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Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso
Bu çalışma, Batı Kenya ve Burkina Faso'da sıtmanın (malaria) COVID-19 için bir risk faktörü olup olmadığını araştırmış ve sıtma tedavisinde Artemether-lumefantrine ile Pyronaridine-artesunate ilaçlarını incelemiştir. Çalışmaya, SARS-CoV-2 enfeksiyonu doğrulanmış ve komplikasyonsuz sıtması olan, 6 ay ve üzeri kişiler katılabilmiştir. Çalışma Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Laboratory confirmed SARS-CoV-2 infection, with positive molecular test results within the past 72 hours\* * Aged \>=6 months \*\* * Resident in the study area * The participant or caretaker is willing and able to give informed consent or assent with parent/guardian informed consent for participation in the study * Agrees not to self-medicate with chloroquine, hydroxychloroquine or other antimalarials with potential anti-SARS-CoV-2 properties * Not previously diagnosed with COVID-19 * Contactable by phone for follow-up permitting real-time, reliable information * Uncomplicated malaria, defined as able to take oral medication * Bodyweight ≥5kg * Confirmed malaria infection by RDT (pLDH) or microscopy Exclusion Criteria: * Unwilling or unable to provide informed consent/assent * The participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results * Inability/unlikely to be in the study area for the duration of the 28-day follow-up period * Pregnant or lactating women * Severe disease requiring parenteral treatment * Currently receiving, or recently received (within the last 28 days) pyronaridine-artesunate or artemether-lumefantrine * Received chloroquine in the last three days * Inability/unlikely to be in the study area for the duration of the 42-day follow-up period * Known hypersensitivity or specific contraindication to the use of any of the study drugs in the treatment arms * Known chronic kidney disease (signs or symptoms of stage IV renal impairment or receiving dialysis) * Known liver cirrhosis (Child-Pugh Class B or greater) or signs or symptoms of severe hepatotoxicity