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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: Melatonin; Drug: The usual treatment

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Mohammad Sadegh Bagheri Baghdasht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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
ACTIVE_COMPARATOR: Control Group; Participants in this group will receive the usual treatment of COVID-19	Drug: The usual treatment; Participants in this group will receive the usual treatment of COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melatonin	Immune system modulator. The amount of it is determined by laboratory methods	up to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Oxygen saturation of the blood	Oxygen saturation of the blood will measure by pulse oximeter	up to 10 days
ESR	Red blood cell sedimentation rate will measure by Autoanalyzer	up to 10 days
Radiological Treatment Response	Radiological Treatment Response (CT scan), more than 50% reduction in the affected area	up to 10 days
Inflammatory route	Cellular pathway active in inflammation	up to 10 days

Collaborators and Investigators

• Sponsor: Mohammad Sadegh Bagheri Baghdasht

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 12, 2020
• Primary Completion (ANTICIPATED): June 5, 2020
• Study Completion (ANTICIPATED): September 25, 2020

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (ACTUAL): June 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: IR.BMSU.REC.1399.039

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No