COVID-19NCT04409522
Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients
A study testing Melatonin and The usual treatment in people with COVID-19, run by Mohammad Sadegh Bagheri Baghdasht at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Melatonin and The usual treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIran
- Study dates
- 12 May 2020to 25 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient dissatisfaction
- Existence of drug interactions
- Lack of proper conditions for receiving medication
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mohammad Sadegh Bagheri Baghdasht
Tehran, 0
Mohammad Sadegh Bagheri Baghdasht
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
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 treatmentDrug
Participants in this group will receive the usual treatment of COVID-19
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Melatonin; Drug: The usual treatment |
| Control Group | Active comparator | Participants in this group will receive the usual treatment of COVID-19 Receives: Drug: The usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin
Immune system modulator. The amount of it is determined by laboratory methods
Measured: up to 10 days
Secondary outcomes (7)
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
Measured: 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
Measured: 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.
Measured: up to 10 days
Oxygen saturation of the blood
Oxygen saturation of the blood will measure by pulse oximeter
Measured: up to 10 days
ESR
Red blood cell sedimentation rate will measure by Autoanalyzer
Measured: up to 10 days
Radiological Treatment Response
Radiological Treatment Response (CT scan), more than 50% reduction in the affected area
Measured: up to 10 days
Inflammatory route
Cellular pathway active in inflammation
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start12 May 2020
- Primary completion5 Jun 2020 (estimated)
- Study completion25 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammad Sadegh Bagheri Baghdasht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409522
- Sponsor's protocol ID
- IR.BMSU.REC.1399.039
- Status last verified
- May 2020
- First submitted
- 28 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients
- ClinicalTrials.gov ID
- NCT04409522
- Acronym / sponsor ID
- IR.BMSU.REC.1399.039
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Mohammad Sadegh Bagheri BaghdashtUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 5 Jun 2020 (estimated)
- Study completion
- 25 Sep 2020 (estimated)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Melatonin, Drug: The usual treatmentParticipants 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. |
| Control Group | Active comparator | Drug: The usual treatmentParticipants in this group will receive the usual treatment of COVID-19 |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Patient dissatisfaction
- Existence of drug interactions
- Lack of proper conditions for receiving medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninParticipants 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 | Test Group |
| The usual treatmentParticipants in this group will receive the usual treatment of COVID-19 | Drug | Control Group, Test Group |
Primary outcome
Melatonin
Time frame: up to 10 days
Immune system modulator. The amount of it is determined by laboratory methods
7 secondary outcomes
Inflammatory cytokines
Time frame: up to 10 days
C-reactive protein (CRP)
Time frame: up to 10 days
Cough
Time frame: up to 10 days
Oxygen saturation of the blood
Time frame: up to 10 days
ESR
Time frame: up to 10 days
Radiological Treatment Response
Time frame: up to 10 days
Inflammatory route
Time frame: up to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and The usual treatment in people with COVID-19, run by Mohammad Sadegh Bagheri Baghdasht at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Sadegh Bagheri Baghdasht (0098 9356318204, sadegh.bagheri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melatonin (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.