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IRCT20200408046992N1 IRCT 2020-04-14 Birjand University of Medical Sciences Effect of Trifluoperazine in treatment of COVID-19 Evaluation of the Effect of Trifluoperazin in Treatment of Patients with Confirmed 2019 Novel Coronavirus(COVID- 19): An Open-Label Randomized Clinical Trial 2020-04-16 anticipated 70 Complete https://irct.ir/trial/47006 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization. 3 COVID-19 disease. Intervention 1: Intervention group:35 participants in the investigational treatment group will receive trifluoprazine at a dose of 5 mg twice daily for 14 days on admission in addition to standard treatment consisting of hydroxychloroquine. If necessary, according to the approved treatment protocol, kaletra and ribavirin would be added to the treatment. Intervention 2: Control group:35 participants in control group, would receive standard treatment protocol consisting hydroxychloroquine and , if necessary, according to the approved treatment protocol, kaletra and ribavirin would be added to the treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Masood Ziaee
Ghafari Street,
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3238 1200 dr.m.ziaee@gmail.com Birjand University of Medical Sciences scientific Kazem Dastjerdi
Building No 56, Edaalat 4, Birjand
Birjand Iran (Islamic Republic of) 9718673131 +98 56 3243 2639 dastjerdi1974@hotmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Patients with laboratory-confirmed COVID 19 infection with Real Time PCR and patients with evidence of lung involvement in CT Scan Willing to provide informed consent Age older than 12 years. Patients admitted to specialized COVID-19 ward Patients without Known severe allergy to trifluoperazine perazin and other phenothiazines such as cholorphenothiazines Patients older than age 65 years are included if they do not suffer from Dementia-Related Psychosis 12 years no limit Both Patient With a Liver Disorder Patients with bacterial or viral infection Pregnant women Patients with benign prostatic hyperplasia (BPH) Patients with intestinal obstruction Patients with blood disorders or bone marrow failure Coma patients and patients with central nervous system weakness U07.1 Pneumonia due to SARS-associated coronavirus Treatment - Drugs Treatment - Drugs Intervention group:35 participants in the investigational treatment group will receive trifluoprazine at a dose of 5 mg twice daily for 14 days on admission in addition to standard treatment consisting of hydroxychloroquine. If necessary, according to the approved treatment protocol, kaletra and ribavirin would be added to the treatment Control group:35 participants in control group, would receive standard treatment protocol consisting hydroxychloroquine and , if necessary, according to the approved treatment protocol, kaletra and ribavirin would be added to the treatment Determining the efficacy of trifluoprazine in improving the Clinical manifestations of patients with confirmed COVID-19 infection by recording the patient's clinical parameters including 7 clinical parameters of respiration number, Blood Oxigen Saturation, oxygen support, temperature, heart rate, systolic blood pressure and Awareness level, assessment of lung involvement with Chest CT-Scan, measurement of c-reactive protein on treatment days, measurement of CBC indicators and biochemical factors such as urea and creatinine. Timepoint: Check of the patient's clinical condition and blood sampling of patients on days 1-14 in the hospital and also on the 28th day after the onset of the disease. Method of measurement: Measuring CBC indicators and biochemical factors using an autoanalyzer and examining heart function using EKG,Measurement of other factors using a thermometer and blood pressure monitor and patient bedside examinations. Birjand University of Medical Sciences Approved 2020-04-08 Ethics committee of Birjand University of Medical Sciences Birjand University of Medical Sciences , Ghafari Street, Birjand, birjand South Khorasan Iran (Islamic Republic of)