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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-12

Study Completion Date

2020-09-25

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Test Group

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.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

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

Intervention Type DRUG

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

Control Group

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

Group Type ACTIVE_COMPARATOR

The usual treatment

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

The usual treatment

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

Intervention Type DRUG

Eligibility Criteria

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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