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1.
Journal of the American Heart Association ; : e026143, 2022.
Article in English | MEDLINE | ID: covidwho-2001999

ABSTRACT

Background Published randomized controlled trials are underpowered for binary clinical end points to assess the safety and efficacy of renin-angiotensin system inhibitors (RASi) in adults with COVID-19. We therefore performed a meta-analysis to assess the safety and efficacy of RASi in adults with COVID-19. Methods and Results MEDLINE, EMBASE, ClinicalTrials.gov, and the Cochrane Controlled Trial Register were searched for randomized controlled trials that randomly assigned patients with COVID-19 to RASi continuation/commencement versus no RASi therapy. The primary outcome was all-cause mortality at <=30 days. A total of 14 randomized controlled trials met the inclusion criteria and enrolled 1838 participants (aged 59 years, 58% men, mean follow-up 26 days). Of the trials, 11 contributed data. We found no effect of RASi versus control on all-cause mortality (7.2% versus 7.5%;relative risk [RR], 0.95;[95% CI, 0.69-1.30]) either overall or in subgroups defined by COVID-19 severity or trial type. Network meta-analysis identified no difference between angiotensin-converting enzyme inhibitors versus angiotensin II receptor blockers. RASi users had a nonsignificant reduction in acute myocardial infarction (2.1% versus 3.6%;RR, 0.59;[95% CI, 0.33-1.06]), but increased risk of acute kidney injury (7.0% versus 3.6%;RR, 1.82;[95% CI, 1.05-3.16]), in trials that initiated and continued RASi. There was no increase in need for dialysis or differences in congestive cardiac failure, cerebrovascular events, venous thromboembolism, hospitalization, intensive care admission, inotropes, or mechanical ventilation. Conclusions This meta-analysis of randomized controlled trials evaluating angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers versus control in patients with COVID-19 found no difference in all-cause mortality, a borderline decrease in myocardial infarction, and an increased risk of acute kidney injury with RASi. Our findings provide strong evidence that RASi can be used safely in patients with COVID-19.

2.
BMJ Global Health ; 7:A14-A15, 2022.
Article in English | EMBASE | ID: covidwho-1968261

ABSTRACT

Background The recent Covid-19 pandemic has accelerated the use of LSRs and PMAs, viewed as the 'next generation systematic reviews and meta-analyses'. LSRs and PMAs are prospective designs that can reduce the problems of traditional retrospective meta-analyses (MA) such as selective outcome reporting and publication bias, missing data, etc., and thus offer a better option for incorporating and generating new evidence. Objectives We propose the Bayesian approach as a method for analysing LSRs and PMAs. Bayesian Meta Analysis (BMA) is particularly appealing - actually, natural - for these designs as it clearly reflects the process of learning, defined as new evidence coming to update the previous knowledge, that is intrinsic to LSRs and PMAs. Methods Results pooled in the previous update of the LSR, or derived from the studies already known in the PMA, can be used to provide an objective/historical prior distribution. The combination of this information with the accumulated results (conditioning on these) provides the posterior probability distribution that can be used as the prior in the next iteration of the LSR/PMA (yesterday's posterior becomes tomorrow's prior). Results We will show an example of BMA on a LSR of the association between Covid-19 and asthmatic patients and give practical suggestions for its use. Discussion Without relying on asymptomatic normality assumptions, BMA is suitable as it is a coherent and flexible framework that, in comparison with frequentist MAs, allows a better assessment of the between-study variance and overcomes some common issues as dealing with missing data and publication bias.

3.
South African Medical Journal ; 112(2 b), 2022.
Article in English | EMBASE | ID: covidwho-1706330

ABSTRACT

Sisonke is a multicentre, open-label, single-arm phase 3B vaccine implementation study of healthcare workers (HCWs) in South Africa, with prospective surveillance for 2 years. The primary endpoint is the rate of severe COVID-19, including hospitalisations and deaths. The Sisonke study enrolled and vaccinated participants nationally at potential vaccination roll-out sites between 17 February and 26 May 2021. After May 2021, additional HCWs were vaccinated as part of a sub-study at selected clinical research sites. We discuss 10 lessons learnt to strengthen national and global vaccination strategies: (i) consistently advocate for vaccination to reduce public hesitancy;(ii) an electronic vaccination data system (EVDS) is critical;(iii) facilitate access to a choice of vaccination sites, such as religious and community centres, schools, shopping malls and drive-through centres;(iv) let digitally literate people help elderly and marginalised people to register for vaccination;(v) develop clear 'how to' guides for vaccine storage, pharmacy staff and vaccinators;(vi) leverage instant messaging platforms, such as WhatsApp, for quick communication among staff at vaccination centres;(vii) safety is paramount - rapid health assessments are needed at vaccination centres to identify people at high risk of serious adverse events, including anaphylaxis or thrombosis with thrombocytopenia syndrome. Be transparent about adverse events and contextualise vaccination benefits, while acknowledging the small risks;(viii) provide real-time, responsive support to vaccinees post vaccination and implement an accessible national vaccine adverse events surveillance system;(ix) develop efficient systems to monitor and investigate COVID-19 breakthrough infections;and (x) flexibility and teamwork are essential in vaccination centres across national, provincial and district levels and between public and private sectors.

4.
S Afr Med J ; 112(2b): 13486, 2021 12 24.
Article in English | MEDLINE | ID: covidwho-1678836

ABSTRACT

Sisonke is a multicentre, open-label, single-arm phase 3B vaccine implementation study of healthcare workers (HCWs) in South Africa, with prospective surveillance for 2 years. The primary endpoint is the rate of severe COVID­19, including hospitalisations and deaths. The  Sisonke study enrolled and vaccinated participants nationally at potential vaccination roll-out sites between 17 February and 26 May 2021. After May 2021, additional HCWs were vaccinated as part of a sub-study at selected clinical research sites. We discuss 10 lessons learnt to strengthen national and global vaccination strategies:(i) consistently advocate for vaccination to reduce public hesitancy; (ii) an electronic vaccination data system (EVDS) is critical; (iii) facilitate access to a choice of vaccination sites, such as religious and community centres, schools, shopping malls and drive-through centres; (iv) let digitally literate people help elderly and marginalised people to register for vaccination; (v) develop clear 'how to' guides for vaccine storage, pharmacy staff and vaccinators; (vi) leverage instant messaging platforms, such as WhatsApp, for quick communication among staff at vaccination centres; (vii) safety is paramount - rapid health assessments are needed at vaccination centres to identify people at high risk of serious adverse events, including anaphylaxis or thrombosis with thrombocytopenia syndrome. Be transparent about adverse events and contextualise vaccination benefits, while acknowledging the small risks; (viii) provide real-time, responsive support to vaccinees post vaccination and implement an accessible national vaccine adverse events surveillance system; (ix) develop efficient systems to monitor and investigate COVID­19 breakthrough infections; and (x) flexibility and teamwork are essential in vaccination centres across national, provincial and district levels and between public and private sectors.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Health Personnel , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Mass Vaccination , Humans , Prospective Studies , SARS-CoV-2 , South Africa/epidemiology
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