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1.
EBioMedicine ; 86: 104322, 2022 Nov 01.
Article in English | MEDLINE | ID: covidwho-2095268

ABSTRACT

BACKGROUND: This exploratory study investigated four repurposed anti-infective drug regimens in outpatients with COVID-19. METHODS: This phase 2, single centre, randomised, open-label, clinical trial was conducted in South Africa between 3rd September 2020 and 23rd August 2021. Symptomatic outpatients aged 18-65 years, with RT-PCR confirmed SARS-CoV-2 infection were computer randomised (1:1:1:1:1) to standard-of-care (SOC) with paracetamol, or SOC plus artesunate-amodiaquine (ASAQ), pyronaridine-artesunate (PA), favipiravir plus nitazoxanide (FPV + NTZ), or sofosbuvir-daclatasvir (SOF-DCV). The primary endpoint was the incidence of viral clearance, i.e., the proportion of patients with a negative SARS-CoV-2 RT-PCR on day 7, compared to SOC using a log-binomial model in the modified intention-to-treat (mITT) population. FINDINGS: The mITT population included 186 patients: mean age (SD) 34.9 (10.3) years, body weight 78.2 (17.1) kg. Day 7 SARS-CoV-2 clearance rates (n/N; risk ratio [95% CI]) were: SOC 34.2% (13/38), ASAQ 38.5% (15/39; 0.80 [0.44, 1.47]), PA 30.3% (10/33; 0.69 [0.37, 1.29]), FPV + NTZ 27.0% (10/37; 0.60 [0.31, 1.18]) and SOF-DCV 23.5% (8/34; 0.47 [0.22, 1.00]). Three lower respiratory tract infections occurred (PA 6.1% [2/33]; SOF-DCV 2.9% [1/34]); two required hospitalisation (PA, SOF-DCV). There were no deaths. Adverse events occurred in 55.3% (105/190) of patients, including one serious adverse event (pancytopenia; FPV + NTZ). INTERPRETATION: There was no statistical difference in viral clearance for any regimen compared to SOC. All treatments were well tolerated. FUNDING: Medicines for Malaria Venture, with funding from the UK Foreign, Commonwealth and Development Office, within the Covid-19 Therapeutics Accelerator in partnership with Wellcome, the Bill and Melinda Gates Foundation, and Mastercard.

2.
Am J Speech Lang Pathol ; 30(6): 2456-2464, 2021 11 04.
Article in English | MEDLINE | ID: covidwho-1545675

ABSTRACT

Purpose While research has confirmed the feasibility and validity of delivering clinical swallowing evaluations (CSEs) via telepractice, challenges exist for clinical implementation. Using an implementation framework, strategies that supported implementation of CSE services via telepractice within 18 regional/rural sites across five health services were examined. Method A coordinated implementation strategy involving remote training and support was provided to 18 sites across five health services (five hub and spoke services) that had identified a need to implement CSEs via telepractice. Experiences of all 10 speech-language pathologists involved at the hub sites were examined via interviews 1 year post implementation. Interview content was coded using the Consolidated Framework for Implementation Research (CFIR) and constructs were rated for strength and direction of influence, using published CFIR coding conventions. Results Services were established and are ongoing at all sites. Although there were site-specific differences, 10 CFIR constructs were positive influencing factors at all five sites. The telepractice model was perceived to provide clear advantages for the service, and clinicians were motivated by positive patient response. Strategies used to support implementation, including having a well-organized implementation resource and an external facilitator who worked closely with the local champions, were highly valued. Two CFIR constructs, Structural Characteristics and Available Resources, were challenges for all sites. Conclusions A complex interplay of factors influenced service implementation at each site. A strong local commitment to improving patient care, and the assistance of targeted strategies to support local implementation were viewed as central to enabling implementation.


Subject(s)
Communication Disorders , Deglutition , Delivery of Health Care , Humans
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