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

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

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 Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: PHR160 Spray; Drug: Standard treatment; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Mohammad Sadegh Bagheri Baghdasht
    • Contact: Mohammad Sadegh Bagheri Baghdasht; Phone Number: +989356318204; Email: sadegh.bagheri@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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; Drug: Placebo; participants will receive a placebo spray every hour. This process will continue for 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea	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.	up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
long of hospitalization	The length of time the patient is hospitalized after the diagnosis of COVID-19	up to 28 days
Radiological Treatment Response	CT scans help determine how much the lungs are affected by COVID-19.	up to 14 days
Mortality	In-hospital mortality	Up to 28 days
Allergic drug	There will be known allergic reactions to the drugs.	up to 14 days
Laboratory Treatment Response	Normal blood cell count and CRP count (normal laboratory range)	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.	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.	Up to 14 days

Collaborators and Investigators

• Sponsor: Baqiyatallah Medical Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Anticipated): November 15, 2020
• Study Completion (Anticipated): December 15, 2020

Study Registration Dates

• First Submitted: July 4, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IR.BMSU.REC.1399.176

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No