MedTrace Logo

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

NCT04463420 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2020-11-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Baqiyatallah Medical Sciences University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04463420 on ClinicalTrials.gov