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Efficacy of Intravenous Melatonin on Mortality in Adult Patients Admitted to the Intensive Care Unit With COVID-19

NCT04568863 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-03-18

No results posted yet for this study

Summary

There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in Covid-19 patients in the ICUs.

Conditions

  • COVID-19
  • SARS-CoV 2
  • Coronavirus Infection

Interventions

DRUG

Melatonin intravenous

7 days of 5 mg per Kg of actual body weight per day of intravenous melatonin every 6 hours. Maximum daily dose 500 mg per day.

DRUG

Placebo intravenous

7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours.

Sponsors & Collaborators

  • Hospital Universitario La Paz

    collaborator OTHER

  • Instituto de Investigación Hospital Universitario La Paz

    collaborator OTHER

  • Pharmamel S.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-20
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04568863 on ClinicalTrials.gov