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

Baqiyatallah Medical Sciences University

Status: Unknown

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: Standard treatment; Drug: PHR160 Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT04463420

IR.BMSU.REC.1399.176

Details and patient eligibility

About

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

Enrollment: 224 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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224 participants in 2 patient groups, including a placebo group

Test Group

Experimental group

Description:

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.

Treatment:

Drug: Standard treatment

Drug: PHR160 Spray

Control Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Standard treatment

Drug: Placebo