]>
IRCT20200404046932N1 IRCT 2021-10-14 Hakiman e Shargh Research Co. Therapeutic effect of FLUVAR® for COVID-19 Efficacy evaluation of FLUVAR® in the onset of the disease with symptoms of respiratory infection synonymous with the symptoms of COVID-19 in patients referred to emergency departments and clinics 2020-05-21 anticipated 100 Complete https://irct.ir/trial/58879 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The study has two stages. The first step is done with two parallel groups of medication and placebo. After interim analysis, if drug efficacy is confirmed, the study is continued without placebo group and the results of medication group are compared with control group without receiving FLOVAR®. All groups receive standard care and treatment, Randomization description: Similar medicine containers are used for medicine and placebo. After filling the vials with medication and placebo, random codes are assigned to them using a random number table, Blinding description: The researcher is unaware of which medication or placebo is being delivered / The medication and placebo formulator is unaware of the recipients / The prescriber of the medication and placebo is unaware of the grouping and content of the containers / The volunteers are unaware of the contents of their medication containers /The collector of outcomes and the analyst are unaware of the groups. 2 COVID-19. Intervention 1: Intervention group 1- First intervention stage: Care and treatment based on standard protocol + Receiving single dose (5 ml) of FLUVAR® using a Pari Master nebulizer connected to the patient's oxygen uptake pathway. Intervention 2: Intervention group 2- First intervention stage: Care and treatment based on standard protocol + Receiving single dose (5 ml) of normal saline using a Pari Master nebulizer connected to the patient's oxygen uptake pathway. Intervention 3: Intervention group 3- Second intervention stage: Care and treatment based on standard protocol + Receiving FLUVAR® using a Pari Master nebulizer connected to the patient's oxygen uptake pathway, 5ml every dose, two times a day, up to 2 weeks. Intervention 4: Control group- Second intervention stage: Care and treatment based on standard protocol. No - There is not a plan to make this available Justification or reason for not sharing IPD is Protection of patients' confidential medical information
public Sayyed Ali Alavi
Technology Park, Isfahan Science & Technology Town, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8415683111 +98 31 3667 1780 Sayyedalialavi@gmail.com Hakiman e Shargh Research Co. scientific Sayyed Ali Alavi
Technology Town, Isfahan Science & Technology Town
Isfahan Iran (Islamic Republic of) 8415683111 +98 31 3667 1780 sayyedalialavi@gmail.com Hakiman e Shargh research Co. Iran (Islamic Republic of) Age 18 years and older Signing informed consent Possessing two distinct respiratory signs of COVID-19 O2Sat below 94% or positive signs on CT scan or positive PCR result for COVID-19 18 years no limit Both History of moderate or severe respiratory asthma Participating in another clinical trial for COVID-19 U07.1 COVID-19 disease Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1- First intervention stage: Care and treatment based on standard protocol + Receiving single dose (5 ml) of FLUVAR® using a Pari Master nebulizer connected to the patient's oxygen uptake pathway Intervention group 2- First intervention stage: Care and treatment based on standard protocol + Receiving single dose (5 ml) of normal saline using a Pari Master nebulizer connected to the patient's oxygen uptake pathway Intervention group 3- Second intervention stage: Care and treatment based on standard protocol + Receiving FLUVAR® using a Pari Master nebulizer connected to the patient's oxygen uptake pathway, 5ml every dose, two times a day, up to 2 weeks Control group- Second intervention stage: Care and treatment based on standard protocol O2sat difference one hour post intervention. Timepoint: One hour after the intervention. Method of measurement: Pulse oximeter instrument. Dyspnea scale. Timepoint: One hour after the intervention. Method of measurement: By Visual Analogue Scale questionnaire (VAS). Intervention side effects. Timepoint: From the beginning to one day after the end of the intervention. Method of measurement: Observation and interview questionnaire. Hakiman e Shargh Research Co. Approved 2020-05-12 Ethics Committee of Isfahan University of Medical Sciences Ethics Committee of Isfahan University of Medical Sciences, Hezarjarib Blvd, Isfahan Isfahan Isfehan Iran (Islamic Republic of)