ABSTRACT
Background: Well tolerated antivirals administered early in the course of COVID-19 infection when the viremia is highest could prevent progression to severe disease. Favipiravir inhibits SARS-CoV-2 viral replication in vitro with evidence of clinical benefit in open label trials. Placebo controlled studies of people with early symptomatic COVID-19 with regular assessments of SARS-CoV-2 viral load can determine if it has an antiviral effect and improves clinical outcomes. Methods: People with PCR-confirmed COVID-19 and 5 days or less of symptoms were randomised 1:1 to favipiravir 1800 mg on day 1, then 800 mg twice daily or matched placebo for 14 days. SARS-CoV-2 viral load was quantitated from second daily self-collected nose-throat swabs while receiving study drug. The primary endpoint was time to virological cure defined as 2 successive swabs negative for SARS-CoV-2 by PCR and secondary outcomes were progression of disease severity, symptom resolution and safety. Findings: Between 31 July 2020 and 19 September 2021, 200 people were enrolled (199 in the community, 1 in hospital) with 190 receiving one or more doses of drug (modified intention to treat [mITT] population). There was no difference in time to virological cure (Log-rank p=0.6 comparing Kaplan Meier curves), progression to hospitalisation (14 favipiravir, 9 placebo; p=0.38), time to symptom resolution (cough, fever, sore throat) and there were no deaths. 51 people related an adverse event that was possibly drug related, but these were evenly distributed (n=24 favipiravir, n=27 placebo). Sensitivity analyses where the definition of virological cure was changed to: a single negative PCR, exclude datapoints based on the presence or absence of human DNA in the swab, a SARS-CoV-2 viral load < 300 copies/mL being considered negative all demonstrated no difference between arms. Interpretation: Favipiravir does not improve the time to virological cure or clinical outcomes and shows no evidence of an antiviral effect when treating early symptomatic COVID-19 infection. Funding: The study was supported in part by grants from the Commonwealth Bank Australia, the Lord Mayor's Charitable Foundation, Melbourne Australia and the Orloff Family Charitable Trust, Melbourne, Australia. JHM is supported by the Medical Research Future Fund, AYP, JT are supported by the Australian National Health and Medical Research Council.
ABSTRACT
Covid-19 has continued to affect book reviewing this year, as reviewers whom we had to remind wrote us back saying everything from "I'm stuck in Dakar" or "I crushed my right index finger in an anchor mishap two months ago [and] ... typing was problematic for a number of weeks" to "in the midst of the pandemic I fell and broke my leg in two places," not to mention people's frequent child-care/remote learning challenges (for some books, we had to identify and ask as many as nine potential reviewers before one agreed) or the difficulties of getting books from publishers to reviewers in pandemic-bombed Brazil. Rowman & Littlefield Publishers, 2020, cloth US$ 79.00) Celia Sánchez Manduley: The Life andLegacy of a Cuban Revolutionary, by Tiffany A. Sippial (Chapel Hill: University of North Carolina Press, 2020, paper US$29.95) Staging Discomfort: Performance and Queerness in Contemporary Cuba, by Bretton White (Gainesville: University Press of Florida, 2020, cloth US$ 85.00) The World That Fear Made: Slave Revolts and Conspiracy Scares in Early America, by Jason T. Sharples (Philadelphia: University of Pennsylvania Press, 2020, cloth US$ 45.00) Afrocubanas: History, Thought, and Cultural Practices, edited by Devyn Spence Benson & Daisy Rubiera Castillo (Lanham MD: Monster in the Middle (New York: Riverhead Books [Penguin/Random House], 2021, cloth US$27.00), is the second novel by Virgin Islands-born Tiphanie Yanique-in "Bookshelf 2014," we called her first one, the multiple prize-winning Land of Love and Drowning, "a gem," and this one is as well. In the fictional town of Pleasantview, we meet Syrian shopkeepers, Muslimeen converts, Pentecostal churchgoers, street gang members, Hindus with roadside fruit and vegetable stands, sex workers trafficked from Venezuela and Colombia, lawyers, politicians, and police, as well as myriads of Black women, but the focus, always, is on family relations-misogyny, poverty, violence, and the allure and perils of migration (to New York, Barbados ...)