search
Back to results

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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
PHR160 Spray
Placebo
Standard treatment
Sponsored by
Baqiyatallah Medical Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Mohammad Sadegh Bagheri BaghdashtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test Group

Control Group

Arm Description

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: 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 4, 2020
Last Updated
November 3, 2020
Sponsor
Baqiyatallah Medical Sciences University
search

1. Study Identification

Unique Protocol Identification Number
NCT04463420
Brief Title
Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baqiyatallah Medical Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
PHR160 Spray
Intervention Description
One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
participants will receive a placebo spray every hour. This process will continue for 10 days.
Intervention Type
Drug
Intervention Name(s)
Standard treatment
Intervention Description
: 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
Primary Outcome Measure Information:
Title
Dyspnea
Description
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.
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
long of hospitalization
Description
The length of time the patient is hospitalized after the diagnosis of COVID-19
Time Frame
up to 28 days
Title
Radiological Treatment Response
Description
CT scans help determine how much the lungs are affected by COVID-19.
Time Frame
up to 14 days
Title
Mortality
Description
In-hospital mortality
Time Frame
Up to 28 days
Title
Allergic drug
Description
There will be known allergic reactions to the drugs.
Time Frame
up to 14 days
Title
Laboratory Treatment Response
Description
Normal blood cell count and CRP count (normal laboratory range)
Time Frame
up to 14 days
Title
O2 saturation without supplemental oxygen
Description
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.
Time Frame
up to 14 days
Title
drug reactions Adverse
Description
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.
Time Frame
Up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Sadegh Bagheri Baghdasht
Phone
0098 9356318204
Email
sadegh.bagheri@gmail.com
Facility Information:
Facility Name
Mohammad Sadegh Bagheri Baghdasht
City
Tehran
ZIP/Postal Code
0
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Sadegh Bagheri Baghdasht
Phone
+989356318204
Email
sadegh.bagheri@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs