Browsing by Author "Adebiyi, A. O."

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A randomized, open-label trial of combined nitazoxanide and atazanavir/ritonavir for mild to moderate COVID-19
(Frontiers Media, 2022-09) Fowotade, A.; Bamidele, F.; Egbetola, B.; Fagbamigbe, A. F.; Adeagbo, B. A.; Adefuye, B. O.; Olagunoye, A.; Ojo, T. O.; Adebiyi, A. O.; Olagunju, O. I.; Ladipo, O. T.; Akinloye, A.; Onayade, A.; Bolaji, O. O.; Rannard, S.; Happi, C.; Owen, A.; Olagunju, A.
Background: The nitazoxanide plus atazanavir/ritonavir for COVID-19 (NACOVID) trial investigated the efficacy and safety of repurposed nitazoxanide combined with atazanavir/ritonavir for COVID-19. Methods: This is a pilot, randomized, open-label multicenter trial conducted in Nigeria. Mild to moderate COVID-19 patients were randomly assigned to receive standard of care (SoC) or SoC plus a 14-day course of nitazoxanide (1,000 mg b.i.d.) and atazanavir/ritonavir (300/100 mg od) and followed through day 28. Study endpoints included time to clinical improvement, SARS-CoV-2 viral load change, and time to complete symptom resolution. Safety and pharmacokinetics were also evaluated (ClinicalTrials.gov ID: NCT04459286). Results: There was no difference in time to clinical improvement between the SoC (n = 26) and SoC plus intervention arms (n = 31; Cox proportional hazards regression analysis adjusted hazard ratio, aHR = 0.898, 95% CI: 0.492–1.638, p = 0.725). No difference was observed in the pattern of saliva SARS-CoV- 2 viral load changes from days 2–28 in the 35% of patients with detectable virus at baseline (20/57) (aHR = 0.948, 95% CI: 0.341–2.636, p = 0.919). There was no significant difference in time to complete symptom resolution (aHR = 0.535, 95% CI: 0.251–1.140, p = 0.105). Atazanavir/ritonavir increased tizoxanide plasma exposure by 68% and median trough plasma concentration was 1,546 ng/ml (95% CI: 797–2,557), above its putative EC90 in 54% of patients. Tizoxanide was undetectable in saliva. Conclusion: Nitazoxanide co-administered with atazanavir/ritonavir was safe but not better than standard of care in treating COVID-19. These findings should be interpreted in the context of incomplete enrollment (64%) and the limited number of patients with detectable SARS-CoV-2 in saliva at baseline in this trial.
A randomized, open-label trial of combined nitazoxanide and atazanavir/ritonavir for mild to moderate COVID-19
(Frontiers Media SA, 2022) Fowotade, A.; Bamidele, F.; Egbetola, B.; Fagbamigbe, A. F.; Adeagbo, B. A.; Adefuye, B. O.; Olagunoye, A.; Ojo, T. O.; Adebiyi, A. O.; Olagunju, O. I.; Ladipo, O. T.; Akinloye, A.; Onayade, A.; Bolaji, O. O.; Rannard, S.; Happi, C.; Owen, A.; Olagunju, A.
Background: The nitazoxanide plus atazanavir/ritonavir for COVID-19 (NACOVID) trial investigated the efficacy and safety of repurposed nitazoxanide combined with atazanavir/ritonavir for COVID-19. Methods: This is a pilot, randomized, open-label multicenter trial conducted in Nigeria. Mild to moderate COVID-19 patients were randomly assigned to receive standard of care (SoC) or SoC plus a 14-day course of nitazoxanide (1,000 mg b.i.d.) and atazanavir/ritonavir (300/100 mg od) and followed through day 28. Study endpoints included time to clinical improvement, SARS-CoV-2 viral load change, and time to complete symptom resolution. Safety and pharmacokinetics were also evaluated (ClinicalTrials.gov ID: NCT04459286). Results: There was no difference in time to clinical improvement between the SoC (n = 26) and SoC plus intervention arms (n = 31; Cox proportional hazards regression analysis adjusted hazard ratio, aHR = 0.898, 95% CI: 0.492–1.638, p = 0.725). No difference was observed in the pattern of saliva SARS-CoV2 viral load changes from days 2–28 in the 35% of patients with detectable virus at baseline (20/57) (aHR = 0.948, 95% CI: 0.341–2.636, p = 0.919). There was no significant difference in time to complete symptom resolution (aHR = 0.535, 95% CI: 0.251–1.140, p = 0.105). Atazanavir/ritonavir increased tizoxanide plasma exposure by 68% and median trough plasma concentration was 1,546 ng/ml (95% CI: 797–2,557), above its putative EC90 in 54% of patients. Tizoxanide was undetectable in saliva. Conclusion: Nitazoxanide co-administered with atazanavir/ritonavir was safe but not better than standard of care in treating COVID-19. These findings should be interpreted in the context of incomplete enrollment (64%) and the limited number of patients with detectable SARS-CoV-2 in saliva at baseline in this trial.
Efficacy and safety of nitazoxanide plus atazanavir/ritonavir for the treatment of moderate to severe COVID-19 (NACOVID): A structured summary of a study protocol for a randomised controlled trial
(BioMed Central Ltd, 2021) Olagunju, A.; Fowotade, A.; Olagunoye, A.; Ojo, T. O.; Adefuye, B. O.; Fagbamigbe, A. F.; Adebiyi, A. O.; Olagunju, O. I.; Ladipo, O. T.; Akinloye, A.; Adeagbo, B. A.; Onayade, A.; Bolaji, O. O.; Happi, C.; Rannard, S.; Owen, A.
Objectives: To investigate the efficacy and safety of repurposed antiprotozoal and antiretroviral drugs, nitazoxanideand atazanavir/ritonavir, in shortening the time to clinical improvement and achievement of SARS-CoV-2 polymerase chain reaction (PCR) negativity in patients diagnosed with moderate to severe COVID-19. Trial design: This is a pilot phase 2, multicentre 2-arm (1:1 ratio) open-label randomised controlled trial. Participants: Patients with confirmed COVID-19 diagnosis (defined as SARS-CoV-2 PCR positive nasopharyngeal swab) will be recruited from four participating isolation and treatment centres in Nigeria: two secondary care facilities (Infectious Diseases Hospital, Olodo, Ibadan, Oyo State and Specialist State Hospital, Asubiaro, Osogbo, Osun State) and two tertiary care facilities (Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Osun State and Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State). These facilities have a combined capacity of 146-bed COVID-19 isolation and treatment ward. Inclusion criteria: Confirmation of SARS-CoV-2 infection by PCR test within two days before randomisation and initiation of treatment, age bracket of 18 and 75 years, symptomatic, able to understand study information and willingness to participate. Exclusion criteria include the inability to take orally administered medication or food, known hypersensitivity to any of the study drugs, pregnant or lactating, current or recent (within 24 hours of enrolment) treatment with agents with actual or likely antiviral activity against SARS-CoV-2, concurrent use of agents with known or suspected interaction with study drugs, and requiring mechanical ventilation at screening. Intervention and comparator: Participants in the intervention group will receive 1000 mg of nitazoxanide twice daily orally and 300/100 mg of atazanvir/ritonavir once daily orally in addition to standard of care while participants in the control group will receive only standard of care. Standard of care will be determined by the physician at the treatment centre in line with the current guidelines for clinical management of COVID-19 in Nigeria. Main outcome measures: Main outcome measures are: (1) Time to clinical improvement (defined as time from randomisation to either an improvement of two points on a 10-category ordinal scale (developed by the WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection) or discharge from the hospital, whichever came first); (2) Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at days 2, 4, 6, 7, 14 and 28; (3) Temporal patterns of SARS-CoV-2 viral load on days 2, 4, 6, 7, 14 and 28 quantified by RT-PCR from saliva of patients receiving standard of care alone versus standard of care plus study drugs. Randomisation: Allocation of participants to study arm is randomised within each site with a ratio 1:1 based on randomisation sequences generated centrally at Obafemi Awolowo University. The model was implemented in REDCap and includes stratification by age, gender, viral load at diagnosis and presence of relevant comorbidities. Blinding: None, this is an open-label trial. Number to be randomised (sample size): 98 patients (49 per arm). Trial status: Regulatory approval was issued by the National Agency for Food and Drug Administration and Control on 06 October 2020 (protocol version number is 2.1 dated 06 August 2020). Recruitment started on 9 October 2020 and is anticipated to end before April 2021. Trial registration: The trial has been registered on ClinicalTrials.gov (July 7, 2020), with identifier number NCT0445 9286 and on Pan African Clinical Trials Registry (August 13, 2020), with identifier number PACTR202008855701534. Full protocol: The full protocol is attached as an additional file which will be made available on the trial website. In the interest of expediting dissemination of this material, the traditional formatting has been eliminated, and this letter serves as a summary of the key elements in the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).
Falls and outcomes amongst old people in rural dwellings
(Association of Resident Doctors (ARD), University College Hospital (UCH), Ibadan, Nigeria., 2009) Adebiyi, A. O.; Uchendu, O. C.; Ikotun, O. T.; Oluleye, O. W.; Olukotun, O. P.
Background: Falls are the leading cause of injury deaths among people 65 years and older. This study gives an insight into the prevalence of falls among older people and how they occur in a rural setting in Nigeria. Methods: A community based survey of 210 consenting old people aged 65 years and above selected using a multi-stage sampling technique was done. Study instrument was a semi-structured interviewer administered questionnaire and visual acuity was tested using Snellens chart. Results: Incidence of falls was 21.4%. Of those who had falls, 86.7% were walking while 11.1% were either sitting or running when it occurred. The nature of the fall was tripping in 44.4%, slipping in 35.6% and hitting an object in 17.8% of cases. Consequences of falls included pain 48.9%, bruises 22.2%, lacerations 13.3% and fractures 11.1%. Females had more falls than males; 23.8% vs 19.0%, p = 0.40. Major injuries resulting from falls also occurred more frequently amongst females than males; 30.7% vs. 15.0%, p = 0.3. History of diabetes and alcohol use increased the odds of falling (OR 4.1, 95% CI 1.0 – 16.0; OR 2.2, 95% CI 1.0 – 4.6 respectively). Being in a monogamous marriage and having normal sight were protective of having falls (OR 0.4, 95% CI 0.2 – 0.9; OR 0.4, 95% CI 0.2 – 0.9 respectively). Conclusion: Falls often occur from tripping and slipping while females are more likely to have major injuries. Risk factors for falls were alcohol use and diabetes while having normal sight and being monogamous were protective. Prevention should aim at a life course approach to addressing these intrinsic and extrinsic factors.
Perceived effectiveness of graphic health warnings as a deterrent for smoking initiation among adolescents in selected schools in southwest Nigeria
(BioMed Central Ltd, 2016) Adebiyi, A. O.; Uchendu, O. C.; Bamgboye, E.; Ibitoye, O.; Omotola, B.
Background: There has been a sustained increment in young people initiating smoking in low middle income countries like Nigeria. Health warnings on cigarette packages are a prominent source of health information and an effective means of communicating specific disease risks to adolescents and young adults alike. This study evaluated the perceived effectiveness of selected graphic warnings on smoking initiation amongst in-school adolescents. Methods: This was a cross-sectional study conducted amongst secondary school students aged 13–17years in Igbo-Ora, Nigeria. A two-stage sampling technique with the school classes as the final sampling unit was used to select the students. An interviewer assisted questionnaire was used to obtain information on students demographic characteristics and their perception of graphic warnings using four images from the pictorial health warning galleries of the World Health Organization showing: ‘cigarette smoking causes cancer of the airways, harms children, causes stroke and causes impotence respectively'. Results: A total of 544 senior secondary students were included in this study with a male female ratio of 0.8:1. Of those interviewed, 40 (7.4 %) indicated that they had ever considered smoking, nine (1.7 %) responded that they had ever smoked and two students indicated that they were current smokers. With all the images, fear was the dominant emotion expressed by the respondents. This was expressed by 307 (56.4), 215 (39.5), 203 (37.3) and 228 (41.9 %) respondents to images 1, 2, 3, and 4 respectively. Furthermore, 76.7, 44.7, 58.5 and 62.1 % of respondents felt Images 1, 2, 3 and 4 respectively will to a large extent prevent people from initiating smoking. There was no association between perceived effectiveness and gender. However, those younger than 15 years rated images on cancer of the airway and impotence as probably effective to a larger extent than did those who were 15 years and older (p = 0.032). Conclusion: Introduction of graphic health warnings, especially with an imagery depicting cancer and impotence may influence non-smokers to remain abstinent. Therefore, this study provides a template for a future policy-relevant study on graphic health warning in Nigeria.
Willingness of tobacco retailers in Oyo State to participate in tobacco control programmes
(E.U. European Publishing, 2018) Uchendu, O.; Adebiyi, A. O.; Adeyera, O.
INTRODUCTION Tobacco control strategies have not incorporated retailers, despite being the focus by the tobacco industry to promote its products. Few studies exist on their possible roles in tobacco control. This study, therefore, assessed retailer awareness of tobacco control laws and willingness to be involved in control activities. METHODS A cross sectional study was carried out on all 218 tobacco retailers in Ibarapa Central and Ibarapa East Local Government Areas of Oyo State. The willingness of tobacco retailers to participate in tobacco-use control was evaluated using a questionnaire. RESULTS The majority of the respondents were females (95%), and 30-39 years old with respect to age. Almost two-thirds (65%) of the respondents reported the sale of tobacco as a profitable business, and a third reported that their income would decrease if they stopped tobacco sales. Up to 35% of retailers were aware of laws restricting smoking in public places and 45% aware of a ban on the sale of tobacco products to minors. Retailers were willing to: support anti-tobacco legislations (84%), counsel smokers to quit smoking (84%), and display anti-tobacco messages in their shops (77%). CONCLUSIONS The sale of tobacco products is a profitable venture for retailers. Willingness to participate in tobacco control was high among the retailers. There is a need to raise awareness and co-opt tobacco retailers as change agents in tobacco control efforts.