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Column | Value |
---|---|
Trial registration number | IRCT20160625028622N2 |
Full text link
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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First author
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Contact
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Info@qums.ac.ir |
Registration date
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2022-01-16 |
Recruitment status
Last imported at : June 19, 2022, 7:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Completed |
Study design
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
RCT |
Allocation
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Randomized |
Design
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Parallel |
Masking
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Blind label |
Center
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
single-center |
Study aim
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Treatment |
Inclusion criteria
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
A positive PCR test for a new coronavirus Having an involvement in a CT scan of the lungs and a definitive diagnosis by the treating physician that the person is infected Therefore, people whose confirmed results of this virus are confirmed and who have 2 or more of the following symptoms will be studied in the following study: Including: Patients with pulmonary involvement of 50% and above (severe cases) (sometimes closed At the discretion of the physician and the patient's condition, lower lung involvement is also a criterion for hospitalization (moderate cases), 90 <O2 saturation <94 (moderate to severe cases) and o2 saturation <90 (severe cases), sub-cough symptoms (visual assessment criteria) Sore throat (patient report), headache (patient report), nasal congestion (patient report), fever (temperature above 37.3), body aches and pains (patient report), fatigue (patient report) |
Exclusion criteria
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Patients suspected of having a bacterial respiratory infection at the beginning of the study Patients with serious chronic diseases. Pregnant women Patients with HIV Patients with cancer Patients with vascular disease Patient with endocrine disease Patients who become infected during studying |
Number of arms
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2 |
Funding
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Qazvin University of Medical Sciences |
Inclusion age min
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
18 |
Inclusion age max
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
70 |
Countries
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Iran |
Type of patients
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Moderate/severe disease at enrollment |
Severity scale
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
4: Moderate/severe disease at enrollment |
Total sample size
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
50 |
primary outcome
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Cough chest pain shortness of breath O2 saturation level number of days with tachypnea fever fibrinogen levels di-dimer ROS laboratory indicators duration of possible need for use of mechanical lung ventilation systems survival rate of patients |
Notes
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
|
Phase
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Phase 2 |
Arms
Last imported at : Jan. 16, 2022, 12:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
[{"arm_notes": "", "treatment_id": 93, "treatment_name": "Antioxidant therapy", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |