| Trial registration number
|
IRCT20120216009045N4 |
Full text link
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/55980
|
First author
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Akbar Fotouhi
|
Contact
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
afotouhi@tums.ac.ir
|
Registration date
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2021-12-01
|
Recruitment status
Last imported at : Feb. 9, 2022, 3:12 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Blind label
|
Center
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
|
Study aim
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patient with Covid-19 coronavirus (confirmation of diagnosis by positive PCR test)
Severe pneumonia due to COVID-19
Age 70 - 18 years
Conscious consent of the patient or her guardian in cases that the patient is not conscious.
|
Exclusion criteria
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Receiving interleukin production inhibitors such as Octemra
Patients with a history of HIV + or any history of immunodeficiency
Patient with active bacterial pneumonia
Primary or metastatic lung cancer
History of any cancer or malignancy
Chronic lung diseases include: pulmonary fibrosis, bronchiectasis, asthma
smoking
Previous thoracic and lung surgery
Patients with hypernatremia
Intubated patients
|
Number of arms
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Tehran University of Medical Sciences
|
Inclusion age min
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
|
Inclusion age max
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
70
|
Countries
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Critical disease at enrollment
|
Severity scale
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
8: Critical disease at enrollment
|
Total sample size
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
40
|
primary outcome
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Interleukin 6
Measurement of serum TNF_α before and after the intervention.
|
Notes
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 1
|
Arms
Last imported at : Dec. 1, 2021, 11:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 2069, "treatment_name": "5% hypertonic saline", "treatment_type": "Nasal spray", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|