MedPath

Investigating the efficacy and safety of Azithromycin inhaled spray in controlling the symptoms of patients with COVID-19

Phase 3
Recruiting
Conditions
COVID-19.
Covid-19
U07.1
Registration Number
IRCT20080901001165N50
Lead Sponsor
Sina Darou Laboratories Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
80
Inclusion Criteria

Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study.
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.

Exclusion Criteria

History of allergy to this nasal spray ingredients;
Hypersensitivity reaction while taking this inhaled spray;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the intensive care unit;
Pregnancy;
Lactation.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical symptoms (dry cough). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire.;Clinical symptoms (respiratory distress). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Pulse-oxymetery device.;Clinical symptoms (fever). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Thermometer.
Secondary Outcome Measures
NameTimeMethod
ab. tests changes. Timepoint: Daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist. Method of measurement: Blood sample, laboratory analysis.;Side effects. Timepoint: Daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist. Method of measurement: Physical examination.
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