Investigating the efficacy and safety of Umifenovir in controlling the symptoms of patients with COVID-19

Phase 3

Recruiting

Conditions: COVID-19.
Covid-19
U07.1

Registration Number: IRCT20080901001165N46

Lead Sponsor: Center for Progress and Development of Iran

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

age >18 years
The patient have written consciously and freely consent to participate in the study.
Confirmed diagnosis of COVID-19, with Laboratory (RT-PCR) confirmation.
Confirmed diagnosis of COVID-19, with lung CT-Scan result, which is typical for COVID-19 pulmonary involvement.
O2 saturation at rest in ambient air =93%

Exclusion Criteria

Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2.
Participation in any other clinical trial of an experimental treatment for COVID-19
Pregnant or breastfeeding;
Hypersensitivity reaction history with Umifenovir.
patient with critical stage of disease (respiratory failure, sock, multi organ dysfunction)
patient with at least one of these disease as past medical history: congenital heart disease, Congestive heart failure, coronary artery disease, severe heart rhythm disorders, serious neurological disease including stroke, epilepsy, mental retardation, spinal cord injury.
Patients with immunodeficiency, including malignancies, HIV, organ transplants, receiving immunosuppressive drugs in the last previous 3 months.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory 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.;Respiratory 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.;Respiratory 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

Name	Time	Method
Radiologic finding changes in Lung CT-scan. Timepoint: before the intervention initiation (baseline), then at day 14. Method of measurement: Lung CT-scan.;Lab 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.;Mortality rate. Timepoint: day 14 of intervention initiation. Method of measurement: questionnaire.;Adverse Effects. Timepoint: daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist. Method of measurement: questionnaire, clinical examination.;Inflammatory biomarker level changes (including interleukin 1, interleukin 6, TNF alpha). Timepoint: before the intervention initiation (baseline), then at day 7. Method of measurement: Elisa kit for Human.