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.

Prevalence and Clinical Characteristics of Coronavirus Disease 2019 Seen at a Testing Centre in Lagos Nigeria.

BACKGROUND: The SARS-CoV-2 infection continues to ravage the global community since it was declared a pandemic. The socio-demographic and clinical characteristics defining the disease are mainly from Europe and Asia. The disease symptomatology is similar to the prevalent diseases in our environment, this could result in the delay in prompt identification and appropriate management of suspected cases toward combating community transmission. This study evaluates the prevalence, socio-demographic and clinical characteristics of positive cases of COVID -19. METHODS: This was a retrospective cohort study. Data on the socio-demographic, clinical characteristics and the results of the SARS-CoV-2 test of participants at the Nigerian Institute of Medical Research [NIMR] Modified Drive-through Centre for COVID-19 test sample collection over two months [24th February 2020- 27th April 2020] were retrieved from the electronic medical records (EMR). Data obtained were analyzed using SPSS version 22.0. RESULTS: A total number of 481 clients were evaluated in this review. The prevalence of SARS-CoV-2 infection in the population was 14.6%. The mean age of the positive cases was 42.2 [±15.9] years. The common symptoms reported by the positive cases were fever (40.0%), cough (32.9%), sore throat (17.1%) and running nose (15.7%). Fever depicted statistical significance with positive cases with the majority being of mild to moderate clinical severity. CONCLUSION: The prevalence of SARS-CoV-2 infection among this cohort was 14.6% with a male preponderance. Fever and sore throat were the variables that predicted SARS CoV-2 infection among our cohort.

Immunological and virological response to haart in HIV-1 patients co-infected with hepatitis B and C viruses.

BACKGROUND: Among the countries highly endemic for viral hepatitis, Nigeria is found. Information on how triple infected persons (HIV, HBV, and HCV) fare on HAART in the country is lacking. Laboratory based investigation was carried out to assess the virological and immunological parameters of HIV-1 infected patients co-infected with Hepatitis B and C, accessing care at the Nigerian Institute of Medical Research. It was a case controlled study. OBJECTIVES: The study aimed to compare the laboratory data of HIV-HBV-HCV patients seen between 2006 and 2009 with HIV-1 monoinfected patients in the same period, on HAART according to the national guideline and followed up for 12 months. METHODS: Detection of Hepatitis B surface Antigen (HBsAg) and Hepatitis C Virus Antibody (HCVAb) were assayed using ELISA techniques (Bio Rad and DIA PRO respectively). The CD4 and HIV viral load were determined using the Cyflow Counter/Kits (Partec) and the Amplicor HIV-1 Monitor Test V1.5 (Roche) techniques respectively. RESULTS: Forty-one (0.4%) of the 10,214 HIV-1 patients seen during the period were co-infected with both HBV and HCV. Over the 12 month-period, median HIV-1 viral load and CD4 count reduced and increased respectively (12,205-200 RNA copies/mL; 210-430 cells/mL from baseline - 12th month), and for the HIV-1 monoinfected patients (36,794-200 RNA copies/mL [p=0.5485] and 206-347 cells/mL [p=0.7703] from baseline - 12th month). CONCLUSION: There seems to be no significant influence of hepatitis B and C in HIV infection on HAART judging by the CD4 and viral load profiles which were similar in the two groups.