Identifying the role of plasma cluster in the alleviation of symptoms in Covid-19 patients
Design
A control group with parallel groups, two-way blind, goal-based, phase 2 on 60 patients is included in the clinical investigation.
Settings and conduct
Outpatients with Covid-19 who do not require oxygen were referred to a specialist clinic for infectious illnesses in Bojnourd, as well as 16-hour Covid-19 testing centers.
Participants/Inclusion and exclusion criteria
Patients with mild to moderate Covid-19 symptoms who have had symptoms for at least 7 days and are between the ages of 18 and 50 should complete an informed consent form.
Intervention groups
After obtaining the code of ethics from the research ethics committee of North Khorasan University of Medical Sciences and also the code of clinical trial of researchers by referring outpatients with Covid-19 referred to the specialized clinic of infectious diseases and 16-hour test centers of Covid-19 in Bojnourd
By identifying all patients who with initial diagnosis of Covid-19 (based on clinical signs) who are eligible for home quarantine will be included in the study (the sampling method will be accessible and purposeful). Patients will begin treatment and be referred for PCR at the same time. If the test is negative, the patient is excluded from the study. Then 60 patients who meet the inclusion criteria will be included in the study and will be divided into two groups (intervention group (receiving plasma cluster and routine treatment are 30 people) and control group (routine treatment are 30 people)). The plasma cluster device is delivered to the patient with explanations and how to use it and is delivered from the patient for 8 consecutive hours after use.
Main outcome variables
Improving general condition and reducing the severity of symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191111045400N1
Registration date:2021-08-14, 1400/05/23
Registration timing:registered_while_recruiting
Last update:2021-08-14, 1400/05/23
Update count:0
Registration date
2021-08-14, 1400/05/23
Registrant information
Name
Mohammad Amin Younesieh Heravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7182
Email address
a.younessi7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Ionic Plasma Cluster Technology on the improvement of symptoms in patients with COVID-19
Public title
COVID-19 patients receiving with Ionic Plasma Cluster Technology
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate-grade Covid-19 patients
Since the start of their symptoms, a maximum of 7 days have elapsed.
Between the ages of 18 and 50,
Fill out the informed consent form and sign it.
Exclusion criteria:
Women who are pregnant or breastfeeding
Using immunosuppressive medications
Using sedatives and serotonin reuptake inhibitors
Addiction to drugs
underlying illness (chronic kidney and liver disease; brain and heart disease, pulmonary and hypertension; cancer, endocrine and metabolic diseases; thyroid disorders; immune deficiencies, Alzheimer's, multifocal failure, encephalopathy, and neuropathy)
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was double-blind so that participants and data analyzers were not aware of the contents of the intervention package.
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
Shahriyar st, north khorasan university of medical sciences
City
Bojnurd
Province
North Khorasan
Postal code
9417694780
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.NKUMS.REC.1400.041
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19 disease
Primary outcomes
1
Description
Improve symptoms based on checklist
Timepoint
Patients are monitored before the study and monitored 24 hours after the intervention. Then patients at weekly intervals for 4 weeks after the intervention in terms of clinical improvement by measuring body temperature, cough (zero or mild). And myalgia that is stable for at least 24 hours or the patient is hospitalized.
Method of measurement
Researcher checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 people receiving plasma cluster and routine treatment
Category
Treatment - Other
2
Description
Control group: Routine treatment equal to 30 people
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Special Clinic of Imam Reza Hospital
Full name of responsible person
mohammad amin younesi heravi
Street address
No. 5, North Khorasan University of Medical Sciences, Vice Chancellor for Research and Technology, Shahriar St. Bojnurd. Iran
City
Bojnurd
Province
North Khorasan
Postal code
9417694780
Phone
+98 58 3229 6769
Email
a.younessi7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Amir Amani
Street address
No.5, Shahriyar St, North Khorasan University of Medical Sciences, Bojnurd, Iran.
City
Bojnurd
Province
North Khorasan
Postal code
9417694780
Phone
+98 58 3229 6764
Email
amani76@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
mohammad amin younesi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Radiology
Street address
No.5, Shahriyar St, North Khorasan University of Medical sciences, Bojnurd, Iran
City
bojnurd
Province
North Khorasan
Postal code
9417694780
Phone
+98 58 3229 6769
Email
a.younessi7@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
mohammad reza taghavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
No.5, Shahriar St., Bojnurd, Iran
City
bojnurd
Province
North Khorasan
Postal code
9417694780
Phone
+98 58 3229 7182
Email
taghavimr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Salar Poorbarat
Position
Employee
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.5, Shahriar St., North Khorasan University of Medical Sciences, Bojnurd, Iran
City
bojnurd
Province
North Khorasan
Postal code
9417694780
Phone
+98 58 3229 6769
Email
salarpoorbarat98@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD