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| Column | Value |
|---|---|
| Trial registration number | NCT04973462 |
|
Full text link
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
amalanas9@gmail.com |
|
Registration date
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
2021-07-22 |
|
Recruitment status
Last imported at : July 9, 2023, 8 a.m. Source : ClinicalTrials.gov |
Unknown |
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Study design
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: adults from 18 to 60 years old who signed informed consent; laboratory confirmed sars-cov-2 infection by real-time rt-pcr. chest computed tomography (ct) imaging-confirmed lung damage, including multiple small plaques and stromal changes in the lungs, which are obvious in the outer lung, or multiple ground-glass shadows and infiltration shadows in both lungs, although these changes might not be present in mild patients. patients with history of fever (axillary temperature more than 37°с) or respiratory symptoms. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
patients who are unsuitable or who cannot participate safely in the study, as judged by the principal investigator (pi). patients with serious liver disease (increase of liver transaminases enzymes). patients with severe renal impairment (denoted by increase serum urea & serum creatinine) or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. patients with severe anemia. women with a positive pregnancy test, ongoing pregnancy, or who are breastfeeding. patients with a history of allergy to medications or its metabolic components. patients who have not signed informed consent. patients participating in other clinical trials for covid-19 within 30 days prior to screening. patients participating in other clinical research in the past three months. |
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Number of arms
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Ain Shams University |
|
Inclusion age min
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
60 |
|
Countries
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Egypt |
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Type of patients
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Moderate/severe/critical disease at enrollment |
|
Severity scale
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
5: Moderate/severe/critical disease at enrollment |
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Total sample size
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
80 |
|
primary outcome
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Physicians Global Assessment to measure the baseline COVID-19 signs and symptoms |
|
Notes
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : July 23, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1315, "treatment_name": "Triazavirin", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 937, "treatment_name": "Oseltamivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}] |