| Trial registration number
|
IRCT20220618055209N1 |
Full text link
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/64248
|
First author
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Dr Alireza Kamali
|
Contact
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
alikamaliir@yahoo.com
|
Registration date
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2022-06-23
|
Recruitment status
Last imported at : July 6, 2023, 4 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Blind label
|
Center
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
multi-center
|
Study aim
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Medium to critical grade Covid-19 without intubation with respiratory symptoms
Positive PCR test
Need to receive more than 4 to 6 liters of oxygen per minute with a simple mask with non-rebreathing storage bag
Apache score less than 25
18 to 75 years
Absence of acute asthma, and other lung diseases such as pulmonary edema, heart and lung disease
|
Exclusion criteria
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Reluctance to participate in the study
Do not perform any of the evacuation situations
Intubation during study
Transfer the patient to the ward
Death
|
Number of arms
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Arak University of Medical Sciences
|
Inclusion age min
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
|
Inclusion age max
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
75
|
Countries
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Critical disease at enrollment
|
Severity scale
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
8: Critical disease at enrollment
|
Total sample size
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
90
|
primary outcome
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Breathing rate
Oxygen saturation percentage
Blood carbon dioxide pressure
Blood pH
Blood bicarbonate
Need to get oxygen
Number of coughs
|
Notes
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 3
|
Arms
Last imported at : June 23, 2022, 8:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 1013, "treatment_name": "Postural positioning", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|