Protocol summary
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Study aim
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Formulation of two natural products (syrup and solution) and evaluation of their efficacy and safety in COVID-19 patients
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Design
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This is a parallel 2-arm randomized, controlled, double-blind, single center study. 70 patients are enrolled and followed for 14 days
This study is a multi-center randomized, controlled, double-blind clinical trial with two parallel arms. 150 patients will be enrolled in the study and followed for 10 days.
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Settings and conduct
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This study will be carried out in some Iran University of Medical Sciences hospitals.
In the intervention group, 75 patients with COVID-19, in addition to standard recommended treatment, receive Crostop solution and Croguard syrup three times daily for 10 days. Also, 75 patients in the control group receive only the standard recommended treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 18-65 years old participants who highly suspected or confirmed cases of COVID-19 infection;
Exclusion criteria: History of drug allergy
Uncontrolled diseases including neuropsychiatric disorders, thyroid disorders, heart disease
Pregnancy; Breastfeeding
Renal or liver failure
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Intervention groups
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Intervention group in addition to receiving the standard treatment recommended by the National Committee, will receive Crostop solution 10 cc three times daily and Croguard syrup 30 cc three times daily for 10 days.
Patients in the control group will receive only the standard treatment.
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Main outcome variables
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Significant clinical recovery (composite): Clinical recovery up to 10 days from initiation of study treatment until normalization of fever (≤37.2 °C oral), respiratory rate (≤24/minute on room air), and oxygen saturation (>94% on room air), and alleviation of cough (mild or absent on a patient reported scale), sustained for at least 24 hours.
General information
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Reason for update
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Full name of the responsible person in the three recruitment centers was changed from Amir Hossein Jamshidi to Nader Tavakoli
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200316046792N1
Registration date:
2020-03-17, 1398/12/27
Registration timing:
registered_while_recruiting
Last update:
2020-03-24, 1399/01/05
Update count:
1
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Registration date
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2020-03-17, 1398/12/27
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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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2020-03-16, 1398/12/26
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Expected recruitment end date
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2020-05-20, 1399/02/31
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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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Formulation of two natural products (syrup and solution) and evaluation of their effects in patients with coronavirus disease 2019 (COVID-19): A randomized controlled trial
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Public title
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Effect of herbal syrup and solution in treatment of COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Laboratory-confirmed COVID-19 cases (2019-nCoV Real-Time RT-PCR ), regardless of the clinical manifestations and history of close contact
Both the men and women, aged between 18 to 65 years old
Signing informed written consent
Highly suspected cases of COVID-19 based on positive findings of chest CT scan
Exclusion criteria:
5 days or more after the onset of illness
Pregnancy
Breastfeeding
History of drug allergy
Complicated cases with bacterial infection
Patients in recovery phase
Critical and severe cases such as ARDS
Clinical evidence for respiratory insufficiency at the time of hospitalization (SaO2 ≤90% or PaO2 < 8 kPa) in the patient breathing room air without oxygen therapy
Comorbidities (e.g. renal failure, liver failure, CHF, cerebrovascular and cardiovascular major diseases, chronic pulmonary disease, malignancy, endocrine and metabolic diseases, any immunodeficiency disorders such as AIDS, encephalopathy, neuropathy )
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
150
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomized in a 1:1 ratio into one of the treatment groups and standard of care group using computer generated randomization plan. The date and time of randomization will be recorded. Allocation concealment will be done with the sealed envelope method
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The treatment assignment will remain unknown until the patient is randomized. Physicians who treat patients and the patients will not be blinded. Radiologists, physicians who assess outcomes and the statistician analyzing the data all will be blinded
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-16, 1398/12/26
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Ethics committee reference number
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IR.IUMS.REC.1398.1399
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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U07.1
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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Response to the treatment (Significant clinical improvement)
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Timepoint
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At baseline and on the third, fifth, seventh, and tenth days after starting the treatment
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Method of measurement
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According to the clinical, paraclinical and laboratory findings. Clinical improvement: normalization of the body temperature (≤37.2 ° C), respiratory rate (≤24 breaths per minute), oxygen saturation (> 94% at room temperature) and cough (zero or mild) that persist for at least 24 hours. Cough will measure on a qualitative scale based on the patient's report . Other outcome variables will measure during clinical examination
2
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Description
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Complications of the treatment
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Timepoint
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Daily, until the tenth day
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Method of measurement
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Interview and patient's record
Secondary outcomes
1
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Description
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Duration of hospitalization
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Timepoint
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End of the treatment
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Method of measurement
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Patient's medical record
2
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Description
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Mortality
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Timepoint
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End of the treatment
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Method of measurement
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Patient's medical record (Clinical outcome)
Intervention groups
1
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Description
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Intervention group: Hospitalized patients will receive 10 cc Corostop solution and 30 cc Coroguard syrup three times daily for 10 days in addition to receiving standard treatments recommended by the corona county committee.
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Category
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Treatment - Drugs
2
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Description
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Control group: Hospitalized patients will receive standard treatment according to the national guidelines for the treatment of COVID-19
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Outpatients (self-quarantine at their home) will receive 10 cc Corostop solution and 30 cc Coroguard syrup three times daily for 10 days in addition to receiving standard treatments recommended by the corona county committee.
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Category
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Treatment - Drugs
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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Iran University of Medical Sciences
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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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Public
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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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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is 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
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Title and more details about the data/document
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The study results will be published. Also the study protocol and statistical analysis will be considered.
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When the data will become available and for how long
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One year after completion of the study, data will be published and available
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To whom data/document is available
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With the financial backing permission, data may be made available to the physicians and academic researchers and institutions.
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Under which criteria data/document could be used
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Other researchers are permitted to included the results in their systematic reviews and metaanalysis
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From where data/document is obtainable
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For this you may ask Amirhossein Janshidi through jamshidiam@yahoo.com
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What processes are involved for a request to access data/document
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After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks
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Comments
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