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IRCT20201111049347N1 IRCT 2021-04-16 Samisaz Pharmaceutical company Effectiveness of enriched garlic extract in patients with COVID-19 Evaluation of the efficacy of Gallecina® oral capsules, a hydrogen sulfide prodrug, as an adjuvant therapy in hospitalized patients with COVID-19: a randomized placebo-controlled triple-blind clinical trial 2021-04-21 anticipated 248 Complete https://irct.ir/trial/52245 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients in two groups of drugs and placebo is done by preparing a randomization list from randomization.com using Permuted Blocked Randomization method. In this method, blocks of ten are used for two treatments A (drug) and B (placebo). Due to the possible loss of samples during the study, the number of patients is estimated to be 30% more than the calculated sample size and is placed in the software. The number of blocks is obtained by dividing the estimated sample size by ten. The output file shows the assignment of drug or placebo treatment to patient number 1 to the last patient sample size, Blinding description: The medicine and placebo are prepared with the same appearance and in the same package with the relevant code. For patients who meet the inclusion criteria, Gallecina® is prescribed. The study package is provided to the nurse in the ward. However, neither the nurse nor the researcher is aware of the contents of the package when receiving the medication. After recording the data, the results are provided in the form of code to the person who performs the data analysis. Analysis is performed based on the provided codes. Decrypting the codes is done after analysis by a person who knows how to place patients in control and intervention groups. 3 Covid-19. Intervention 1: Intervention group: Based on the patient's clinical status, and treatment criteria, the following antiviral and anti-inflammatory drugs may be prescribed to the patient: Interferon beta-1a with a dose of 44 micrograms by subcutaneous injection every other day in the amount of 5 to 7 doses of Favipiravir with a dose: the first day of 1800 mg every 12 hours and from the following days 800 mg every 12 hours for 10 days up to a maximum of 14 days. Persistent oxygen demand despite supportive therapy and SpO2 between 90-93%, corticosteroids can be given in low doses: Dexamethasone 8 mg intravenously daily for up to 10 days. Or oral prednisolone tablets 0.5mg / kg for a maximum of 10 days. Remdesivir IV: 200 mg as a single dose on day 1, followed by 100 mg once daily. Total duration is 5 days. To the above drug treatment, one Gallecina® capsule (containing processed garlic extract) prepared by Sami Saz Pharmaceutical Company is added every 8 hours for 6 days. Intervention 2: Control group: Based on the patient's clinical status, and treatment criteria, the following antiviral and anti-inflammatory drugs may be prescribed to the patient: Interferon beta-1a with a dose of 44 micrograms by subcutaneous injection every other day in the amount of 5 to 7 doses of Favipiravir with a dose: the first day of 1800 mg every 12 hours and from the following days 800 mg every 12 hours for 10 days up to a maximum of 14 days. Persistent oxygen demand despite supportive therapy and SpO2 between 90-93%, corticosteroids can be given in low doses: Dexamethasone 8 mg intravenously daily for up to 10 days. Or oral prednisolone tablets 0.5mg / kg for a maximum of 10 days. Remdesivir IV: 200 mg as a single dose on day 1, followed by 100 mg once daily. Total duration is 5 days. To the above drug treatment, one placebo capsule (has all the specifications of Gallecina® drug but does not have the active ingredient Gallecina®) prepared by Sami Saz Pharmaceutical Company is added every 8 hours for 6 days. Yes - There is a plan to make this available What will be shared: All details of the study will be published in the form of a scientific article When: 6 months after the end of the study To whom: All interested Conditions: Preserving the intellectual rights of publishers in order to promote the study Where to obtain: Refer to the general accountability officer of the trial How to obtain: 6 months after the end of the study and after the publication of the article via the following email : sina-rezaei@samisaz.com Comments:
public Dr. Sina Rezaei
461,No. 9,North Talash Boulevard,Toos Industrial City,Mashhad,Iran
Mashhad Iran (Islamic Republic of) 9185175545 +98 51 3541 3385 sina-rezaei@samisaz.com Samisaz Pharmaceutical Co. scientific Dr. Mohammad Ansari Mohseni
461,No. 9,North Talash Boulevard,Toos Industrial City,Mashhad,Iran
Mashhad Iran (Islamic Republic of) 9185175545 +98 51 3541 3385 m-ansari@samisaz.com Samisaz Pharmaceutical Co Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Hospitalized patients with definite diagnosis of SARS-CoV-2 infection based on PCR or detection of pulmonary involvement on CT scan. Hospitalized patients aged 18 to 65 years old 18 years 65 years Both History of garlic allergy and garlic-derived products Pregnancy and lactation period Low patient pressure at the beginning of the study (below 120/80) Malignancy, Immune deficiency, Alzheimer's, Multiple organ failure, Encephalopathy B34.2 Coronavirus infection, unspecified Treatment - Drugs Placebo Intervention group: Based on the patient's clinical status, and treatment criteria, the following antiviral and anti-inflammatory drugs may be prescribed to the patient: Interferon beta-1a with a dose of 44 micrograms by subcutaneous injection every other day in the amount of 5 to 7 doses of Favipiravir with a dose: the first day of 1800 mg every 12 hours and from the following days 800 mg every 12 hours for 10 days up to a maximum of 14 days. Persistent oxygen demand despite supportive therapy and SpO2 between 90-93%, corticosteroids can be given in low doses: Dexamethasone 8 mg intravenously daily for up to 10 days. Or oral prednisolone tablets 0.5mg / kg for a maximum of 10 days. Remdesivir IV: 200 mg as a single dose on day 1, followed by 100 mg once daily. Total duration is 5 days. To the above drug treatment, one Gallecina® capsule (containing processed garlic extract) prepared by Sami Saz Pharmaceutical Company is added every 8 hours for 6 days. Control group: Based on the patient's clinical status, and treatment criteria, the following antiviral and anti-inflammatory drugs may be prescribed to the patient: Interferon beta-1a with a dose of 44 micrograms by subcutaneous injection every other day in the amount of 5 to 7 doses of Favipiravir with a dose: the first day of 1800 mg every 12 hours and from the following days 800 mg every 12 hours for 10 days up to a maximum of 14 days. Persistent oxygen demand despite supportive therapy and SpO2 between 90-93%, corticosteroids can be given in low doses: Dexamethasone 8 mg intravenously daily for up to 10 days. Or oral prednisolone tablets 0.5mg / kg for a maximum of 10 days. Remdesivir IV: 200 mg as a single dose on day 1, followed by 100 mg once daily. Total duration is 5 days. To the above drug treatment, one placebo capsule (has all the specifications of Gallecina® drug but does not have the active ingredient Gallecina®) prepared by Sami Saz Pharmaceutical Company is added every 8 hours for 6 days. The time to recovery, defined as the from the time of randomization and start of treatment to the first day of recovery: not hospitalized, hospitalized with not requiring supplemental oxygen and/or no longer requiring ongoing medical care (used if hospitalization was extended for infection-control reasons). Timepoint: From the time of randomization. Method of measurement: Number of days. Time to normalize fever (in hours): From the time of randomization and start of treatment, to be normalized fever. The criteria for normalization is: Fever - ≤36.9°C or -axilla, ≤37.2 °C oral. Timepoint: every 6 hour. Method of measurement: Body temperature. Time to improve shortness of breath (in hours): From the time of randomization and start of treatment, to be normalized respiratory rate. The criteria for normalization is: Respiratory rate - ≤24/minute on room air. Timepoint: every 6 hour. Method of measurement: Respiratory rate. Time to normalize oxygen saturation (in hours): From the time of randomization and start of treatment, to be normalized oxygen saturation. The criteria for normalization is: Oxygen saturation - >94% on room air. Timepoint: every 6 hour. Method of measurement: O2 saturation measurement. Time to improve cough (in hours): From the time of randomization and start of treatment, to be improved cough. The criteria for normalization is: Cough - mild or absent on a patient-reported scale of severe, moderate, mild, absent. Timepoint: every 6 hour. Method of measurement: Cough rate. Number of patients with changes in oxygen delivery status. The categories are as follows: 1. hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control reasons); 2. hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (Covid-19–related or other medical conditions); 3. hospitalized, requiring any supplemental oxygen; 4. hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 5, hospitalized, receiving invasive mechanical ventilation. Timepoint: End of the study. Method of measurement: Number of days. Improved lung CT scan. Timepoint: Before the intervention and the end of the study. Method of measurement: CT Scan. Change in measured quantitative CRP. Timepoint: Before the intervention and the end of the study. Method of measurement: blood test. Mortality rate. Timepoint: End of the study. Method of measurement: Number of patients who died. Incidence of adverse effects: Acute respiratory failure, hypotension, viral pneumonia, acute renal failure, anemia, decreased hemoglobin, decreased GFR, increased creatinine, hyper or hypoglycemia, increased LFT. Timepoint: End of the study. Method of measurement: Incidence of the adverse effect. Samisaz Pharmaceutical company Approved 2021-01-11 Ethics Committee of North Khorasan University of Medical Sciences North Khorasan University of Medical Sciences, Dowlat Blvd, bojnurd, 9414975516, Iran Bojnord North Khorasan Iran (Islamic Republic of)