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 ( = 26) and SoC plus intervention arms ( = 31; Cox proportional hazards regression analysis adjusted hazard ratio, aHR = 0.898, 95% CI: 0.492-1.638, = 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, = 0.919). There was no significant difference in time to complete symptom resolution (aHR = 0.535, 95% CI: 0.251-1.140, = 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 EC 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.
Clinical Trial Registration: [https://clinicaltrials.gov/ct2/show/NCT04459286], identifier [NCT04459286].
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http://dx.doi.org/10.3389/fmed.2022.956123 | DOI Listing |
Eur J Med Res
December 2024
Bloomsbury Institute of Intensive Care Medicine, Division of Medicine, University College London, London, UK.
Background: Dexamethasone 6 mg in patients with severe COVID-19 has been shown to decrease mortality and morbidity. The effects of higher doses of corticosteroid, that would further increase anti-inflammatory effects, are uncertain. The objective of our study was to assess the effect of 20 mg dexamethasone vs.
View Article and Find Full Text PDFBackground: Recurrent gynecological clear cell carcinoma (rGCCC) has a low objective response rate (ORR) to chemotherapy. Previous preclinical and clinical data suggest a potential synergy between immune checkpoint inhibitors and bevacizumab in rGCCC. Dostarlimab, a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1), combined with the anti-angiogenic bevacizumab, presents a novel therapeutic approach.
View Article and Find Full Text PDFJ Pediatr (Rio J)
December 2024
Faculdade de Medicina da Universidade de São Paulo (FMUSP), Instituto da Criança, Unidade de Endocrinologia Pediátrica, São Paulo, São Paulo, Brazil.
Objective: Discontinuation of growth hormone therapy (rhGH) upon completion of linear growth may adversely affect bone mineral density and content (BMD/BMC) in adolescents with childhood-onset GH deficiency (CO-GHD) and predisposition to osteoporosis. Although the benefits of weight-dependent somatropin high doses over bone gain are established, little is known about fixed low doses. We analyzed the impact of non-weight-based low-dose somatropin on bone accrual during the transition among CO-DGH patients, treated since childhood.
View Article and Find Full Text PDFLancet Microbe
December 2024
Jiangxi Provincial Key Laboratory of Digestive Diseases, Department of Gastroenterology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China. Electronic address:
Background: Vonoprazan and amoxicillin (VA) dual therapy as a mainstream Helicobacter pylori regimen has gained momentum worldwide, but the optimum dosages remain unclear. We aimed to compare the efficacy and safety of VA dual therapy with 2 g amoxicillin or 3 g amoxicillin, and to assess the short-term effects of therapy on the gut microbiota and antibiotic resistome.
Methods: We conducted an open-label, non-inferiority randomised controlled trial at 12 centres in China.
Lancet Infect Dis
December 2024
MMV Medicines for Malaria Venture, Geneva, Switzerland.
Background: Novel antimalarials are needed to address emerging resistance to artemisinin and partner drugs. We did two trials to evaluate safety, tolerability, pharmacokinetics, and activity against blood stage Plasmodium falciparum for the drug candidate MMV533.
Methods: A phase 1a first-in-human (FIH) trial was conducted at Nucleus Network (Melbourne, VIC, Australia).
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