Olagunju, Adeniyi;Fowotade, Adeola;Olagunoye, Ajibola;Ojo, Temitope Olumuyiwa;Adefuye, Bolanle Olufunlola;Fagbamigbe, Adeniyi Francis;Adebiyi, Akindele Olupelumi;Olagunju, Omobolanle Ibitayo;Ladipo, Olabode Taiwo;Akinloye, Abdulafeez;Adeagbo, Babatunde Ayodeji;Onayade, Adedeji;Bolaji, Oluseye Oladotun;Happi, Christian;Rannard, Steve;Owen, Andrew published 《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》. The research results were published in《Trials》 in 2021.Recommanded Product: 55981-09-4 The article conveys some information:
To investigate the efficacy and safety of repurposed antiprotozoal and antiretroviral drugs, nitazoxanide and atazanavir/ritonavir, in shortening the time to clin. improvement and achievement of SARS-CoV-2 polymerase chain reaction (PCR) negativity in patients diagnosed with moderate to severe COVID-19. This is a pilot phase 2, multicentre 2-arm (1:1 ratio) open-label randomised controlled trial. Patients with confirmed COVID-19 diagnosis (defined as SARS-CoV-2 PCR pos. nasopharyngeal swab) will be recruited from four participating isolation and treatment centers 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. 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 h 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 mech. ventilation at screening. 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 center in line with the current guidelines for clin. management of COVID-19 in Nigeria. Main outcome measures are: (1) Time to clin. 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 Clin. Characterization 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) neg. 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 vs. 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. None, this is an open-label trial. 98 Patients (49 per arm). Regulatory approval was issued by the National Agency for Food and Drug Administration and Control on 06 Oct. 2020 (protocol version number is 2.1 dated 06 August 2020). Recruitment started on 9 Oct. 2020 and is anticipated to end before Apr. 2021. And 2-((5-Nitrothiazol-2-yl)carbamoyl)phenyl acetate (cas: 55981-09-4) was used in the research process.
2-((5-Nitrothiazol-2-yl)carbamoyl)phenyl acetate(cas: 55981-09-4), a thiazolide compound, is a antiparasitic drug with structure similar to niclosamide.Recommanded Product: 55981-09-4
Reference:
Thiazole | C3H3NS – PubChem,
Thiazole | chemical compound | Britannica