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| Column | Value |
|---|---|
| Trial registration number | IRCT20200408046987N2 |
|
Full text link
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
|
|
First author
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
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Contact
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
dr.niaee@gmail.com |
|
Registration date
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
2020-11-07 |
|
Recruitment status
Last imported at : Dec. 15, 2020, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Completed |
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Study design
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
RCT |
|
Allocation
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
Randomized |
|
Design
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
Parallel |
|
Masking
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
Blind label |
|
Center
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
single-center |
|
Study aim
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
Patients who test positive for COVID-19 by a commercially available Test Patients ≥ 20 but < 65 years of age with a temperature (oral) of 38°C and patients 65 - 80 years of age with a temperature (oral) of 37.8°C Patients with 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment: Cough Sore throat Headache Nasal congestion Feeling feverisho Body aches and pains Fatigue (tiredness) |
|
Exclusion criteria
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
patients with Immuno deficiency patients under any other antiviral therapy |
|
Number of arms
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
5 |
|
Funding
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
Akam Tejarat Fartak Farasoo |
|
Inclusion age min
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
20 |
|
Inclusion age max
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
80 |
|
Countries
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
Iran |
|
Type of patients
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
No restriction on type of patients |
|
Severity scale
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
0: No restriction on type of patients |
|
Total sample size
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
150 |
|
primary outcome
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
Chest image(CT scan) hospitalization time CBC CRP |
|
Notes
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
|
|
Phase
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
Phase 2/Phase 3 |
|
Arms
Last imported at : Nov. 8, 2020, midnight Source : Iranian Registry of Clinical Trials (IRCT) |
[{"arm_notes": "400 mcg/kg (ivermectin), 400/60 (sofosbuvir+daclatasvir)", "treatment_id": 1710, "treatment_name": "Daclatasvir+ivermectin+sofosbuvir", "treatment_type": "Antivirals+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "400 mcg/kg in day1 followed by 200 mcg/kg in day 3 and day 5 (ivermectin), 400/60 (sofosbuvir+daclatasvir)", "treatment_id": 1710, "treatment_name": "Daclatasvir+ivermectin+sofosbuvir", "treatment_type": "Antivirals+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "400 mcg/kg in day1 followed by 200 mcg/kg in day 3 and day 5 (ivermectin), 400/60 (sofosbuvir+daclatasvir), standard of care", "treatment_id": 1710, "treatment_name": "Daclatasvir+ivermectin+sofosbuvir", "treatment_type": "Antivirals+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |