifier: NCT04353128 |
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Recruitment Status :
Completed
First Posted : April 20, 2020
Last Update Posted : November 23, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Covid19 SARS-CoV 2 Coronavirus Infection | Drug: Melatonin 2mg Drug: Placebo oral tablet | Phase 2 Phase 3 |
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 (Clinical Trial) |
| Actual 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. |
| Actual Study Start Date : | April 20, 2020 |
| Actual Primary Completion Date : | October 1, 2020 |
| Actual Study Completion Date : | December 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Melatonin
2 mg of melatonin orally before bedtime for 12 weeks
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Drug: Melatonin 2mg
2 mg of prolonged release melatonin tablets per os (P.O.) before bedtime for 12 weeks
Other Name: circadin 2 mg |
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Placebo Comparator: Placebo
Identically looking placebo orally before bedtime for 12 weeks
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Drug: Placebo oral tablet
Identically looking placebo tablets P.O. before bedtime for 12 weeks
Other Name: Placebo |
- SARS-CoV 2 infection rate [ Time Frame: up to 12 weeks ]Number of confirmed (positive CRP) symptomatic infections in each treatment group
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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 |
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
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
| Spain | |
| Hospital Universitario La Paz | |
| Madrid, Spain, 28046 | |
| 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 |
| 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: | November 23, 2021 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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melatonin prevention covid19 Sars-CoV2 healthcare |
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Infections COVID-19 Coronavirus Infections Pneumonia, Viral Pneumonia Respiratory Tract Infections Virus Diseases Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Melatonin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |