Evaluation of therapeutic effects of ozone chemotherapy on the respiratory status of patients with covid 19
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. For randomization, the block randomization method will be used. The method of assigning people to each block is using a table of random numbers (from top to bottom)
Settings and conduct
The present study is a clinical trial study on 60 patients with COVID who will be selected from two centers of Ziaian Hospital in Tehran and Imam Ali Hospital in Karaj.
30 patients undergo ozone chemotherapy for 10 sessions. The procedure is open label, meaning that patients will know which group they will be in.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1.Age over 18 years;
۲. Definitive Cavid_19 disease (SARS_COV_2 PCR POSITIVE);
3. Patients who are hospitalized in the course of the disease;
4. Spo2 <90%;
5. CT scans of the lungs show evidence of involvement in Covid 19 disease;
6. Not being admitted to the ICU on the first visit to start ozone therapy
-Exclusion criteria
1. Age less than 18 years;
2. Pregnancy;
3. Breastfeeding;
4. Intubation patient at the first visit to start ozone therapy;
5. Albumin below 3.5;
6. Presence of underlying diseases (liver, kidney, hyperthyroidism, hypothyroidism, heart disease);
Intervention groups
30 patients undergo ozone hemotherapy for 10 sessions. The patient's blood was taken in the first session 120 cc and combined with 120 cc of ozone gas and from the second session onwards 240 cc in the blood bag and with 240 Combine cc of ozone gas and inject it again into the patient. The first session is performed daily and the fifth session is performed every other day.
Main outcome variables
The effect of ozone chemotherapy on the respiratory status of patients with COVID
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200504047298N4
Registration date:2022-03-05, 1400/12/14
Registration timing:prospective
Last update:2022-03-05, 1400/12/14
Update count:0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Zeinab Siami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4602 2136
Email address
z.siami@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-15, 1400/12/24
Expected recruitment end date
2022-05-14, 1401/02/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Ozone Hemotherapy on the Respiratory Condition of Patients with Sever Covid with the Control Group
Public title
Investigating the effectiveness of Ozone Hemotherapy on the respiratory condition of patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Getting infected with covid 19 disease (SARS_COV_2 PCR POSITIVE)
Patients who are hospitalized in the course of the disease
Spo2 under 90%
On the CT scan of lung, the evidences of covid 19 are presented
Not being admitted at the ICU, on the first visit, at the start of ozone therapy
Exclusion criteria:
Age less than 18 years
Pregnancy
Breastfeeding
Intubated patient on the first visit at the start of ozone therapy
Album below 3.5
Presence of underlying diseases (liver, kidney, hyperthyroidism, hypothyroidism, heart disease)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the total sample size, 60 people will be used to maintain the balance between the two groups in random blocking methods. Therefore, 10 blocks of 6 will be formed, and in each block, three in the intervention group and three will be in the control group. Allocating individuals to each block uses random numbers table (from top to bottom).
The blinding is in the form of Open Label, that means patients will be informed of their groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is open label, meaning that, patients will be informed of their groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Committee for Ethics in Biomedical Research
30 patients are undergoing Hemotherapy with ozone for 10 sessions. The patient’s blood was taken at the first session to the amount of 120 cc and it is combined with 120 cc of gas. While from the second session, the amount of 240 cc in the blood bag was taken, and it combines with 240 cc ozone gas and it injects back into the patient. The first four sessions are daily, but from the fifth session, it is performed in the form of every other day.
Category
Treatment - Other
2
Description
Control group: 30 patients with nearly similar conditions of the intervention group however only receive standard treatment.