Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19
NCT ID: NCT04463420
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
224 participants
INTERVENTIONAL
2020-08-15
2020-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test Group
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.
PHR160 Spray
One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.
Standard 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
Control Group
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
Placebo
participants will receive a placebo spray every hour. This process will continue for 10 days.
Standard 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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PHR160 Spray
One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.
Placebo
participants will receive a placebo spray every hour. This process will continue for 10 days.
Standard 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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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)
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Baqiyatallah Medical Sciences University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohammad Sadegh Bagheri Baghdasht
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mohammad Sadegh Bagheri Baghdasht
Tehran, , Iran
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IR.BMSU.REC.1399.176
Identifier Type: -
Identifier Source: org_study_id