| Trial registration number
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NCT04944082 |
Full text link
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04944082
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First author
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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Maiada K. Hashem
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Contact
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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2021-06-29
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Recruitment status
Last imported at : June 8, 2023, noon
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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unclear
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Study aim
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- adult, hospitalized severe covid-19 patients; both genders; given informed consent
(covid-19 infection confirmed by pcr, severe illness is defined as patients with spo2
≤94% on room air, including patients on supplemental oxygen).
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Exclusion criteria
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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- patients under 18 years old, pregnant ladies, advanced renal diseases (cr. clearance <
30 ml/hr), raised liver enzymes> 3 folds of normal, arrhythmia.
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Number of arms
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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Assiut University
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Inclusion age min
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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None
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Type of patients
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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60
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primary outcome
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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1- Improvement in level of oxygenation;2- Need for ventilator support;3- Length of hospital stay;4- Development of complication;5- Mortality
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Notes
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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Phase 4
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Arms
Last imported at : July 1, 2021, 2:30 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 2300, "treatment_name": "Ivermectin+remdesivir", "treatment_type": "Antiparasitics+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]
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