Protocol summary
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Study aim
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Evaluation of Allicin derivatives capsule efficacy as an adjuvant therapy for patients with COVID-19
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Design
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Randomized, parallel group trial with blinded outcome assessment on 25 patients. Randomization was done using online website (randomization.com)
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Settings and conduct
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The study will be done at Internal ward, Imam Reza Hospital, Mashhad. Medication and Placebo will be coded by researcher. Randomization will be done using online website (randomization.com). The participants (patients with COVID-19), Physician and nurses who evaluates the patients will be blinded to the group allocation. Allicin derivatives capsules and Placebo have the same color, shape and size.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients diagnosis with COVID-19; Age between 18-70 year old. Non-inclusion criteria: breastfeeding or pregnancy; Allergy to Onion or Garlic; History of recent surgery or digestive tract bleeding
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Intervention groups
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Intervention group: Administration of Allicin derivatives capsule (90 mg) twice per day for 14 days plus the standard treatment for COVID-19.
Control group: Administration of Placebo twice per day for 14 days plus the standard treatment for COVID-19.
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Main outcome variables
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Time to full recovery;
Body temperature;
O2 saturation
General information
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Reason for update
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Due to the removal of one of the colleagues from the collaboration and mistakes in recording some information such as sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200610047722N1
Registration date:
2020-07-07, 1399/04/17
Registration timing:
registered_while_recruiting
Last update:
2021-03-29, 1400/01/09
Update count:
2
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Registration date
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2020-07-07, 1399/04/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2020-07-22, 1399/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the efficacy of Allicin derivatives capsule and Placebo as an adjuvant for patients with COVID-19: A double-blind randomized placebo controlled clinical trial
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Public title
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ٍEffect of Allicin derivatives capsule in treatment of patients with new Coronavirus
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with RT-PCR positive for SARS-CoV-2 , clinical sign and symptoms (fever, cough and myalgia) and CT scan indicate COVID-19 positive.
Age 18-70
Sign consent form
Exclusion criteria:
History of allergic reaction to Allicin
History of allergic reaction to Garlic or Onion
History of low blood pressure or gastrointestinal tract bleeding
Low blood pressure and the beginning of study (lower that 120/80 mmHg)
Patients with immune deficiency disorders (patients undergo chemotherapy, organ or bone marrow transplants and patients with autoimmune disease)
No need to use ventilator during the study
Unable to swallow the oral medication
Pregnancy
Breastfeeding
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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0
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
25
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation to study groups including intervention and placebo will be done using online randomization website (randomization.com). This website will allocate the patients (100) into both medication and placebo groups with the same sample size. The numbers will be produced in a row (between 1-100) for both medication and placebo groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Medication and placebo will be coded by the researcher. Allicin derivatives capsules and Placebo have the same color, shape and size; so participants, physicians and nurses who evaluate the results are blinded to the intervention and groups allocation.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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No
Ethics committees
1
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Ethics committee
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Approval date
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2020-06-06, 1399/03/17
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Ethics committee reference number
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IR.MUMS.REC.1399.289
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.2
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ICD-10 code description
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COVID-19, virus not identified
2
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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Body temperature
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Timepoint
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Before starting the study and every day during the study
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Method of measurement
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Thermometer
2
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Description
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O2 saturation
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Timepoint
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Before starting the study and every day during the study
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Method of measurement
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pulse oximeter
3
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Description
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Time to recovery
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Timepoint
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Everyday until the full recovery
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Method of measurement
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WHO criteria for COVID-19
Secondary outcomes
1
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Description
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Lymphocytopenia
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Timepoint
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Before starting the study, one week and two week later
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Method of measurement
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Cell Counter (CBC)
2
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Description
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C-reactive protein
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Timepoint
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Before starting the study, one week and two week later
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Method of measurement
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C-RP kit
3
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Description
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Serious side effects
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Timepoint
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Before starting the study and everyday during the study
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Method of measurement
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questionnaire
Intervention groups
1
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Description
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Intervention group: Standard treatment for COVID-19 plus Allicin derivatives capsule (90 mg) twice per day for 14 days
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Category
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Treatment - Drugs
2
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Description
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Control group: Standard treatment for COVID-19 plus Placebo twice per day for 14 days
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hossein Nik Tale
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available