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IRCT20200418047122N1 IRCT 2020-05-03 Esfahan University of Medical Sciences Evaluation of the therapeutic effect of a combination drug including Apocynin, Niacin, and Tannin on COVID-19 Evaluation of the protective effect of a combination drug including Apocynin, Niacin, and Tannin on prevention of cardiovascular and respiratory morbidities and mortality in COVID-19 infection: A Clinical Trial 2020-04-25 anticipated 80 Complete https://irct.ir/trial/47268 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Altogether, 80 patients confirmed for COVID-19 are recruited into two groups through permuted block randomization approach. The block size will be considered of size 4. Each group included 40 cases and 40 controls. 2-3 COVID-19-induced pneumonia. Intervention 1: Intervention group: This group includes inpatient cases with mild to moderate respiratory problems that are confirmed for corona infection. In phase II non-randomized clinical trial, at first, 5 patients confirmed with COVID-19 and non-serious presentations are included in a pilot study from which informed consents have been gotten. The current standard treatments are given to the patients in an open-labeled approach and combinative drug including: two capsules and two spoonfuls of syrup per day including Niacin-Tannin in capsule and Apocynin in syrup with Bid consumption of Tannin(125mg) + Niacin(5mg) and one spoonful apocynin (2.5mg) up to 14 days. The control group only receives current treatment. . Then the side-effects and efficacies will be evaluated. If no side-effects are observed and therapeutic outcomes are positive, the results will be reported to the RCT assessment committee. If the permission is given, the trial will continue with more patients up to 20% of all experimental cases. Then the evaluation will be repeated. If the results are approved again, the study will continue on all the cases according to the following statement. In this clinical trial we will finally recruit 80 patients infected by COVID19 in two groups of experimental and control. Except in the pilot phase that the control group is not included, in the following, the control group will be also added with just standard treatment until 14 days follow-up and clinical assessment. If a patient is discharged from the hospital, his/her follow-up of the treatment and clinical evaluation will continue at home via daily interview by phone. The necessary education will be presented for all the patients and their families before discharging. Intervention 2: Control group: This group includes the patients with mild to moderate respiratory problems that are confirmed for Corona infection. 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 It depends on the conditions in the study.
public Dr Hossein Khanahmad
Hezar Jarib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 9197 hossein_khanahmad@yahoo.com Esfahan University of Medical Sciences scientific Dr Hossein Khanahmad
Hezar-Jarib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 9197 hossein_khanahmad@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age more than 18 years Clinical and paraclinical signs and symptoms for COVID19-induced pneumonia inpatient setting Positive PCR for COVID19 Informed consent 18 years no limit Both Pregnancy A recent medical history of using ACEI and ARB drugs, fludrocortisone, spironolactone, eplerenone, TCA antidepressant, Simvastatin, MAO inhibitors, serotonin inhibitors such as sertraline and citalopram, Triptamins, Alcoholism Heart Failure (EF<25%) Hepatic failure (Child Pugh score ≥ C ,AST> 5 times of the upper limit normal) Severe renal dysfunction (GFR less than 30cc per min) Any drug side-effects including: Patients’ intolerance, Diarrhea, Gastrointestinal problems Active peptic ulcer Active Bleeding U07.01 COVID-19 Treatment - Drugs N/A Intervention group: This group includes inpatient cases with mild to moderate respiratory problems that are confirmed for corona infection. In phase II non-randomized clinical trial, at first, 5 patients confirmed with COVID-19 and non-serious presentations are included in a pilot study from which informed consents have been gotten. The current standard treatments are given to the patients in an open-labeled approach and combinative drug including: two capsules and two spoonfuls of syrup per day including Niacin-Tannin in capsule and Apocynin in syrup with Bid consumption of Tannin(125mg) + Niacin(5mg) and one spoonful apocynin (2.5mg) up to 14 days. The control group only receives current treatment. . Then the side-effects and efficacies will be evaluated. If no side-effects are observed and therapeutic outcomes are positive, the results will be reported to the RCT assessment committee. If the permission is given, the trial will continue with more patients up to 20% of all experimental cases. Then the evaluation will be repeated. If the results are approved again, the study will continue on all the cases according to the following statement. In this clinical trial we will finally recruit 80 patients infected by COVID19 in two groups of experimental and control. Except in the pilot phase that the control group is not included, in the following, the control group will be also added with just standard treatment until 14 days follow-up and clinical assessment. If a patient is discharged from the hospital, his/her follow-up of the treatment and clinical evaluation will continue at home via daily interview by phone. The necessary education will be presented for all the patients and their families before discharging. Control group: This group includes the patients with mild to moderate respiratory problems that are confirmed for Corona infection Fever. Timepoint: BID. Method of measurement: Thermometer. Hemodynamic signs. Timepoint: BID. Method of measurement: P/E. O2 sat. Timepoint: BID. Method of measurement: Puls-Oximetery. Clinical symptomes. Timepoint: TDS. Method of measurement: P/E and medical hx. Drug side-effects. Timepoint: Continuous. Method of measurement: PE and MH. Survival and clinical symptoms. Timepoint: Continuous. Method of measurement: PE and MH. Esfahan University of Medical Sciences Approved 2020-04-19 Institutional Research Ethics Committee, School of Medicine, Isfahan University of Medical Sciences School of Medicine, Isfahan University of Medical Sciences, Hezar-Jarib Ave Isfahan Isfehan Iran (Islamic Republic of)