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IRCT20111224008507N6 IRCT 2021-05-07 Mazandaran University of Medical Sciences Phage therapy for prevention of secondary bacterial pneumonia in COVID-19 Clinical trial of ealuation of phage therapy with nebulizer in prevention of secondary bacterial pneumonia in admitted patients with moderate to severe COVID-19 2021-05-10 anticipated 60 Complete https://irct.ir/trial/55727 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 60 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 30 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 60, Blinding description: To increase the validity of the data obtained from the study and prevent bias, the study will be conducted in a double-blind manner. In this study, patients and researchers (nurses, physicians) do not know which group consumes phage cocktail and which group consumes non-phage suspension and are considered blind. Phage cocktail and placebo are prepared in completely uniform packages for nebulization And the group A and B labels are marked on the products by the partner who produces cocktails and placebo. The laboratory colleague is not involved in statistical analysis and review of results. 3 COVID-19. Intervention 1: Intervention group: For 7 days, once daily, 10 ml of bacteriophage cocktail solution with a titer of one trillion pfu (Plaque Forming Units) per ml is nebulized once a day. Intervention 2: Control group: For 7 days, once daily, receive 10 ml of the base suspension solution without bacteriophage cocktail as a nebulizer. Yes - There is a plan to make this available What will be shared: Part of the data is accessible When: starting in junuary 2022 To whom: Physicians Conditions: Systematic review articles Where to obtain: Contact Dr.Mohammad Sadegh Rezai. Email: drmsrezaii@yahoo.com How to obtain: Informations will send within few days after the call. Comments:
public Dr Mohammad Sadegh Rezai
Boali Hospital,Pasdaran Blv.
Sari Iran (Islamic Republic of) 47128-55689 +98 15 1325 7230 rezai@mazums.ac.ir Mazandaran University of Medical Sciences scientific Mohammadsadegh Rezai
Bouali Hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 drmsrezaii@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 4 years no limit Both 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 U07.1 COVID-19, virus identified Prevention Placebo Intervention group: For 7 days, once daily, 10 ml of bacteriophage cocktail solution with a titer of one trillion pfu (Plaque Forming Units) per ml is nebulized once a day. Control group: For 7 days, once daily, receive 10 ml of the base suspension solution without bacteriophage cocktail as a nebulizer. Secondary pulmonary bacterial infection. Timepoint: Before the intervention and days 1 to 7, and 14 and 21 days after treatment. Method of measurement: Sputum culture, CT scan, clinical signs (fever, coughو ...). Blood oxygen saturation. Timepoint: 10 and 14 days after treatment. Method of measurement: Palsoxymeter. Survival rate. Timepoint: After hospitalization. Method of measurement: Recoed of recovery or death. Number of hospitalization days. Timepoint: Initiation of hospitalization until after discharge or death. Method of measurement: Number of days. Number of days of intubation. Timepoint: Start intubation until the tube separates or death. Method of measurement: Number of days. Number of days in the ICU. Timepoint: Start entering the ICU until discharge from the ICU. Method of measurement: Number of days. Body temprature. Timepoint: Daily until 14 days. Method of measurement: Thermometer. Cough. Timepoint: Daily until 14 days. Method of measurement: Observation and asking the patient. Fatigue. Timepoint: Daily until 14 days. Method of measurement: Observation and asking the patient. Mazandaran University of Medical Sciences Approved 2021-01-04 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for Research, Moallem square, Sari Sari Mazandaran Iran (Islamic Republic of)