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Trial - PACTR202102588777597


Column Value
Trial registration number PACTR202102588777597
Full text link
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Hussein AbdurRazzaq

Contact
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

haderazz05@ymail.com

Registration date
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-02-05

Recruitment status
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

(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.

Exclusion criteria
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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.

Number of arms
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

LAGOS STATE MINISTRY OF HEALTH

Inclusion age min
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

85

Countries
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Nigeria

Type of patients
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

No restriction on type of patients

Severity scale
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

0: No restriction on type of patients

Total sample size
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

240

primary outcome
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mortality

Notes
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 3

Arms
Last imported at : July 30, 2021, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"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"}]