Protocol summary
-
Study aim
-
The effect of chitosan supplementation on clinical symptoms in patients with COVID-19
-
Design
-
The 80 eligible participants in the phase 2 clinical trial are randomly assigned to either the chitosan group or the placebo group. Patients will be divided into 2 equal groups using the block randomization method with 4 and 8 block sizes. Sealed envelope online software will be used for randomization.
-
Settings and conduct
-
Patients with coronavirus will be recruited from the Amir Almomenin hospital in Arak. The participant's assignment will be concealed from all participants and investigators, except for the study epidemiologist.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: age between 20 to 75 years, willingness to participate with written informed consent, diagnosis of coronavirus based on the PCR test. Exclusion criteria: current use of warfarin, presence of sensitivity to seafood.
-
Intervention groups
-
Intervention 1: receive 10 cc of the same 2.5% chitosan syrup (250 mg pharmacological grade chitosan) during the day, for 2 weeks.All syrups are prepared by the Barij Essence Pharmaceutical Co., Kashan, Iran.
-
Main outcome variables
-
Respiration rate; Chest CT scan; High sensitivity C-reactive protein; Erythrocyte sedimentation rate; Severity and number of coughs; Body temperature; Alanine aminotransferase activity; aspartate aminotransferase activity; Albumin.
General information
-
Reason for update
-
The change in application form of chitosan
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20210510051243N1
Registration date:
2021-05-25, 1400/03/04
Registration timing:
prospective
Last update:
2022-02-19, 1400/11/30
Update count:
1
-
Registration date
-
2021-05-25, 1400/03/04
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-05-31, 1400/03/10
-
Expected recruitment end date
-
2021-12-22, 1400/10/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effect of chitosan supplementation on clinical symptoms in patients with COVID-19
-
Public title
-
Chitosan supplementation and Coronavirus
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Age between 20 to 75 years,
Willingness to participate with written informed consent,
Diagnosis of coronavirus based on the PCR test.
Exclusion criteria:
Current use of warfarin,
Presence of sensitivity to seafood.
-
Age
-
From 20 years old to 75 years old
-
Gender
-
Both
-
Phase
-
2
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
80
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Patients will be randomly assigned to two groups. To do this, they will be divided into 2 equal groups by permuted block randomization method with 4 and 8 block sizes. The online Sealed envelope site will be used in such a way that the randomization sequence is generated by the mentioned method and a unique code is assigned to each of them. The randomization sequence will remain with the epidemiologist colleague, and patients will be assigned to the intervention and control groups, respectively, in accordance with the randomization sequence.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
This study will be done as a double blinded study. To blind the participants, a placebo that is similar in color, smell, taste, shape, size and weight to the main drug will be used. The outcomes will be assessed by a person who is unaware of assigning individuals to groups. The drugs will be provided to the researcher and the patient in similar packages, each of which has a unique code. At the end of the study, the decoding process is performed based on the randomization sequence and unique codes of each individual.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-04-28, 1400/02/08
-
Ethics committee reference number
-
IR.ARAKMU.REC.1400.016
Health conditions studied
1
-
Description of health condition studied
-
COVID-19 infection
-
ICD-10 code
-
U07.1
-
ICD-10 code description
-
COVID-19; virus identified
Primary outcomes
1
-
Description
-
Respiratory Rate
-
Timepoint
-
day 1 and day 14
-
Method of measurement
-
The number of breaths a person takes per minute
2
-
Description
-
Severity of lung involvement
-
Timepoint
-
day 1 and day 14
-
Method of measurement
-
Chest CT scan
3
-
Description
-
High-sensitivity C-reactive protein
-
Timepoint
-
Day 1 and day 14.
-
Method of measurement
-
Colorimetric method
4
-
Description
-
Erythrocyte Sedimentation Rate
-
Timepoint
-
Day 1 and day 14
-
Method of measurement
-
Colorimetric method
5
-
Description
-
Severity and number of coughs
-
Timepoint
-
Day 1 and day 14
-
Method of measurement
-
Cough visual analogue scale (VAS)
6
-
Description
-
Body temperature
-
Timepoint
-
Day 1 and day 14
-
Method of measurement
-
Clinical Thermometer
7
-
Description
-
Alanine aminotransferase Activity
-
Timepoint
-
Day 1 and day 14
-
Method of measurement
-
Colorimetric method
8
-
Description
-
Aspartate aminotransferase Activity
-
Timepoint
-
Day 1 and day 14
-
Method of measurement
-
Colorimetric method
9
-
Description
-
Superoxide dismutase Activity
-
Timepoint
-
Day 1 and day 14
-
Method of measurement
-
Colorimetric method
10
-
Description
-
Albumin
-
Timepoint
-
Day 1 and day 14
-
Method of measurement
-
Colorimetric method
11
-
Description
-
Death outcome
-
Timepoint
-
Day 14
-
Method of measurement
-
Percentage of fatal patients in two groups
Intervention groups
1
-
Description
-
Intervention group: receive 10 cc of the same 2.5% chitosan syrup (250 mg pharmacological grade chitosan) during the day, for 2 weeks.All syrups are prepared by the Barij Essence Pharmaceutical Co., Kashan, Iran.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Participants in the control group will receive 10 cc of identical placebo syrup (CMC with the same viscosity of chitosan syrup) during the day, for 2 weeks. All syrups are prepared by the Barij Essence Pharmaceutical Co., Kashan, Iran.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Arak University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable
-
Title and more details about the data/document
-
The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles.
-
When the data will become available and for how long
-
The non-identifiable individual participant data will become available after the publication of the relevant articles.
-
To whom data/document is available
-
The non-identifiable individual participant data will become available to other researchers in academic institutions.
-
Under which criteria data/document could be used
-
The non-identifiable individual participant data can only be used for research.
-
From where data/document is obtainable
-
The non-identifiable individual participant data will be obtainable by sending an e-mail to Dr. Hamid Abtahi (Email: abtahi@arakmu.ac.ir).
-
What processes are involved for a request to access data/document
-
Other researchers in academic institutions can send their request by e-mail to Dr. Hamid Abtahi (Email: abtahi@arakmu.ac.ir). The data will be sent to them after consulting and approving the research team.
-
Comments
-