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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04409522
• Other study ID #: IR.BMSU.REC.1399.039
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: September 25, 2020

Study information

• Verified date: May 2020
• Source: Baqiyatallah Medical Sciences University
• Contact: Mohammad Sadegh Bagheri Baghdasht
• Phone: 0098 9356318204
• Email: sadegh.bagheri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: September 25, 2020
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

Inclusion Criteria:

• Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19

• Oxygen saturation drop below 93%

• Systolic blood pressure drop below 100 or blood pressure drop of 30 mm Hg from the patient's previous normal systolic blood pressure

• Fever

• Dry cough

• Positive PCR for COVID-19

• Laboratory indices include CRP and ESR indicating COVID-19

Exclusion Criteria:

• Patient dissatisfaction

• Existence of drug interactions

• Lack of proper conditions for receiving medication

Related Conditions & MeSH terms

• COVID-19

Intervention

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.
• The usual treatment
Participants in this group will receive the usual treatment of COVID-19

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mohammad Sadegh Bagheri Baghdasht	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Mohammad Sadegh Bagheri Baghdasht

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melatonin	Immune system modulator. The amount of it is determined by laboratory methods	up to 10 days
Secondary	Inflammatory cytokines	is a type of signaling molecule (a cytokine) that is secreted from immune cells like helper T cells (Th) and macrophages, and certain other cell types that promote inflammation which is measured by serological or analyzer method	up to 10 days
Secondary	C-reactive protein (CRP)	C-reactive protein (CRP) is a protein made by the liver that measured by serological or analyzer method	up to 10 days
Secondary	Cough	A sudden, audible expulsion of air from the lungs through a partially closed glottis, preceded by inhalation. It is a protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions that measured by Physical examination.	up to 10 days
Secondary	Oxygen saturation of the blood	Oxygen saturation of the blood will measure by pulse oximeter	up to 10 days
Secondary	ESR	Red blood cell sedimentation rate will measure by Autoanalyzer	up to 10 days
Secondary	Radiological Treatment Response	Radiological Treatment Response (CT scan), more than 50% reduction in the affected area	up to 10 days
Secondary	Inflammatory route	Cellular pathway active in inflammation	up to 10 days