SARS-CoV-2 specific antibody studies begin

This week, Hydroxychloroquine was brought to the forefront of the drug arena for COVID once again after retraction of a study that reported detrimental effects of the drug (Mehra et al., The Lancet 2020). This study from the Lancet has been called into question after a lack of transparency with data, with the authors (who were not directly involved in the data collection) now questioning the source. This source also had produced a second paper in the New England Journal of Medicine which has also been retracted (Mehra et al., NEJM 2020). Due to these retractions, the World Health Organization has resumed its hydroxychloroquine studies in the SOLIDARITY trial since the discontinuation was based on the erroneously reported detrimental results.

However, it is important to note that to date there has still been no reported benefit of hydroxychloroquine in primary health outcomes, while there have been numerous studies reporting no effects of the drug in COVID-19 (Tang W. et al., 2020; Geleris J. et al., 2020; Borba MGS et al., 2020). These studies reporting no efficacy have been validated and are sufficiently powered.

In exciting news, the first SARS-CoV-2 specific antibody began clinical trials on June 1st. AbCellera first identified 2,000 antibodies that bound to SARS-CoV-2 and manufactured approximately 500 antibodies in their lab. These 500 antibodies were then handed off to drug company, Eli Lilly, which narrowed the 500 to several top candidates. The antibody, LY-CoV500, is currently in trials with phase I results expected by the end of June. Notably, LY-CoV500 has had the fastest track record  to begin clinical trials from the time of antibody identification. If LY-CoV500 does show efficacy in trials, it will be interesting to see how it performs in combination with other therapies such as Remdesivir and potentially Barcitinib, both of which are being tested by the NIH in the ACTT-2 trial.

References

Mehra MR, Desai SS, Ruschitzka F, Patel AN (2020) RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. Lancet. doi:10.1016/S0140-6736(20)31180-6.

Mehra MR, Desai SS, Kuy S, Henry TD, Patel AN (2020) Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. doi:10.1056/NEJMoa2007621.

SOLIDARITY Trial Website: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments

Tang W, et al. (2020) Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial. BMJ369:m1849.

Geleris J, et al. (2020) Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19. N Engl J Med. doi:10.1056/NEJMoa2012410.

Borba MGS, Val FFA, Sampaio VS, et al. Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial. JAMA Netw Open.2020;3(4.23):e208857. doi:10.1001/jamanetworkopen.2020.8857

Eli Lilly LY-CoV500 Announcement: https://investor.lilly.com/news-releases/news-release-details/lilly-begins-worlds-first-study-potential-covid-19-antibody

Eli Lilly and AbCellera Partnership: https://investor.lilly.com/news-releases/news-release-details/abcellera-and-lilly-co-develop-antibody-therapies-treatment


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