Determining the effect of oral methadone on improving shortness of breath in patients with covid-19
Design
The sample size was estimated to be 84 people. Shit is divided into two groups of control and control (42 people in each group).
Settings and conduct
The study population is patients admitted to Sabzevar Vasei Hospital with a diagnosis of Covid-19.
All hospitalized patients with diagnosis of Covid 19 who are in phase two (moderate or severe) of the disease are eligible to participate in the study. The researcher prepares a solution of methadone 1 mg / ml and glucose solution 1 mg / ml and according to the patient's code and his / her control or intervention group, one of the solutions is assigned to the patient. Drug and placebo solutions are marked with two letters A and B by the researcher. The nature of the two solutions will be unknown to the sampler, patient and statistical consultant.
The researcher mixes one cc of solution (a or b) with 100 cc of water at 12 noon after completing the vas and borg questionnaire with the cooperation of the patient and is given orally to the patient. This process is performed on three consecutive days and on the fourth day, the questionnaires are completed without prescribing medication. Every day, the patient's file is checked and the nursing report is recorded 24 hours before the study and the medication regimen and possible changes as well as the patient's spo2 level are recorded. If the patient's respiratory condition worsens or the inclusion criteria change, they will be excluded from the study..
Participants/Inclusion and exclusion criteria
Patients with Covid-19 who are in phase two (moderate and severe),
Lack of Selection: Renal, pulmonary and liver failure. Pregnant and lactating women with a history of addiction or methadone use
Intervention groups
Intervention and control group
Main outcome variables
Improve breathing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210820052236N1
Registration date:2021-10-22, 1400/07/30
Registration timing:registered_while_recruiting
Last update:2021-10-22, 1400/07/30
Update count:0
Registration date
2021-10-22, 1400/07/30
Registrant information
Name
Fatemeh Ghardashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5501 8342
Email address
f2.ghardashi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect oral methadone on improvement dyspnea in patients with Covid-19
Public title
The effect oral methadone on improvement dyspnea in patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient admitted to covid-19 wards of Sabzevar Vasei Hospital,
Positive PCR test result
Willingness to cooperate (written consent)
Phase 2 of Covid disease -19 (moderate or severe)
Exclusion criteria:
Cigarette and drug addiction
History of drug use or methadone therapy
Liver failure
Breastfeeding and pregnant women
Pulmonary insufficiency
Kidney failure
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be in the form of permutation blocks. In this way, the patient will be placed in one of two control or intervention groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The researcher prepares a solution of methadone 1 mg / ml and glucose solution 1 mg / ml and according to the patient's code and his / her control or intervention group, one of the solutions is assigned to the patient. Drug and placebo solutions are marked with two letters A and B by the researcher. The nature of the two solutions will be unknown to the sampler, patient and statistical consultant.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Biomedical Research Ethics Committee
Street address
Nuclear Martyrs Boulevard. Campus of Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Approval date
2021-09-20, 1400/06/29
Ethics committee reference number
IR.MEDSAB.REC.1400.036
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
B34.2
ICD-10 code description
Use this code when COVID-19 has been confirmed by laboratory testing irrespective of severity of clinical signs or symptoms. Use additional code, if desired, to identify pneumonia or other manifestations.
Primary outcomes
1
Description
Improvement of respiration is measured quantitatively by improving the percentage of peripheral blood oxygen, which is measured by pulse oximetry, and qualitatively by increasing the score of the vas and borg questionnaires.
Timepoint
Daily at a specific time (12 noon) for up to 4 days
Method of measurement
Percentage of peripheral blood oxygen with pulse oximetry. Respiratory quality with vas and borg questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
2
Description
Control group:
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Vasei
Full name of responsible person
Ezat Samadipour
Street address
Shohadae hastei Blvd.Sabzevar University of Medical Sciences Campus
City
Sabzevar
Province
Razavi Khorasan
Postal code
961387311
Phone
+98 51 4401 8342
Email
f2.ghardashi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad hosian Saghi
Street address
Shohadae hastei Blvd. Sabzevar University of Medical Sciences Campus
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 8300
Email
rmedsab@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fatemeh Ghardashi
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Management of research and technology in the health system
Street address
Shohadae hastei Blvd. Sabzevar University of Medical Sciences Campus
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 8342
Email
f2.ghardashi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ezat Samadipour
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Shohadaehastei Blvd. Campus of Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 8342
Email
samadipourez@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fatemeh Ghardashi
Position
Fculty
Latest degree
Ph.D.
Other areas of specialty/work
Health R&T Managment
Street address
Shohade hasti Blvd. Campus of Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 8342
Email
f2.ghardashi@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The documents will be published in the form of scientific articles in prestigious scientific journals
When the data will become available and for how long
6 months after sampling
To whom data/document is available
Researchers, faculty and the general public
Under which criteria data/document could be used
In order to increase the knowledge of care management of patients with Covid-19, the data will be made available to others after the publication of the article.
From where data/document is obtainable
Vice Chancellor for Research and Technology, Sabzevar University of Medical Sciences. Dr. Saghi
What processes are involved for a request to access data/document
Sabzevar University of Medical Sciences Vice Chancellor for Research, expert in research projects of the university