Efficacy evaluation of inhalation therapy (nasal spray) of Interferon Beta-1a in hospitalized Covid-19 patients

Phase 3

Recruiting

Conditions: COVID-19.
COVID-19, virus identified
U07.1

Registration Number: IRCT20200511047396N1

Lead Sponsor: CinnaGen company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients who have Covid-19 based on the CT-scan or RT-PCR findings
Hospitalized patients
Willingness to participate in the study for trial period and signing the informed consent form
Age between 20-65

Exclusion Criteria

Pregnancy
Breastfeeding
Use of ARB/ACEi
History of hypotension
have no consent to participate in the study
Allergic sensitivity to the interferon products
Not availability of phone number or it is possible to be transferred to other hospitals
Having the CKD or patients who need dialysis at the begining of the study
Having any disease or condition that based on the physician judgment cannot participate in the study
Participation in any other trials of Covid-19

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome was the evaluation of 50% reduction of viral load or negative results of virus before day 7. Timepoint: before drug administration, day 3, day 5, and day 7 (before negative result until day 7). Method of measurement: RT-PCR test.

Secondary Outcome Measures

Name	Time	Method
umber of days with fever (more than 37.2) up to 7 days. Timepoint: Daily up to day 7. Method of measurement: Thermometer.;Number of days with dyspnea until day 7. Timepoint: Daily up to day 7. Method of measurement: Clinical examination by investigator or history review of the patients.;Number of days that patients need supplemental oxygenation up to day 7. Timepoint: Daily up to day 7. Method of measurement: Examination by investigator.;Change of laboratory results of patients before treatment and last day of study (day 7). Timepoint: Before drug administration and last day of study. Method of measurement: Laboratory results.;Adverse events. Timepoint: Daily up to day 7. Method of measurement: Investigator report.;Number of days that patients have dry cough. Timepoint: Daily until day 7. Method of measurement: Examination by investigator.