Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19
- Conditions
- COVID-19
- Interventions
- Drug: PHR160 SprayDrug: PlaceboDrug: Standard treatment
- Registration Number
- NCT04463420
- Lead Sponsor
- Baqiyatallah Medical Sciences University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 224
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Group PHR160 Spray Intervention group: : 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 / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days. Test Group Standard treatment Intervention group: : 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 / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days. Control Group Placebo Control group: 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 Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days Control Group Standard treatment Control group: 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 Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Mortality Up to 28 days In-hospital mortality
Laboratory Treatment Response up to 14 days Normal blood cell count and CRP count (normal laboratory range)
long of hospitalization up to 28 days The length of time the patient is hospitalized after the diagnosis of COVID-19
Radiological Treatment Response up to 14 days CT scans help determine how much the lungs are affected by 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.Allergic drug up to 14 days There will be known allergic reactions to the drugs.
Trial Locations
- Locations (1)
Mohammad Sadegh Bagheri Baghdasht
🇮🇷Tehran, Iran, Islamic Republic of