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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04409522
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Melatonin Drug: The usual treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients
Actual Study Start Date : May 12, 2020
Estimated Primary Completion Date : June 5, 2020
Estimated Study Completion Date : September 25, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

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




Primary Outcome Measures :
  1. Melatonin [ Time Frame: up to 10 days ]
    Immune system modulator. The amount of it is determined by laboratory methods


Secondary Outcome Measures :
  1. Inflammatory cytokines [ Time Frame: up to 10 days ]
    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

  2. C-reactive protein (CRP) [ Time Frame: up to 10 days ]
    C-reactive protein (CRP) is a protein made by the liver that measured by serological or analyzer method

  3. Cough [ Time Frame: up to 10 days ]
    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.

  4. Oxygen saturation of the blood [ Time Frame: up to 10 days ]
    Oxygen saturation of the blood will measure by pulse oximeter

  5. ESR [ Time Frame: up to 10 days ]
    Red blood cell sedimentation rate will measure by Autoanalyzer

  6. Radiological Treatment Response [ Time Frame: up to 10 days ]
    Radiological Treatment Response (CT scan), more than 50% reduction in the affected area

  7. Inflammatory route [ Time Frame: up to 10 days ]
    Cellular pathway active in inflammation



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409522


Contacts
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Contact: Mohammad Sadegh Bagheri Baghdasht 0098 9356318204 sadegh.bagheri@gmail.com

Locations
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Iran, Islamic Republic of
Mohammad Sadegh Bagheri Baghdasht Recruiting
Tehran, Iran, Islamic Republic of, 0
Contact: Mohammad Sadegh Bagheri Baghdasht         
Sponsors and Collaborators
Mohammad Sadegh Bagheri Baghdasht
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Responsible Party: Mohammad Sadegh Bagheri Baghdasht, Principal Investigator, Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier: NCT04409522    
Other Study ID Numbers: IR.BMSU.REC.1399.039
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants