COVID-19 trials registries data warehouse

http://en.irct.ir/trial/47087

Morteza Pirali

info@cpdi.ir

2020-04-15

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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%

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.

2

Center for Progress and Development of Iran

18

None

Iran

Severe disease at enrollment

6: Severe disease at enrollment

200

respiratory symptoms (dry cough) respiratory symptoms (respiratory distress) respiratory symptoms (fever)

Phase 3

[{"arm_notes": "", "treatment_id": 1336, "treatment_name": "Umifenovir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]