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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Melatonin
The usual treatment
Sponsored by
Mohammad Sadegh Bagheri Baghdasht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

16 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mohammad Sadegh Bagheri BaghdashtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Group

Control Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
C-reactive protein (CRP)
C-reactive protein (CRP) is a protein made by the liver that measured by serological or analyzer method
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.
Oxygen saturation of the blood
Oxygen saturation of the blood will measure by pulse oximeter
ESR
Red blood cell sedimentation rate will measure by Autoanalyzer
Radiological Treatment Response
Radiological Treatment Response (CT scan), more than 50% reduction in the affected area
Inflammatory route
Cellular pathway active in inflammation

Full Information

First Posted
May 28, 2020
Last Updated
May 28, 2020
Sponsor
Mohammad Sadegh Bagheri Baghdasht
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1. Study Identification

Unique Protocol Identification Number
NCT04409522
Brief Title
Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients
Official Title
Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
June 5, 2020 (Anticipated)
Study Completion Date
September 25, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohammad Sadegh Bagheri Baghdasht

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants in this group will receive the usual treatment of COVID-19
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
The usual treatment
Intervention Description
Participants in this group will receive the usual treatment of COVID-19
Primary Outcome Measure Information:
Title
Melatonin
Description
Immune system modulator. The amount of it is determined by laboratory methods
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
Inflammatory cytokines
Description
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
Time Frame
up to 10 days
Title
C-reactive protein (CRP)
Description
C-reactive protein (CRP) is a protein made by the liver that measured by serological or analyzer method
Time Frame
up to 10 days
Title
Cough
Description
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.
Time Frame
up to 10 days
Title
Oxygen saturation of the blood
Description
Oxygen saturation of the blood will measure by pulse oximeter
Time Frame
up to 10 days
Title
ESR
Description
Red blood cell sedimentation rate will measure by Autoanalyzer
Time Frame
up to 10 days
Title
Radiological Treatment Response
Description
Radiological Treatment Response (CT scan), more than 50% reduction in the affected area
Time Frame
up to 10 days
Title
Inflammatory route
Description
Cellular pathway active in inflammation
Time Frame
up to 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Sadegh Bagheri Baghdasht
Phone
0098 9356318204
Email
sadegh.bagheri@gmail.com
Facility Information:
Facility Name
Mohammad Sadegh Bagheri Baghdasht
City
Tehran
ZIP/Postal Code
0
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Sadegh Bagheri Baghdasht

12. IPD Sharing Statement

Learn more about this trial

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

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