Medical Microbiology & Parasitology

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Start date: 2020Subject: search.filters.subject.COVID-19

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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.
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    Malaria and COVID-19 co-infection: a symptom diagnostic challenge in a malaria endemic setting
    (Verduci International, 2021) Fowotade, A.; Bamidele, F. R.; Adekanmbi, O.; Fasina, O. N.; Famuyiwa, O.; Alonge, T. O.
    Objective: To determine the prevalence and risk factors for malaria and COVID-19 co-infection. Patients and methods: A total of 135 COVID-19 positive patients were consecutively recruited from the Infectious Diseases Hospital, Olodo, Ibadan, Oyo State. Nasopharyngeal and oropharyngeal swab samples were obtained during hospitalization and tested by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) using the BGI SARS-Cov-2 kit (China). Blood was also obtained by needle prick and malaria tests were performed using the SD BIOLINE Malaria Ag P.f/Pan test. Risk factors were entered into individual case investigation forms. Results: Malaria and COVID-19 co-infection rate was 7%. The predominant clinical manifestation was fever (28.1%) and the study showed that COVID-19 and malaria co-infection was associated with increased odds of fever compared to COVID-19 mono-infection (p-value=0.415, OR=4.960). Significant risk factors for malaria/COVID-19 are age of participants (p= 0.000) and CT values for by SARS-Cov2 RTPCR (p=0.013). Fever is a common symptom in either malaria or COVID-19 infection thus posing a diagnostic challenge. Proper risk assessment of febrile patients and laboratory evaluation for COVID-19 and/ or malaria is a prerequisite for appropriate distinction.
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    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).
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    Serological profile of convalescent COVID-19 patients at an infectious diseases hospital in Nigeria
    (Sciencedomain International, 2021) Fowotade, A.; Fasuyi, T. O.; Omoruyi,E. C.; Alonge, T. O.
    Background: IgG antibodies may serve as promising targets to detect and evaluate immune responses against the SARS-CoV-2 virus. Both IgA and IgM antibodies target the spike protein’s receptor binding domain and are rapidly decayed, while IgG antibodies remain relatively stable for longer periods in COVID-19 patients. Objectives: The current study was designed to detect the presence of SARS-CoV-2 antibodies among convalescent COVID-19 patients and to evaluate the relationship between these antibodies, the symptom grade and their baseline Cycle Threshold (CT) by RT-PCR. Methods: Eighty-nine convalescent COVID-19 patients on admission were recruited and tested until negative by RT-PCR. Sera obtained from participants were screened for SARS-CoV-2 IgM and IgG antibodies using rapid lateral flow assays. Results: It was observed that 93,3% and 77,5% respectively had IgM and IgG antibodies against the S1 protein of SARS-CoV-2. Majority (74,0%) presented with mild COVID-19 symptoms with a mean RT-PCR Ct value of 31,4. Conclusion: Convalescent COVID-19 patients develop a fairly good level of IgG antibodies. Theantibody status is not dependent on CT value or symptom grade. However, there was a significant correlation between baseline CT and time taken to test negative by RT-PCR.
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    Association of the ABO blood group with SARS-CoV-2 infection in a community with low infection rate
    (International Society of Blood Transfusion, 2021) Kotila, T. R.; Alonge, T. O.; Fowotade, A.; Famuyiwa, O. I.; Akinbile, A. S.
    Background and objectives Reports on the association of the ABO phenotypes with infection by the SARS-CoV-2 virus have mostly come from countries with high infection rates. This study examined the possible association between SARS-CoV-2 infection and the ABO phenotype in Black Africa. Materials and methods This report is from a single centre where both asymptomatic and symptomatic patients were quarantined. At the time of this report, Oyo State, Nigeria had carried out 15 733 tests of which 3119 were positive for the virus with 1952 recoveries and 37 deaths. The ABO distribution of patients was compared with that of a blood donor population. Results Of the 302 participants, 297 (98%) had their blood group determined, asymptomatic and symptomatic individuals were 123 (40_7%) and 179 (59_3%) respectively. Blood group O was significantly less represented among the patients (P < 0_01) while blood groups B and AB were significantly more represented (P < 0_01, P = 0_03 respectively). Patients with anti-B (groups A and O) were significantly less represented than those without anti-B (B and/or AB): B and AB (P < 0_001), B (P = 0_002), AB (P = 0_01). There was no difference in the blood group distribution of symptomatic and asymptomatic patients (v2 (3, N = 302) = 2_29; P = 0_51), but symptomatic patients with anti-A (groups B and O) were more represented than asymptomatic patients with anti-A (v2 4_89; P = 0_03). Conclusion The higher prevalence of blood group O and more potent beta haemolysins (anti-B antibodies) are likely reasons for the lower infectivity by the SARS-CoV-2 virus and severity of COVID-19 disease in the community.
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    Haemocytometric profile of Nigerian patients with Covid-19
    (Faculty of Basic Mdical Sciences, University of Ibadan, 2021) Arinola, O. G.; Edem V. F.; Rahamon, S. K.; Fowotade, A.; Onifade, A. A.; Adekanmbi, O. B.; Salami, O. I.; Fashina, O. A.; Ishola, O. C.; Akinbola, I. O.; Akinbile, A. S.; Eegunjobi, O. A.; Bello, M. D.; Famuyiwa, O. I.; Olaoti, A. J.; Olaniyan, O. A.; Oke, C. A.; Johnson, O. J.; Fagbemi, S. O.; Alonge, T. O.
    The haemocytometric changes and possible interplay with duration of hospital stay, gender and age in Nigerians with COVID-19 were determined in this study. Routine haemocytometry was evaluated using a standard method and thereafter, neutrophil-lymphocyte ratio (NLR); a marker of inflammation was calculated. Neutrophil percentage, total white blood cell (WBC) count and NLR were significantly higher while lymphocyte percentage was significantly lower in patients with COVID-19 compared with the controls. In females with COVID-19, neutrophil percentage was significantly higher compared with the males. Considering length of hospital stay, monocyte percentage was significantly higher in patients who spent more than 10 days on admission compared with those with 10 or fewer days of admission. At discharge, the proportion of patients with monocyte percentage above the reference range was significantly lower compared with baseline. Also, monocyte percentage in COVID-19 patients had significant positive correlation with days on admission. Alteration in haemocytometry worsens with increasing age as percentages of monocyte and neutrophil, NLR and WBC count were significantly higher while the lymphocyte percentage was significantly lower in patients aged 40 years and above compared with younger patients. Also, age had significant positive correlation with percentages of monocyte and neutrophil, NLR and WBC count but a significant negative correlation with lymphocyte percentage. Haemocytometric changes and inflammation in COVID-19 patients increase with age. Also, monocyte count could be an indicator of longer hospital stay and its reduction might be an indicator of recovery from the disease.
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    Qualitative exploration of health system response to COVID-19 pandemic applying the WHO health systems framework: Case study of a Nigerian state
    (Elsevier B.V., 2021) Akinyemi, O.O.; Popoola, O.A.; Fowotade, A.; Adekanmbi O.; Cadmus, E.O.; Adebayo A.
    Pandemics can result in significantly high rates of morbidity and mortality with higher impact in Lower- and Middle-Income Countries like Nigeria. Health systems have an im-portant role in a multi-sector response to pandemics, as there are already concerns that COVID-19 will significantly divert limited health care resources. This study appraised the readiness and resilience of the Nigerian health system to the COVID-19 pandemic, using Oyo State, southwest Nigeria, as a case study. This study was a cross-sectional qualita-tive study involving key informant and in-depth interviews. Purposive sampling was used in recruiting participants who were members of the Task Force on COVID-19 in the state and Emergency Operations Centre (EOC) members (physicians, nurses, laboratory scientists, “contact tracers”, logistic managers) and other partners. The state’s health system response to COVID 19 was assessed using the WHO health systems framework. Audio recordings of the interviews done in English were transcribed and thematic analysis of these tran-scripts was carried out using NVIVO software. Results show that the state government re-sponded promptly by putting in place measures to address the COVID-19 pandemic. How-ever, the response was not adequate owing to the fact that the health system has already been weakened by various challenges like poor funding of the health system, shortage of human resources and inadequate infrastructure. These contributed to the health system’s sub-optimal response to the pandemic. In order to arm the health system for adequate and appropriate response during major health disasters like pandemics, fundamental pillars of the health system-finance, human resources, information and technology, medical equip-ment and leadership - need to be addressed in order to have a resilient health system.