Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19

Sponsor

Baqiyatallah Medical Sciences University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04463420

Collaborator

(none)

224

Enrollment

Location

Arms

Anticipated Duration (Months)

55.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: PHR160 Spray Drug: Placebo Drug: Standard treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

224 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19 a Multi-center Randomized Blinding Clinical Trial Study

Actual Study Start Date :

Aug 15, 2020

Anticipated Primary Completion Date :

Nov 15, 2020

Anticipated Study Completion Date :

Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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. Drug: 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
Placebo Comparator: 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	Drug: Placebo participants will receive a placebo spray every hour. This process will continue for 10 days. Drug: 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

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Drug: 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

Placebo Comparator: 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

Drug: Placebo

participants will receive a placebo spray every hour. This process will continue for 10 days.

Drug: Standard treatment

Outcome Measures

Primary Outcome Measures

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

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.
Mortality [Up to 28 days]
In-hospital mortality
Allergic drug [up to 14 days]
There will be known allergic reactions to the drugs.
Laboratory Treatment Response [up to 14 days]
Normal blood cell count and CRP count (normal laboratory range)
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mohammad Sadegh Bagheri Baghdasht	Tehran		Iran, Islamic Republic of	0

Sponsors and Collaborators

Baqiyatallah Medical Sciences University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammad Sadegh Bagheri Baghdasht, Principal Investigator, Baqiyatallah Medical Sciences University

ClinicalTrials.gov Identifier:

NCT04463420

Other Study ID Numbers:

IR.BMSU.REC.1399.176

First Posted:

Jul 9, 2020

Last Update Posted:

Nov 4, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Nov 4, 2020