This study is a multi-center randomized, controlled, and blinded clinical trial study that will be performed in four medical-educational centers. In this study, the samples will be selected from among patients with SARS-CoV-2 as easy access and based on entry criteria and will be randomly divided into two groups, including a control group and an intervention group. The study will be conducted in four medical centers. From each center, 56 definitive Corona patients will be selected, who will be randomly divided into two groups of 28, for a total of 224 patients will enter the study. In the intervention group, in addition to receiving the test spray, Patients will also receive standard treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
224
One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.
participants will receive a placebo spray every hour. This process will continue for 10 days.
: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days
Mohammad Sadegh Bagheri Baghdasht
Tehran, Iran
RECRUITINGDyspnea
shortness of breath measured by Visual analog scale (VAS) dyspnea score. The minimum score is zero means shortness of breath and the highest score is 10 means the maximum intensity of shortness of breath.
Time frame: up to 14 days
long of hospitalization
The length of time the patient is hospitalized after the diagnosis of COVID-19
Time frame: up to 28 days
Radiological Treatment Response
CT scans help determine how much the lungs are affected by COVID-19.
Time frame: up to 14 days
Mortality
In-hospital mortality
Time frame: Up to 28 days
Allergic drug
There will be known allergic reactions to the drugs.
Time frame: up to 14 days
Laboratory Treatment Response
Normal blood cell count and CRP count (normal laboratory range)
Time frame: up to 14 days
O2 saturation without supplemental oxygen
Using an oximeter pulse, the amount of oxygen saturation is measured. If the patient is receiving oxygen, first cut off the oxygen for 5 minutes and then measure. If the oxygen drops below 90 degrees, oxygen therapy will be re-established immediately.
Time frame: up to 14 days
drug reactions Adverse
Complications in both groups should be evaluated and evaluated during treatment. 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 14 days
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