COVID-19 trials registries data warehouse

http://en.irct.ir/trial/55727

Dr. Majid Saeidi

msaidi@mazums.ac.ir

2021-05-07

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Children and adults with moderate to severe COVID-19 (moderate: Evidence of pulmonary involvement or symptoms on imaging. severe: Respiratory rate more than 30 times per minute + percentage of blood oxygen saturation less than 93% + infiltration more than 50% in the lungs) Having one of the following symptoms: Dry cough, severe weakness and fatigue, dyspnea, chest pain, fever greater than 38° C Less than 3 days have passed since the first sign started Definitive diagnosis of Covid-19 based on RT-PCR test "or" Involvement of a maximum of 3 or 4 pulmonary lobes with an area less than one third of the volume of each lobe "or" Infection of one or two lobes with a larger area in the patient's CT scan view

Patient who has previously had COVID-19 or has been hospitalized for COVID-19 Participate in any other clinical trial for the treatment of COVID-19 Bradycardia, abnormal primary ECG Active cancer, immunodeficiency or treatment with immunosuppressive drugs Underlying liver and kidney disease

2

Mazandaran University of Medical Sciences

4

100

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

60

Secondary pulmonary bacterial infection

Phase 3

[{"arm_notes": "", "treatment_id": 981, "treatment_name": "Phage therapy", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]