NCT04463420

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Baqiyatallah Medical Sciences University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• COVID-19

Interventions

Type	Name	Description
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	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

Timeline

• Start date: 2020-08-15
• Primary completion: 2020-11-15
• Completion: 2020-12-15
• First posted: 2020-07-09
• Last updated: 2020-11-04

Locations

1 site across 1 country: Iran