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IRCT20200913048708N1 IRCT 2020-10-01 Mazandaran University of Medical Sciences Efficacy and safety of Chlorpromazine in the treatment of COVID-19 patients CIC Evaluation of efficacy and safety of adding Chlorpromazine to Atazanavir/Ritonavir regimen in the treatment of COVID-19 patients, a randomized double-blind clinical trial 2020-10-31 anticipated 60 Complete https://irct.ir/trial/50959 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using block randomization. 5-digits’ codes will be obtained by Excel program and patients will be randomly assigned to intervention and control groups. Each randomization unit will be a block of six blocks including 4 patients in each block (AABB, ABBA, ABAB, BBAA, BAAB and BABA). The sequence of blocks will be determined with a dice that numbers of 1 to 6 written on it. Allocation concealment will be carried out through inserting the study drugs in matt containers with identical appearance and 5 digits’ codes written on it, Blinding description: A separate 5-digit code obtained from the computer will be assigned to each patient.The intervention, including the drug or placebo, will be placed in identical containers, and the senior researcher will insert the code on the containers. The researcher and patient will not be aware of the type of intervention received. 2 COVID-19. Intervention 1: Intervention group: Patients with covid 19 infection will receive standard treatment of Atazanavir/Ritonavirdrug 300/100 mg (Razavi Pharmaceutical Institute) once daily in addition to chlorpromazine 25 mg (Tehran Shimi Company) three times a day. Maximum time of intervention will be 14 days. Intervention 2: Control group: Patients with covid 19 infection will receive standard treatment of Atazanavir/Ritonavirdrug 300/100 mg (Razavi Pharmaceutical Institute) once daily in addition to Placebo three times a day. Maximum time of intervention will be 14 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patients data
public Ebrahim Salehifar
15 Khordad street -Mahdieh 7 ave
Sari Iran (Islamic Republic of) 4818893716 +98 11 3340 6746 Esalehifar52@gmail.com Mazandaran University of Medical Sciences scientific Roya Ghasemian
No 8 street
Sari Iran (Islamic Republic of) 48168-13393 +98 11 3337 9692 roya31gh@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) all admitted patients with covid -19 infection based on clinical findings ,PCR or lung CT abnormality consistent with covid-19 spo2 bellow 93 mmHg age above 18 years old 18 years no limit Both patient rejection history of antipsycotic use history of seizure, dementia and parkinson disease Hx of liver disease Hx of feochromocytoma allergy to phenothiazines drug any drug interaction between patients medicines and chlorpromazine pregnancy and lactation Hx of covid treatments bradycardia < 60 /min multi-organ failure U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Patients with covid 19 infection will receive standard treatment of Atazanavir/Ritonavirdrug 300/100 mg (Razavi Pharmaceutical Institute) once daily in addition to chlorpromazine 25 mg (Tehran Shimi Company) three times a day. Maximum time of intervention will be 14 days. Control group: Patients with covid 19 infection will receive standard treatment of Atazanavir/Ritonavirdrug 300/100 mg (Razavi Pharmaceutical Institute) once daily in addition to Placebo three times a day. Maximum time of intervention will be 14 days. Patients level of Spo2. Timepoint: daily. Method of measurement: puls oximetr. Need to ICU admission. Timepoint: During the study. Method of measurement: Follow up of patient and documentation of the ICU admission. Days stayed in the Intensive Care Unit. Timepoint: During the study. Method of measurement: Documenting the days stayed in the Intensive Care Unit. Days stayed in the hospital. Timepoint: At the end of the study. Method of measurement: Documentation of the hospital stay according to patients chart. Mortality rate. Timepoint: At the end of the study. Method of measurement: Follow up of patients and documentation of the mortality. Mazandaran University of Medical Sciences Approved 2020-08-12 ethics committee of Mazandaran University of Medical Sciences Number 8, Shahid moini ave , Amir mazandarani Street , Sari, Iran Sari Mazandaran Iran (Islamic Republic of)