Rapid treatment of Covid-19 patients hospitalized and reduction of workload of medical staff
Design
In this cross-sectional study, 300 patients with Covid-19 admitted (in three hospitals) were randomly enrolled. Underlying variables such as age, sex, BMI, and type of underlying disease are extracted from patient records at the beginning of the study. The trial has a control group with parallel and double-blind groups. The patient's blood oxygen level is measured at the beginning of the study. The data obtained from this study are analyzed using SPSS software version 26 as well as Graph Pad software version 9.
Settings and conduct
patients after evaluation and confirmation of Covid 19 and having the inclusion conditions,Entered the study and the solution (H2O8) is used by three methods of inhalation ,Sublingual and rectal for used in the three mentioned hospitals.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patient with Covid-19 and positive PCR
Age over 18 years
patient Hospitalized
Exclusion criteria:
patient or guardian unwillingness to continue cooperation
Intervention groups
The study was performed on 300 patients admitted to three hospitals of Shahid Labafinejad, Dr. Masih Daneshvari, and Emam Ali (AS) in Karaj, which were selected by simple random sampling and obtained with their informed consent. In this study, in which 100 patients were randomly selected from each center, the solution (H2O8) was used in three methods: inhalation, sublingual and rectal. 50 patients in all three methods of inhalation, sublingual and rectal, and 50 patients They will be in three groups as a control group
Main outcome variables
Evaluation and measurement of patients' blood oxygen levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190215042716N2
Registration date:2022-05-30, 1401/03/09
Registration timing:retrospective
Last update:2022-05-30, 1401/03/09
Update count:0
Registration date
2022-05-30, 1401/03/09
Registrant information
Name
navid shafigh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 3378
Email address
n.shafigh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Anionic Oxygen on O2 Saturation of COVID-19 Patients: A Multicenter Study
Public title
Effects of Anionic Oxygen on O2 Saturation of COVID-19 Patients: A Multicenter Study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with Covid-19 and PCR positive
Age over 18 years
Hospitalized
Exclusion criteria:
No treatment of the patient or guardian to continue cooperation
Age
From 18 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected by simple random sampling from among patients admitted to three hospitals
The equivalent of 300 Covid-19 patients will be included in this study (100 patients in each hospital by:50 patients in all three methods of inhalation, sublingual and rectal and 50 patients in three control groups)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University od Medical Sciences
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-04-24, 1401/02/04
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.036
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid19 disease
Primary outcomes
1
Description
blood oxygen levels
Timepoint
Every 2 hours
Method of measurement
Using a pulse oximeter
Secondary outcomes
1
Description
LDH measurement
Timepoint
two hours
Method of measurement
Through a blood test
Intervention groups
1
Description
Intervention group: Inhalation method of using solution (H2O8) in vials containing 5 ml,By nebulizer with particles less than 3 microns, every two hours for 60 hours that enters the patient's lungs.
Category
Treatment - Drugs
2
Description
Intervention group: Rectal method: 25 ml anal (rectal), used four times a day.(This method is used for patients with serious condition, including intubated patients)
Category
Treatment - Drugs
3
Description
Intervention group: Sublingual method: oral solution (H2O8) should be swallowed by the patient in the mouth for 2 to 4 minutes and then gently swallowed.Blood oxygen levels should be measured every two hours.
Category
Treatment - Drugs
4
Description
Control group: Patients in all three methods of inhalation, sublingual and rectal and 50 patients in three control groupsCommunity Verified icon
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Full name of responsible person
Navid Shafigh
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran