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Trial - NCT04768179


Column Value
Trial registration number NCT04768179
Full text link
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04768179

First author
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Jackson Mukonzo, PhD

Contact
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

mukojack@yahoo.co.uk

Registration date
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

2021-02-24

Recruitment status
Last imported at : Feb. 3, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - provision of signed and dated informed consent form - willingness to comply with all study procedures and availability over the study duration *patients aged above 18years to 64 years - pcr positive for sars-cov-2 (covid-19) from any of the moh covid-19 accredited testing laboratories - moderately ill covid-19 patients score 3(hospitalized with no oxygen therapy) to 4 (hospitalized with oxygen by mask or nasal prongs) according to the who ordinal scale for clinical improvement which translates to moderate to severe covid-19 patients according to the ministry of health uganda covid-19 disease category.

Exclusion criteria
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

- participants with known hypersensitivity to ivermectin - clinical diagnosis of severe renal and hepatic impairment. - pregnancy or breast feeding. - co-treatment with either strong cytochrome p-450 inducers including: rifampicin, carbamazepine and barbiturates or inhibitors: isoniazid, clofazimine that might potentially affected ivermectin disposition and clinical outcomes - co-morbidities including asthma - loa loa as assessed by travel history to angola, cameroon, chad, central african republic, congo, dr congo, equatorial guinea, ethiopia, gabon, nigeria and sudan in the last 4 years - persons clinically diagnosed with and receiving treatment for any diathesis and pud - active participation in another clinical trial

Number of arms
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Makerere University

Inclusion age min
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

64

Countries
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

490

primary outcome
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

SARS COV 2 Viral clearance;World Health Organization COVID-19 ordinal improvement score

Notes
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "3-dayIVM 200 mcg/kg/day/14-day 75mgASA/day + standard of care", "treatment_id": 1416, "treatment_name": "Aspirin+ivermectin", "treatment_type": "Coagulation modifiers+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "3-day Ivermectin 600 mcg/kg/day/14-day 75mgASA/day + standard of care", "treatment_id": 1416, "treatment_name": "Aspirin+ivermectin", "treatment_type": "Coagulation modifiers+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"}]