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Evaluation of the effectiveness of PHR-160 spray in hospitalized patients with Covid-19

Phase 1
Recruiting
Conditions
COVID-19
U07.1
covid-19.
Registration Number
IRCT20201223049816N1
Lead Sponsor
Bagheiat-allah University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
240
Inclusion Criteria

Both sexes
Ages 15-75
Oxygen saturation percentage between 88 and 93%.
Confirmation of 19 patients using RTPCR.
Confirmation of Covid-19 using CT scan
Signing a informed consent form

Exclusion Criteria

Attending another trial in the last three months
pregnancy/lactation
drug sensitivity to the ingredients in the intervention
very high severity of the disease in the emergency room (consciousness less than 15 / oxygen concentration less than 88%, etc)
history of chronic respiratory disease
Previous pulmonary embolism (last three months)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of oxygen saturation in two intervention groups after randomization. Timepoint: 1. After randomization at the beginning of the patient's arrival, and every day. Method of measurement: Using Pulse Oximeter.
Secondary Outcome Measures
NameTimeMethod
The time required to reduce at least one grade of disease severity according to the Covid-19 national guideline. Timepoint: Every day. Method of measurement: Data collection and data management will be done using electronic patient report forms and electronic data management system, and the steps of data cleaning and locking and data monitoring will be done on-line during the study.;Number and percentage of patients with adverse events and number and percentage of total adverse events. Timepoint: Evry day. Method of measurement: Data collection and data management will be done using electronic patient report forms and electronic data management system, and the steps of data cleaning and locking and data monitoring will be done on-line during the study.
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