| Trial registration number
|
IRCT20120703010178N25 |
Full text link
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/57280
|
First author
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Afshin Zarghi
|
Contact
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
urm@sbmu.ac.ir
|
Registration date
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2021-08-09
|
Recruitment status
Last imported at : Jan. 20, 2022, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Open label
|
Center
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
|
Study aim
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Confirmed COVID-19, based on reverse transcriptase-polymerase chain reaction (rt-PCR)
Patients with mild to moderate COVID-19
Within 48 hours of the onset of the symptoms
|
Exclusion criteria
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Age younger than 18 years old
Diagnosis of COVID-19 based on clinical criteria without positive rt-PCR results
The onset of symptoms more than 48 hours
Patients with severe to critical COVID-19
Immunocompromised state
Receiving any antiviral or anti-inflammatory drug
Lactation and pregnancy
Liver enzymes 3 times higher than the normal range
Psychotic disorders
Platelet count below 50,000
Hemoglobin less than 10 grams per deciliter
|
Number of arms
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Shahid Beheshti University of Medical Sciences
|
Inclusion age min
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
|
Inclusion age max
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
|
Countries
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Mild/moderate disease at enrollment
|
Severity scale
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2: Mild/moderate disease at enrollment
|
Total sample size
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
|
primary outcome
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Body temperature
Systolic blood pressure
Diastolic blood pressure
Respiratory rate
Pulse rate
level of oxygen saturation in the peripheral circulation
|
Notes
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 3
|
Arms
Last imported at : Aug. 9, 2021, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 671, "treatment_name": "Interferon beta 1a", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|