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

NCT04409522 | Unknown DMC

• 1 other identifier: IR.BMSU.REC.1399.039
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Melatonin

  Immune system modulator. The amount of it is determined by laboratory methods

  up to 10 days

Secondary Outcomes (7)

• Inflammatory cytokines

  up to 10 days

• C-reactive protein (CRP)

  up to 10 days

• Cough

  up to 10 days

• Oxygen saturation of the blood

  up to 10 days

• ESR

  up to 10 days

Study Arms (2)

Test Group

EXPERIMENTAL

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; Drug: The usual treatment

Control Group

ACTIVE COMPARATOR

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

Drug: The usual treatment

Interventions

Melatonin 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.

Test Group

The usual treatment DRUG

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

Control Group; Test Group

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient dissatisfaction
• Existence of drug interactions
• Lack of proper conditions for receiving medication

Sponsors & Collaborators

• Mohammad Sadegh Bagheri Baghdasht: lead

Study Sites (1)

Mohammad Sadegh Bagheri Baghdasht

Tehran, 0, Iran

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Mohammad Sadegh Bagheri Baghdasht

CONTACT

0098 9356318204; sadegh.bagheri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 1, 2020
• Study Start: May 12, 2020
• Primary Completion: June 5, 2020
• Study Completion: September 25, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

IR (1)