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

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

Interventions

DRUG

Melatonin 2mg

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

DRUG

Placebo oral tablet

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

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz

  lead OTHER

Principal Investigators

• Pedro de la Oliva, MD, PhD · Hospital Universitario La Paz

• Antonio J Carcas · Hospital Universitario La Paz

• Irene García García · Hospital Universitario La Paz

• Amelia Rodríguez Mariblanca · Hospital Universitario La Paz

• Lucía Martínez de Soto · Hospital Universitario La Paz

• María J Rosales · Hospital Universitario La Paz

• José R Arribas · Hospital Universitario La Paz

• Juan González · Hospital Universitario La Paz

• Alberto M Borobia, MD, PhD · Hospital Universitario La Paz

• Miguel Rodriguez-Rubio, MD · Hospital Universitario La Paz

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-20

Primary Completion

2020-10-01

Completion

2020-12-01

Countries

• Spain

Study Locations