A multi-centre, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir for the treatment of COVID-19 in Lagos State: study protocol for a randomized controlled trial.

BACKGROUND: The coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that was first identified in Wuhan, Hubei, China, in December 2019. It was recognized as a pandemic by the World Health Organization on 11 March 2020. Outbreak forecasting and mathematical modelling suggest that these numbers will continue to rise. Early identification of effective remedies that can shorten the duration and severity of illness is critical for Lagos State, which is the epi-centre of the disease in Nigeria. METHODS: This is a multi-centre, randomized, double-blind placebo-controlled superiority trial. The study investigates the efficacy of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir added on to standard of care compared to standard of care only in patients with COVID-19 disease. The primary outcome is the clinical status of patients measured using a 7-point ordinal scale at day 15. Research participants and clinicians will be blinded to the allocated intervention. Outcome measures will be directly assessed by clinicians. Statistical analysis will be done by a team blinded to the identity and allocation of research participants. Data analysis will follow intention-to-treat methods, using R software. DISCUSSION: The current study is of strategic importance for Lagos State in potentially curbing the health, social and economic burden of COVID-19 disease. Should the current study demonstrate that either of the three intervention drugs is more efficacious than standard therapy alone, the State Ministry of Health will develop an evidence-based guideline for the management of COVID-19 in Lagos State. The findings will also be shared nationally and with other states which may lead to a standardized national guideline for the treatment of COVID-19 in Nigeria. TRIAL REGISTRATION: Pan African Clinical Trials Register PACTR202004801273802 . Registered prospectively on April 2, 2020.

Risk of congenital cardiovascular anomalies in patients with non-syndromic orofacial cleft: A preliminary case-control study.

BACKGROUND: Orofacial clefts (OCs) are one of the most common craniofacial anomalies and are reported to be associated with congenital cardiovascular anomalies (CCAs). However, there is paucity of data in African populations on the risk of CCAs in OC patients compared to the general population. AIMS: This study aims to determine the odds of congenital cardiovascular anomalies in patients with OC compared to the general population. SUBJECTS AND METHODS: A case-control study design was used. Case subjects were non-syndromic OC subjects, while controls were non-syndromic subjects without OC. All subjects were thoroughly assessed by a pediatric cardiologist for CCAs; and grouped by OC phenotypic type (cleft lip and/or alveolus, cleft lip and palate, cleft palate only and Tessier cleft). Statistical analysis was done using STATA version 14 (College Station, Texas), and significance was placed at P value ≤0.05. RESULTS: A total of 120 subjects (60 cases and 60 controls) were enrolled in the study. In total, 23.3% of the subjects had CCAs. Among the case group, 40% had CCAs compared to 6.7% in the control group. Patent foramen ovale (18.3%) and atrial septal defects (10.0%) were the most common type of CCAs in cases, respectively. Further, cases had significantly higher odds of CCAs compared to controls (OR: 9.3; CI: 2.8, 39.4). CONCLUSIONS: Our finding reveals that the odds of CCAs are significantly higher in patients with OC than the general population. Future studies could assess the effect of CCAs on surgical outcome.

Emerging Trends in the Epidemiological Pattern of Head and Neck Cancers in Lagos, Nigeria.

BACKGROUND: Unfortunately, despite an increase in medical knowledge, survival rates of head and neck cancers (HNCs) have not been observed to improve greatly. This is true, especially in tumors located in obscure primary sites or late presentation. AIM: The purpose of this study is to assess the epidemiologic pattern of HNCs and to evaluate its emerging trends and patterns in Lagos state. SUBJECTS AND METHODS: A retrospective study was conducted from 2003 to 2013 that analyzed histologically diagnosed cases of HNC at the Pathology Departments of the two tertiary teaching hospitals in Lagos. Data analysis was performed using the Statistical Package for the Social Sciences (version 20) statistical software. RESULTS: One thousand and eighty-three cases of head and neck malignancies were recorded. A female: male ratio of 1.01:1 was reported with mean age of 39.6 (standard deviation 21.1) years. The oral cavity was the most affected anatomic site (21.2%, 230/1083) in the period under review. Malignant epithelial tumors accounted for 72% (779/1083) of cases seen. Carcinomas were the most common histological variant seen (67%, 726/1083) and squamous cell carcinoma accounted for 58% (421/726) of carcinomas recorded. Oral cavity malignancies (21.8%, 118/540) were the most common in males while thyroid malignancies (28.5%, 155/543) were the most seen in females. In children (≤15 years), the most common histologic findings were carcinomas (42.3%; 77/182) and retinoblastomas (23.6%; 43/182). CONCLUSION: Epithelial malignancies were the most common malignancy in the study, and the oral cavity appears to be the increasingly predominant site for HNCs. A changing pattern in gender predominance, age distribution, and frequency with histological variants and anatomical sites was also observed in this study.