drugset / Trial / NCT04568863
Efficacy of Intravenous Melatonin on Mortality in Adult Patients Admitted to the Intensive Care Unit With COVID-19
Phase 2
Completed
18 enrolled
Pharmamel S.L.
Hospital Universitario La Paz · collabInstituto de Investigación Hospital Universitario La Paz · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2020-06-20
- Primary completion
- 2020-11-30
- Completion
- 2020-11-30
Publications
- Background Rodriguez-Rubio M, Figueira JC, Acuna-Castroviejo D, Borobia AM, Escames G, de la Oliva P. A phase II, single-center, double-blind, randomized placebo-controlled trial to explore the efficacy and safety of intravenous melatonin in patients with COVID-19 admitted to the intensive care unit (MelCOVID study): a structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Aug 5;21(1):699. doi: 10.1186/s13063-020-04632-4.
- Background Acuna-Castroviejo D, Escames G, Figueira JC, de la Oliva P, Borobia AM, Acuna-Fernandez C. Clinical trial to test the efficacy of melatonin in COVID-19. J Pineal Res. 2020 Oct;69(3):e12683. doi: 10.1111/jpi.12683. Epub 2020 Aug 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 5 mg/kg | Intravenous |