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IRCT20200325046859N2 IRCT 2020-04-26 Mashhad University of Medical Sciences effects of the 2-drug diet (hydroxychloroquine + umifenovir(Arbidol)) compared with Hydroxy chlorquine on the of mortality rate in patients with moderate symptoms of COVID-19 infections evaluation of the effects of the 2-drug diet (hydroxychloroquine + umifenovir(Arbidol)) compared with Hydroxy chlorquine on the of mortality rate in patients with moderate symptoms of COVID-19 infections: A randomized interventional study in Imam Reza Hospital, Mashhad. 2020-04-22 anticipated 100 Complete https://irct.ir/trial/47200 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be carried out using table of random numbers available at 'www.randomization.com' website where the produced numbers are placed in sealed envelopes assigning each patient to one of the two groups, Blinding description: The data analyst is unaware of the groups each patient belongs to. 2-3 COVID-19 disease. Intervention 1: Intervention group: In this group, patients with moderate symptoms of COVID-19 take the two-drug diet of 200 mg Hydroxy chlorquine (Made by Amin Pharmaceutical Company) with 2 tablets every 12 hours in the first day and 1 every 12 hours up to 7 days in addition to 100 mg Arbidol (Made in Russia (received from the Ministry)) every 8 hours 2 tablets for at least 7 days. Intervention 2: Control group: patients in this group routinely receive 200 mg Hydroxy chlorquine (Made by Amin Pharmaceutical Company) with 2 tablets every 12 hours in the first day and 1 every 12 hours up to 7 days. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Rozita Khodashahi
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 385022406 khodashahir@mums.ac.ir Mashhad University of Medical Sciences scientific Rozita Khodashahi
Imam Reza Hospital, next to Imam Reza square, Ibne Sina Street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2406 khodashahir@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Informed consent for inclusion in the study Age range within 18 to 65 Intial symptoms during the first 12 days Diagnosis with COVID-19 is definitive Moderate symptoms of COVID-19 and need for hospitalization, SPO2<93%, pulmonary infiltration in chest radiography or CT scan and clinical judgment of a specialist 18 years 65 years Both Pregnancy Having morbidities such as heart diseases which do not allow the use of treatment drugs History of retinopathy which does not allow the use of Hydroxy chlorquine. Patient with severe condition who will not last more than 48 hours Infection with HIV B34.2 Coronavirus infection, unspecified site Treatment - Drugs Treatment - Drugs Intervention group: In this group, patients with moderate symptoms of COVID-19 take the two-drug diet of 200 mg Hydroxy chlorquine (Made by Amin Pharmaceutical Company) with 2 tablets every 12 hours in the first day and 1 every 12 hours up to 7 days in addition to 100 mg Arbidol (Made in Russia (received from the Ministry)) every 8 hours 2 tablets for at least 7 days. Control group: patients in this group routinely receive 200 mg Hydroxy chlorquine (Made by Amin Pharmaceutical Company) with 2 tablets every 12 hours in the first day and 1 every 12 hours up to 7 days Fever. Timepoint: Before and after treatment. Method of measurement: Thermometer. Respiration rate. Timepoint: Before and after treatment. Method of measurement: Counting the number of breaths patients take per minute. Findings of chest CT scan. Timepoint: Before and after treatment. Method of measurement: CT scan machine. Pulse. Timepoint: Before, during and after treatment. Method of measurement: Patient monitoring device. SpO2. Timepoint: Before and after treatment. Method of measurement: Patient monitoring device. WBC. Timepoint: Before and after treatment. Method of measurement: Biochemical test. Number of lymphocytes. Timepoint: Before and after treatment. Method of measurement: Biochemical test. Lactate dehydrogenase. Timepoint: Before and after treatment. Method of measurement: Biochemical test. C reactive protein (CRP). Timepoint: Before and after treatment. Method of measurement: Biochemical test. Mashhad University of Medical Sciences Approved 2020-06-06 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)