COVID-19. Covid-19
Conditions
Interventions
Intervention 1: Intervention group: Capsule Umnifenovir 100 mg, 2 capsuls every 6 hours, for 7 days. (In addition to routine treatment according to the latest national guideline for the treatment of n
Sponsors
Center for Progress and Development of Iran
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactParisa Kianpour
Tehran University of Medical Sciences
Outcome results
None listed