| Trial registration number
|
IRCT20211004052664N1 |
Full text link
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/59137
|
First author
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Dr. Afshin Zarghi
|
Contact
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Mpajouhesh@sbmu.ac.ir
|
Registration date
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2021-10-06
|
Recruitment status
Last imported at : Dec. 30, 2021, 7:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Open label
|
Center
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
|
Study aim
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Laboratory covfirmation of COVID-19 virus by RT-PCR or imaging findings consistent with COVID-19
Moderate-severity disease (respiratory rate <30 per minute, oxygen saturation > 94% or pulmonaru infiltration < 50% in both lungs)
Age above 14 years
Willingness to participate in this study
|
Exclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Immunocompromised patients
Pregnancy
Consumption of effective drugs in the treatment of COVID-19 in this clinical course
History of severe hypersensitivity or anaphylactic shock
|
Number of arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Shahid Beheshti University of Medical Sciences
|
Inclusion age min
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
14
|
Inclusion age max
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
|
Countries
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Moderate disease at enrollment
|
Severity scale
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
3: Moderate disease at enrollment
|
Total sample size
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
80
|
primary outcome
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Body temperature
Respiratory rate (per minute)
Oxygen saturation
|
Notes
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 3
|
Arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|