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IRCT20191211045691N2 IRCT 2020-11-02 Yazd University of Medical Sciences Evaluation of the efficacy and safety of Doxycycline in combination with standard treatment in Covid-19 patients Evaluation of the efficacy and safety of Doxycycline in combination with standard treatment in Covid-19 patients: a clinical trial 2020-09-14 anticipated 60 Complete https://irct.ir/trial/51951 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization (quadruple blocks) All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB We need 15 blocks to select 60 people. We randomly select these blocks from the numbers 1 to 6.Using R software, we choose a random number between the numbers 1 to 6. For example, number 6 is chosen as the first block and number 2 as the forth block. The people who enter the study are given B-A-A-BA- A-B-B, respectively. Finally, group A receives control intervention and group B receives treatment intervention, Blinding description: The researcher is unaware that the medicine given to the patient is the main medicine or placebo. The participant (patient) is also unaware that the medicine being given to them is the main medicine or placebo. 3 Evaluation of the efficacy and safety of doxycycline in combination with standard treatment in Covid-19 patients.. Intervention 1: Intervention group: includes 30 patients who receive doxycycline every 12 hours for 7 days along with standard treatment. Intervention 2: Control group: Includes 30 patients receive placebo every 12 hours for 7 days along with standard 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 No - There is not a plan to make this available
public Zohreh Akhoundi Meybodi
Infectious Diseases Research Center Shahid Sadoughi General Hospital Shahid Sadoughi University of Medical Sciences
Yazd Iran (Islamic Republic of) ۸۹۱۵۸۸۷۸۵۷ +98 35 3822 4000 drzakhondie@yahoo.com Yazd University of Medical Sciences scientific Mohammad Bagher Owlia
Department of Internal Medicine, School of Medicine Shahid Sadoughi General Hospital Shahid Sadoughi University of Medical Sciences
Yazd Iran (Islamic Republic of) ۸۹۱۵۸۸۷۸۵۷ +98 35 3822 4000 mbowlia2@ yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Minimum age 18 and maximum age 80 years Signing up the informed consent form Do not take ِdoxycycline during the past 5 days Patients suspected of covid-19 based on clinical signs and manifestations of CT scan Candidate for outpatient treatment 18 years 80 years Both Patients hospitalized Patients with hemodynamic instability Patients with a history of allergic reaction or allergy to doxycycline Second and third trimesters of pregnancy U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: includes 30 patients who receive doxycycline every 12 hours for 7 days along with standard treatment. Control group: Includes 30 patients receive placebo every 12 hours for 7 days along with standard treatment. Improve clinical symptoms including fever, shortness of breath, cough. Timepoint: Before starting the intervention and Days 1, 3, 7 and 14. Method of measurement: Questionnaire. Blood o2 saturation. Timepoint: Before starting the intervention and Days 3 and 7. Method of measurement: Pulse oximetry device. Mortality. Timepoint: Day 14. Method of measurement: Questionnaire. Hospitalization. Timepoint: Days 7 and 14. Method of measurement: Questionnaire. Yazd University of Medical Sciences Approved 2020-09-13 Ethics Committee in Biomedical Research, School of Medicine, Shahid Sadoughi University of Medical S دانشکده پزشکی ، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شهید صدوقی یزد ، بلوار شهدای گمنام ، بلوار استاد حسابی ، یزد ، ایران ، yazd Yazd Iran (Islamic Republic of)