COVID-19
Conditions
Brief summary
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
Interventions
DRUGPHR160 Spray
One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.
DRUGPlacebo
participants will receive a placebo spray every hour. This process will continue for 10 days.
DRUGStandard treatment
: 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
Sponsors
Baqiyatallah Medical Sciences University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Conscious consent to participate in the study * Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR. * Strong clinical suspicion of covid 19 with positive findings in CT Scan * Shortness of breath
Exclusion criteria
* Patients with HIV * Patients with cancer undergoing chemotherapy * Patients receiving Immune Mediators * Patients need hospitalization in the intensive care unit * Patients with uncontrolled heart, kidney or liver failure * Pregnant or lactating women * Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea | up to 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiological Treatment Response | up to 14 days | CT scans help determine how much the lungs are affected by COVID-19. |
| Mortality | Up to 28 days | In-hospital mortality |
| Allergic drug | up to 14 days | There will be known allergic reactions to the drugs. |
| long of hospitalization | up to 28 days | The length of time the patient is hospitalized after the diagnosis of COVID-19 |
| O2 saturation without supplemental oxygen | up to 14 days | 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. |
| drug reactions Adverse | Up to 14 days | 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. |
| Laboratory Treatment Response | up to 14 days | Normal blood cell count and CRP count (normal laboratory range) |
Countries
Iran
Contacts
Primary ContactMohammad Sadegh Bagheri Baghdasht
Outcome results
None listed