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

ABSTRACT

ConditionCOVID-19.
COVID-19, virus identified;U07.1

InterventionIntervention 1 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. Intervention 2 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.

Primary outcome:Dyspnea. Timepoint The beginning of the study and the fifth day. Method of measurement 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.

CriteriaInclusion criteria informed 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)