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

Mohammad Sadegh Bagheri Baghdasht

Status: Unknown

Conditions: COVID-19

Treatments: Drug: The usual treatment; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT04409522

IR.BMSU.REC.1399.039

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 16 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups

Test Group

Experimental group

Description:

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.

Treatment:

Drug: Melatonin

Drug: The usual treatment

Control Group

Active Comparator group

Description:

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

Treatment:

Drug: The usual treatment