NCT04409522

Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Mohammad Sadegh Bagheri Baghdasht · Academic / Other
• Sex: All
• Age: 16 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The leading cause of death in patients with COVID19 is a severe inflammatory response caused by a cytokine storm that results in acute respiratory distress syndrome and acute pulmonary insufficiency, as well as dysfunction of several vital organs. Therefore, preventing the occurrence of uncontrolled inflammation is the main goal of the ongoing clinical trials. Chloroquine and tocilizumab, which have the best results, are also prescribed to control inflammation. But it can be said that treatments are the main source of inflammation. Inflammasome NLRP3 is one of the mechanisms involved in many severe inflammatory disorders. Inflammatory activation has already been demonstrated by many viruses. Melatonin, on the other hand, is a hormone in the body that can inhibit Inflammation NLRP3 in addition to various anti-inflammatory effects, especially after severe inflammation. Older adults with lower levels of melatonin and children with maximum levels of melatonin are the risk groups and low-risk groups for the disease, respectively. In the present study, while measuring melatonin in patients with COVID19, its effectiveness as a treatment method along with the common antiviral drug regimen in patients with severe disease will be evaluated.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Melatonin	Participants in this group, in addition to receiving the usual treatment of COVID-19, will receive a 9 mg dose of melatonin for seven to ten nights.
DRUG	The usual treatment	Participants in this group will receive the usual treatment of COVID-19

Timeline

• Start date: 2020-05-12
• Primary completion: 2020-06-05
• Completion: 2020-09-25
• First posted: 2020-06-01
• Last updated: 2020-06-01

Locations

1 site across 1 country: Iran