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
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

Unknown status
COVID-19

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

Eligibility Criteria

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Iran, Islamic Republic of
Locations

Mohammad Sadegh Bagheri Baghdasht
Tehran, Iran, Islamic Republic of

Investigator: Mohammad Sadegh Bagheri Baghdasht
Contact: +989356318204
sadegh.bagheri@gmail.com

Contacts

Mohammad Sadegh Bagheri Baghdasht
0098 9356318204
sadegh.bagheri@gmail.com

Baqiyatallah Medical Sciences University
NCT Number
MeSH Terms
COVID-19