Study aim:
Evaluation of the efficacy and safety of Umifenovir in control the respiratory symptoms of patients with COVID-19
Design:
This study is a single-center, prospective, randomized, open-labeled, controlled,parallel phase 3 clinical trial.
Settings and conduct:
Patients admitted to Baqiyatallah hospital, who are met the inclusion criteria, is entered to the study are randomly assigned into two groups of intervention and control.
Participants/Inclusion and exclusion criteria:
Inclusion Criteria:
1.Age ≥18 years; 2. Announcing written and informed written consent to participate in the study. 3. Laboratory (RT-PCR) confirmation. 4.lung CT-Scan confirmation, which is typical for COVID-19 pulmonary involvement. 5. O2 saturation<93% on room air, at rest.
Exclusion Criteria:
1. Hypersensitivty reaction to Umifenovir; 2. Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2. 3. patient with at least one of these underlying disease: congenital heart disease, congestive heart failure, coronary artery disease, severe heart rhythm disorders, serious neurological diseases such as stroke, epilepsy, mental retardation, spinal cord injury. 4. Patients with immunodeficiency, including malignancy, HIV, organ transplantation, receiving immunosuppressive drugs in the last 3 months. 5. pregnancy or lactation; 6. involvement to another clinical study.7. Patient with critical condition (shock, respiratory failure, multi-organ failure)
Intervention groups:
intervention group: Capsule Umifenovir 100mg, 2 Capsules every 6 hours, for 7 days (In addition to routine COVID-19 treatment based on the latest national guideline for the treatment of new corona virus)
Control group:routine COVID-19 treatment based on the latest national guideline for the treatment of new corona virus.
Main outcome variables:
clinical symptoms changes (dry cough, respiratory distress, fever)
IRCTID: IRCT20080901001165N46