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IRCT20200509047373N2 IRCT 2021-04-13 Health Medicine Chemistry Company Effect of new trial drug on clinical and paraclinical symptoms in COVID-19 Effect of new trial drug on improving of clinical and paraclinical symptoms in patients ICU with COVID-19 2021-04-14 anticipated 120 Complete https://irct.ir/trial/50551 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to trial groups (intervention and placebo groups) randomly trough site www.randomization.com block sizes of 4 with an allocation ratio of 1:1. Patients will receive a new trial drug sublingual 433 ± 5 mg or placebo . 6 sublingual drops will be taken every 3hour for 14days . Random sequencing allocation will be produced by the person who has not to participate in the research. drops will be numbered from 1 to 120 according to the sequence generated. Both groups will receive routine treatments, Blinding description: This study is a randomized controlled two-blind clinical trial. This means that patient, researcher, safety and data monitoring committee, clinical caregiver and statistical analyst will be blind to the received medication. Each person will be given a new trial drug or placebo in the identical shape and weight. 3 COVID-19. Intervention 1: In the intervention group, participants will receive new trial drug 6 drops every 3hours for 14 days. The control group will receive a placebo (no therapeutic value), resembled the herbal medicine with the same prescription. Both groups will receive routine treatments. Intervention 2: Control group: The control group will receive a placebo, resembled the new trial drug with the same prescription. Both groups will receive routine treatments. Yes - There is a plan to make this available What will be shared: All participants' data can be shared after it becomes unrecognizable When: End of october To whom: healthcare professional- َacademic members of universities Conditions: An official request from the organization Where to obtain: Shiraz University of Medical Sciences How to obtain: In case of requesting data for the study, the applicant must first introduce himself or herself and the relevant organization to determine the purpose of the data request and state for what purpose this data is used.After submitting the request, if the researchers of this study prove that the data of this study can advance the therapeutic goals, the information will be sent as long as the data remains confidential.This process takes two weeks. Comments:
public Ahmad Hosseinpour
No. 256, alley 7, Solh boulevard, Maharat square
Shiraz Iran (Islamic Republic of) 7177654547 +98 71 3739 7910 ahosseinpour3@gmail.com Health Medicine Chemistry Company scientific Ahmad Hosseinpour
No. 256, alley 7, Solh boulevard, Maharat square
Shiraz Iran (Islamic Republic of) 7177654547 +98 71 3739 7910 ahosseinpour3@gmail.com Health Medicine Chemistry Company Iran (Islamic Republic of) Having definite COVID-19 disease and get hospitalized Both sexes Age over 15 years Obtaining informed consent to participate in the trial Non-participation in another clinical trial simultaneously Patients admitted to ICU 15 years no limit Both Diagnosis of the disease just based on physician diagnosis Pregnancy (according to the patient's statement and examination by a physician) Breastfeeding (according to the patient's statement) U07.1 COVID-19, virus identified Treatment - Drugs Placebo In the intervention group, participants will receive new trial drug 6 drops every 3hours for 14 days. The control group will receive a placebo (no therapeutic value), resembled the herbal medicine with the same prescription. Both groups will receive routine treatments. Control group: The control group will receive a placebo, resembled the new trial drug with the same prescription. Both groups will receive routine treatments. Respiratory Rate. Timepoint: Daily. Method of measurement: Observation. Oxygen saturation (SpO2). Timepoint: Daily. Method of measurement: Pulse Oximeter. Serum White Blood Cell count. Timepoint: Before intervention and 14 days after intervention. Method of measurement: Laboratory cell counter. Serum CRP level. Timepoint: Before intervention and 14 days after intervention. Method of measurement: Biochemical method. ESR (Erythrocyte Sedimentation Rate). Timepoint: Before intervention and 14 days after intervention. Method of measurement: Checking the sedimentation rate of erythrocytes in a special tube within one hour. Number of hospitalization days. Timepoint: After intervention. Method of measurement: Questionnaire. Mortality. Timepoint: Daily. Method of measurement: Questionnaire. The end time of dry Cough. Timepoint: Daily. Method of measurement: ِDaily symptom recording questionnaire. The time of recovery from difficulty in breathing or shortness of breath. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire. The time of recovery of temperature equal to or grater than 37.8 C. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire. Health Medicine Chemistry Company Approved 2021-03-15 Ethics Committee of Shiraz University of Medical Sciences Vice chancellor for research affairs, seventh floor, Shiraz University of Medical Science, beside Helal Ahmar, Zand Ave, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)