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

NCT04463420 | Unknown DMC

• 1 other identifier: IR.BMSU.REC.1399.176
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• long of hospitalization

  up to 28 days

• Radiological Treatment Response

  up to 14 days

• Mortality

  Up to 28 days

• Allergic drug

  up to 14 days

• Laboratory Treatment Response

  up to 14 days

Study Arms (2)

Test Group

EXPERIMENTAL

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.

Drug: PHR160 Spray; Drug: Standard treatment

Control Group

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Standard treatment

Interventions

PHR160 Spray DRUG

One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.

Test Group

Placebo DRUG

participants will receive a placebo spray every hour. This process will continue for 10 days.

Control Group

Standard treatment DRUG

: 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

Control Group; Test Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baqiyatallah Medical Sciences University: lead

Study Sites (1)

Mohammad Sadegh Bagheri Baghdasht

Tehran, 0, Iran

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Mohammad Sadegh Bagheri Baghdasht

CONTACT

0098 9356318204; sadegh.bagheri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2020
• First Posted: July 9, 2020
• Study Start: August 15, 2020
• Primary Completion: November 15, 2020
• Study Completion: December 15, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

IR (1)