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Trial - NCT04459286


Column Value
Trial registration number NCT04459286
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04459286

First author
Last imported at : Nov. 3, 2021, 1:30 p.m.
Source : ClinicalTrials.gov

Adeniyi Olagunju, PhD

Contact
Last imported at : Nov. 3, 2021, 1:30 p.m.
Source : ClinicalTrials.gov

aeolagunju@oauife.edu.ng

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-07-07

Recruitment status
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - willingness and ability to provide written informed consent - at least 18 and not more than 75 years of age at study entry - sars-cov-2 infection confirmed by pcr test within 4 days before randomization - currently symptomatic (fever or chills, cough, myalgia, sore throat, shortness of breath, or new onset of anosmia or ageusia) and at covid-19 isolation and treatment centre

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- inability to take orally administered medication or food - known hypersensitivity to study medication - pregnant or lactating (unless practicing exclusive replacement feeding for the entire study duration) - participation in any other interventional trial for covid-19 (observational study co-enrollment allowed) - concurrent treatment with other agents with actual or possible direct-acting antiviral activity against sars-cov-2 less than 24 hours prior to study drug dosing - concurrent use of agents with known or uncertain interaction with study drugs, including ritonavir - requiring mechanical ventilation at screening - alanine aminotransferase (alt) or aspartate aminotransferase (ast) above 5 times upper limit of normal (uln) - creatinine clearance below 50 ml/min using the cockcroft-gault formula for participants above 18 years of age

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Obafemi Awolowo University

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

75

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Nigeria

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Nov. 3, 2021, 1:30 p.m.
Source : ClinicalTrials.gov

57

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Difference in SARS-CoV-2 AUC;Time to SARS-CoV-2 negativity;Time to clinical improvement

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

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

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1647, "treatment_name": "Atazanavir+nitazoxanide+ritonavir", "treatment_type": "Antivirals+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"}]