drugset / Trial / NCT04463420

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

NCT04463420

RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2020-08-15
Primary completion
2020-11-15
Completion
2020-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject PHR160 Unknown 300 mg Oral
Background Azithromycin Small molecule 250 mg
Background Famotidine Other / unclassified 40 mg
Background Hydroxychloroquine Small molecule 400 mg
Background Naproxen Small molecule 250 mg
Background Prednisolone Other / unclassified 25 mg

Indications