Preliminary Study on Open Labelled Randomized Controlled Trial of the Safety and Efficacy of Hydroxychloroquine and Chloroquine Phosphate for the Treatment of Persons Infected with 2019 Coronavirus Disease in Nigeria.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a causative agent of COVID-19 is a leading cause of ill-health and deaths worldwide. Currently, COVID-19 has no known widely approved therapeutics. Thus, the need for effective treatment. OBJECTIVES: We investigated the safety and efficacy of two (2) therapeutic agents; chloroquine phosphate (CQ), 2- hydroxychloroquine (HCQ) and a control (standard supportive therapy) among hospitalized adults with COVID-19. METHODS: The clinical trial was done in accordance to the World Health Organization master protocol for investigational therapeutics for COVID-19. Atotal of 40 participants with laboratory-confirmed positive COVID-19 were enrolled. Blood samples and oropharyngeal (OP) swabs were obtained on days 1,3,15 and 29 for safety and efficacy assessments. RESULTS: The baseline demographics showed that the median ages in years (range) were 45 (31-57) in CQ, 45 (36.5-60.5) in HCQ, 43 (39.5-67.0) and 44.5 (25.3-51.3) in the control (P<0.042).At randomization, seven (7) participants were asymptomatic, thirty-three (33) had mild symptoms, eight (8) had moderate symptoms while three (3) had severe symptoms. The average day of conversion to negative COVID-19 was 15.5 days for CQ, 16 days for HCQ and 18 days for the control(P=0.036). CONCLUSION: The safety assessment revealed no adverse effect of the drugs in COVID-19 patients after treatment. These findings proved that chloroquine and hydroxychloroquine are effective for the treatment of COVID-19 among hospitalized adults. It also confirmed that they are safe.

CONTEXTE: Le coronavirus du syndrome respiratoire aigu sévère 2 (SARS-CoV-2),agentcausaldelaCOVID-19, est l'unedes principales causes demaladie et de décès dans le monde. À l'heure actuelle, il n'existe aucun traitement largement approuvé pour la COVID-19. Ainsi, ilya un besoin de traitement efficace. OBJECTIFS: Nous avons étudié l'innocuité et l'efficacité de deux (2) agents thérapeutiques, le phosphate de chloroquine (CQ) et l'hydroxychloroquine (HCQ), ainsi qu'un groupe témoin (traitement de soutien standard) chez des adultes hospitalisés atteints de la COVID-19.MÉTHODES: L'essai clinique a été mené conformément au protocole maître de l'Organisation mondiale de la santé pour les thérapeutiques à l'étude de la COVID-19. Au total, 40 participants atteints de la COVID-19, confirmée en laboratoire, ont été in scrits. Des échantillons de sang et des prélèvements oropharyngés (PO) ont été effectuésauxjours1,3,15et29pourévaluerl'innocuitéetl'efficacité. RÉSULTATS: Les données démographiques initiales ont révélé que l'âge médian en années (plage) était de 45 (31-57) pour le groupe CQ, de 45 (36,5-60,5) pour le groupe HCQ, de 43 (39,5-67,0) et de 44,5 (25,3-51,3) pour le groupe témoin (P<0,042). À la randomisation, sept (7) participants étaient asymptomatiques, trente-trois (33) présentaient des symptômes bénins, huit(8) avaient des symptômes modérés, tandis que trois(3) avaient des symptômes graves. Le jour moyende conversionentest COVID-19 négatif était de 15,5 jours pour le groupe CQ, de 16 jours pour le groupe HCQ et de 18 jours pourle groupe témoin (P=0,036). CONCLUSION: L'évaluation de la sécurité n'a révélé aucun effet indésirable des médicaments chez les patients atteints de la COVID-19 après le traitement. Ces conclusions ont prouvé que la chloroquine et l'hydroxychloroquine sont efficaces pour le traitement de la COVID-19 chez les adultes hospitalisés. Cela a également confirmé qu' ilssont sûrs. Mots-clés: COVID-19, SARS-CoV-2, essai clinique, innocuité, efficacité, thérapeutiques.

Performance assessment of SD Bioline TB MPT64 assay for the diagnosis of Mycobacterium tuberculosis complex in Lagos, Nigeria.

This study assessed the performance of SD Bioline MPT64 immunochromatographic test for the identification of Mycobacterium tuberculosis complex (MTBC) in Nigeria.A total of 157 mycobacterial isolates, comprising 120 (76.4%) MTBC (M. tuberculosis, 112; M. africanum, 5; M. bovis, 3) and 37 (23.6%) non-tuberculous mycobacteria (NTM) isolates from patients attending six DOTS centers in Lagos between June 2012 and July 2014 were analyzed. All the isolates were grown on Bactec MGIT960 liquid media and identified in parallel by the conventional method and MPT64 immunochromatographic test. Discrepant results were resolved using the line probe assay.The comorbid disease rates for HIV and type 2 diabetes were 20.9% and 8.2%, respectively. Compared to the conventional method, SD Bioline MPT64 identified 117 MTBC isolates correctly, producing a sensitivity of 97.5% (95% CI, 92.9-99.2) at a shorter growing median time of 11 days compared to 26 days by the conventional method. The three undetected MTBC were confirmed by the line probe assay to be M. tuberculosis strains. The test also identified all the NTM correctly producing a specificity of 100% (95% CI, 90.7-100).This study supports the integration of SD Bioline TB MPT64 antigen test into diagnostic workflow for rapid MTBC case identification in Nigeria.

Knowledge and practices of traditional birth attendants in prenatal services in Lagos State, Nigeria.

A questionnaire-based study was conducted on 189 Traditional Birth Attendants (TBAs) on their knowledge and practices in prenatal services. Only 86 (45.5%) of them associated cessation of menstrual period with pregnancy while others use mystic power 46 (24.3%), early morning sickness, pallor of conjunctiva and reaction to herbs 56 (29.6%) to detect pregnancy. Fundal height n=76 (40.2%), palpation n=82 (43.4%), special soaps and soups n=52 (27.5%) and special devices n=8 (4.2%) are used to determine stages of pregnancy. Foetal health status is determined by regular foetal movements n=95 (50.3%), mystic power n=15 (8%), soap n=2 (1.1%), special concoction 9 (4.8%), health status of mother n=67 (35.4%) and foetal heart beat n=24 (12.7%). Ninety seven (51.3%) of them used herbal treatment, 77 (40.7%) used incantations, 189 (100%) used special soaps as their main methods of delivery, while only 18 (9.5%) of respondents refer difficult cases to hospitals. Instruments used for separating cord were blade 123 (65.1%) and scissors 40 (21.1%). Symptoms recognized by the TBAs as signs of complications in pregnancy were dizziness, swollen feet, pallor, tiredness, absent foetal movement, loss of appetite, heaviness, pain in back/stomach/side, weight loss, vomiting, bleeding, fever/malaria, head ache, bad dream, premature or delayed labour. Although some of them recognized some danger signs in pregnancy and labour, only very few would refer difficult cases for emergency obstetric interventions. Clear protocols for management and referral, which are necessary for improved maternal survival, should be provided through regular training of the TBAs.

Serum ferritin and other haematological measurements in apparently healthy children with malaria parasitaemia in Lagos, Nigeria.

One hundred apparently normal nursery and primary school children aged between 2 to 12 years from private schools, in Lagos Nigeria were studied. From this study the mean ferritin levels for children aged 2-5 years, and 6-12 years were 112 +/- 48 micrograms/l, and 119 +/- 38 micrograms/l respectively. Mean haematocrit values were 37.6 +/- 2.2%, and 37.5 +/- 2.6%, while mean haemoglobin levels were 126 +/- 9 g/l 127 +/- 7.9 g/l (2-5 years and 6-12 years respectively). The mean values for MCV, MCH, MCHC were 92 +/- 8.6 fl, 27.6 +/- 3.0 pg, 338.0 +/- 15.0 g/l and 93.5 +/- 9.0 fl, 28.7 +/- 2.5 pg, 332.0 +/- 17.0 g/l (2-5 years and 6-12 years respectively). All haematological parameters measured were similar in both malaria parasitaemia positive and negative subjects, except ferritin level which was significantly higher in subjects with malaria parasitaemia (p < 0.05). There was positive correlation between ferritin concentration and malaria density (r = 0.85, p < 0.05). From the above findings, it would be concluded that, ferritin estimation without examination for malaria parasitaemia in a malarious region like Nigeria is not reliable. It is also concluded that with the high mean ferritin level obtained in this study for normal children on balanced diet, routine iron supplementation may not be necessary for this group of children in Nigeria.