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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04463420
• Other study ID #: IR.BMSU.REC.1399.176
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: November 2020
• Source: Baqiyatallah Medical Sciences University
• Contact: Mohammad Sadegh Bagheri Baghdasht
• Phone: 0098 9356318204
• Email: sadegh.bagheri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

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.
• 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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mohammad Sadegh Bagheri Baghdasht	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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