COVID-19
Conditions
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.
Interventions
DRUGMelatonin
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.
DRUGThe usual treatment
Participants in this group will receive the usual treatment of COVID-19
Sponsors
Mohammad Sadegh Bagheri Baghdasht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Melatonin | up to 10 days | Immune system modulator. The amount of it is determined by laboratory methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein (CRP) | up to 10 days | C-reactive protein (CRP) is a protein made by the liver that measured by serological or analyzer method |
| Cough | 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. |
| Oxygen saturation of the blood | up to 10 days | Oxygen saturation of the blood will measure by pulse oximeter |
| Inflammatory cytokines | 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 |
| Radiological Treatment Response | up to 10 days | Radiological Treatment Response (CT scan), more than 50% reduction in the affected area |
| Inflammatory route | up to 10 days | Cellular pathway active in inflammation |
| ESR | up to 10 days | Red blood cell sedimentation rate will measure by Autoanalyzer |
Countries
Iran
Contacts
Primary ContactMohammad Sadegh Bagheri Baghdasht
Outcome results
None listed