Trial registration number
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PACTR202102588777597 |
Full text link
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14661
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First author
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Hussein AbdurRazzaq
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Contact
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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haderazz05@ymail.com
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Registration date
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-02-05
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Recruitment status
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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(1) Provide written informed consent prior to initiation of any study procedures
(2) Understand and agree to comply with planned study procedures
(3) Agree to the collection of oropharyngeal swabs and venous blood per protocol
(4) Be male or non-pregnant female adult =18 years of age at time of enrolment
(5) Have laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen no more than 72 hours prior to randomisation.
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Exclusion criteria
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. American Society of Anaesthesiologists (ASA) class 3 and above.
2. Stage 4 severe chronic kidney disease or requiring dialysis (eGFR < 30)
3. Pregnant or breast feeding.
4. Anticipated transfer to another facility which is not a study site within 72 hours.
5. Participants with known haematological diseases (G6PD deficiency)
6. Participants with chronic liver and kidney disease and reaching end-stage.
7. Participants with arrhythmia and chronic heart disease.
8. Participants known to have retinal disease or hearing loss.
9. Participants known to have a mental illness.
10. Skin disorders (including rash, dermatitis, psoriasis).
11. Allergy to Ivermectin or its analogues.
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Number of arms
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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LAGOS STATE MINISTRY OF HEALTH
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Inclusion age min
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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85
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Countries
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Nigeria
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Type of patients
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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No restriction on type of patients
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Severity scale
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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0: No restriction on type of patients
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Total sample size
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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240
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primary outcome
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mortality
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Notes
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 3
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Arms
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "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"}]
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