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| Column | Value |
|---|---|
| Trial registration number | NCT04712279 |
|
Full text link
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
flavio.cadegiani@gmail.com |
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Registration date
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-01-15 |
|
Recruitment status
Last imported at : Jan. 6, 2023, 8 p.m. Source : ClinicalTrials.gov |
Unknown |
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Study design
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
unclear |
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Study aim
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: laboratory or clinically confirmed positive sars-cov-2 rtpcr test (androcov clinical scoring for covid-19 diagnosis1) within 7 days prior to randomization ≥18 years old laboratory confirmed positive sars-cov-2 rtpcr test within 7 days prior to randomization clinical status on the covid-19 ordinal scale (defined in section 5.1) of 1 to 3 subject (or legally authorized representative) gives written informed consent prior to performing any study procedures subject (or legally authorized representative) agree that subject will not participate in another covid-19 trial while participating in this study |
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
subject enrolled in a study to investigate a treatment for covid-19 require oxygen use, hospitalization or mechanical ventilation tachycardia (hr > 150 bpm) or hypotension (bp < 90/60 mmhg) patients who are allergic to the investigational product or similar drugs (or any excipients); subjects with qtcf > 450 ms subjects with uncontrolled medical conditions that could compromise participation in the study - uncontrolled hypertension (bp > 220/120 mmhg), uncontrolled hypothyroidism (tsh > 10 iu/l), uncontrolled diabetes mellitus (hba1c > 12%) alanine transaminase (alt) or aspartate transaminase (ast) > 5 times the upper limit of normal. estimated glomerular filtration rate (egfr) < 30 ml/min or requiring dialysis subject (or legally authorized representative) not willing or unable to provide informed consent |
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Number of arms
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Corpometria Institute |
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Inclusion age min
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
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Severity scale
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
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Total sample size
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
294 |
|
primary outcome
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
World Health Organization (WHO) Clinical Progression Scale [0 to 10; 0 = uninfected; 10 = death] |
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Notes
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : Jan. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "0.6mg/kg/day", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "1.0mg/kg/day", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |