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
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General information
اضافه شدن مرکز بیمارگیری و حجم نمونه پیش بینی شده
Increasing the number of the disease centers and predicted sample size
اضافه شدن مرکز بیمارگیری و حجم نمونه پیش بینی شدهIncreasing the number of the disease centers and predicted sample size
Increasing the number of the disease centers and predicted sample size
اضافه شدن مرکز بیمارگیری و حجم نمونه پیش بینی شده
Increasing the number of the disease centers and predicted sample sizeاضافه شدن مرکز بیمارگیری و حجم نمونه پیش بینی شده
Recruitment centers
#1
Name of recruitment center - English: Hagi Arbabi Selected center of covid19
Name of recruitment center - Persian: مرکز منتخب کووید ۱۹ حاجی اربابی
Full name of responsible person - English: Dr. Mohamdreza Salehi
Full name of responsible person - Persian: کتر محمدرضا فرد صالحی
Street address - English: Shahid Salimi 4th Avenue, Toos 74th Ave, Toos Blvd, Mashhad town
Street address - Persian: بلوارتوس، توس۷۴، شهید سلیمی ۴،
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: ۹۱۹۸۱۴۴۷۸
Phone: +98 51 3667 0016
Fax:
Email: Sinarezaei@yaho.com
Web page address:
Name of recruitment center - English: Hagi Arbabi Selected center of covid19 Name of recruitment center - Persian: مرکز منتخب کووید ۱۹ حاجی اربابی Full name of responsible person - English: Dr. Mohamdreza Salehi Full name of responsible person - Persian: کتر محمدرضا فرد صالحی Street address - English: Shahid Salimi 4th Avenue, Toos 74th Ave, Toos Blvd, Mashhad town Street address - Persian: بلوارتوس، توس۷۴، شهید سلیمی ۴، City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: ۹۱۹۸۱۴۴۷۸ Phone: +98 51 3667 0016 Fax: Email: Sinarezaei@yaho.com Web page address:
Protocol summary
Study aim
Evaluation of the efficacy of Gallecina® oral capsules, a hydrogen sulfide prodrug, as an adjuvant therapy in hospitalized patients with COVID-19
Design
a randomized placebo-controlled triple-blind phase 3 clinical trial on 148 patients with COVID-19
Settings and conduct
In the drug and placebo group, the capsules will be prescribed for a final period of 6 days. During treatment, SaO2 status will be monitored continuously once a day, and CT scan of the lung and CRP and CBC diff will be recorded at the beginning and end of the study. The patient's clinical signs and vital signs will be evaluated daily.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Hospitalized patients aged 18 to 65 years with definite diagnosis of SARS-CoV-2 infection based on PCR or detection of pulmonary involvement on CT scan.
Exclusion criteria:
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
Intervention groups
Consumption of Gallecina® capsules every 8 hours for 6 days
Main outcome variables
Time to improve clinical condition, time to normalize clinical symptoms, number of patients with change in oxygenation status, improved lung CT scan, change in quantitative CRP, number of deaths.
General information
Reason for update
Increasing the number of the disease centers and predicted sample size
Acronym
IRCT registration information
IRCT registration number:IRCT20201111049347N1
Registration date:2021-04-16, 1400/01/27
Registration timing:prospective
Last update:2021-04-27, 1400/02/07
Update count:2
Registration date
2021-04-16, 1400/01/27
Registrant information
Name
Sina Rezaei
Name of organization / entity
Samisaz pharmaceutical company
Country
Iran (Islamic Republic of)
Phone
+98 51 3541 3385
Email address
sina-rezaei@samisaz.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effectiveness of enriched garlic extract in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
248
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
North Khorasan University of Medical Sciences, Dowlat Blvd, bojnurd, 9414975516, Iran
City
Bojnord
Province
North Khorasan
Postal code
9414975516
Approval date
2021-01-11, 1399/10/22
Ethics committee reference number
IR.NKUMS.REC.1399.127
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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.
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital of Mashhad
Full name of responsible person
Dr. Saeed Hafizi Lotfabadi
Street address
Khorasan Razavi - Mashhad city - Torqabeh Shandiz intersection - Zafaranieh Boulevard - Dr. Ali Shariati Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
1589635427
Phone
+98 51 3541 3385
Email
saeedha917@gmail.com
2
Recruitment center
Name of recruitment center
Emam Hasan Hospital
Full name of responsible person
Dr. Mohammad Bagher Oghazian
Street address
Arkan road
City
Bojnurd
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3151 4055
Email
mohammadbagher_oghazian@yahoo.com
3
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Mehrdad Dargahi
Street address
Felestin Ave, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61338-33366
Phone
+98 61 3333 5935
Email
dargahi.m@ajums.ac.ir
4
Recruitment center
Name of recruitment center
Hagi Arbabi Selected center of covid19
Full name of responsible person
Dr. Mohamdreza Salehi
Street address
Shahid Salimi 4th Avenue, Toos 74th Ave, Toos Blvd, Mashhad town