Trial registration number
|
IRCT20201229049873N1 |
Full text link
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/53791
|
First author
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Mehreban Sadeghi
|
Contact
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
sadeghi@skums.ac.ir
|
Registration date
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2021-05-23
|
Recruitment status
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Blind label
|
Center
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
|
Study aim
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patients with Covid-19 with acute respiratory symptoms between the ages of 18 and 60 who test positive for the SARS-CoV-19 virus by RT-PCR or by CT scan. Lung scan (subpleural lung involvement, bilateral circumference, and more than one area).
Saturated oxygen is below 88%
Respiratory rate more than 24 times per minute
high CRP and D-dimer level, also ferritin above 1000
Lymphopenia with a count of less than 1100
|
Exclusion criteria
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patients who have a positive test for PPD, HCV, HBS
Patients Have a history of neurodegenerative diseases such as multiple sclerosis
Patients with heart failure, hypertension, and infections other than Covid 19 infection.
|
Number of arms
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Shahre-kord University of Medical Sciences
|
Inclusion age min
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
|
Inclusion age max
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
60
|
Countries
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Severe disease at enrollment
|
Severity scale
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
6: Severe disease at enrollment
|
Total sample size
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
40
|
primary outcome
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Changes in paraclinical outcomes
Blood oxygen levels
Duration of hospitalization
|
Notes
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 2/Phase 3
|
Arms
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 650, "treatment_name": "Infliximab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|