Solidarity PLUS Trial for COVID-19 Treatments - New Jersey Anesthesia Professionals
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Solidarity PLUS Trial for COVID-19 Treatments

With global COVID-19 cases surpassing 200 million in August and many expecting cases to reach 300 million early next year, the need for effective medications for infected patients has never been greater [1, 2]. In August 2021, the World Health Organization (WHO) announced the second leg of the Solidarity trial to test candidate treatments for COVID-19, Solidarity PLUS [3]. The initiative will test the efficacy of three preexisting medications on COVID-19 patients: artesunate, imatinib, and infliximab [3]. Solidarity PLUS will be carried out in 600 hospitals across 52 countries, making it significantly larger than the initial trial [3]. The expectation is that, by conducting such a large-scale trial, researchers will quickly verify whether these drugs can improve the treatment of COVID-19 patients effectively [1].

Solidarity PLUS will be a double-blind, randomized experimental design [4]. The primary outcome is “in-hospital, all-cause mortality,” while the second outcomes are the “need for ventilation and duration of hospital stay in the overall population, as well as in low-risk and high-risk patient groups” [4]. To be a subject, patients must be hospitalized due to lab-confirmed COVID-19 infection and be more than 18 years old [4]. In contrast to the original Solidarity trial, new medications can be added to the trial and ineffectual ones removed based on observed results [3]. 

Despite their highly varying uses and mechanisms, experts chose the three central medications for their noted anti-inflammatory properties [5]. Artesunate has treated malaria and other parasitic diseases for more than thirty years [3]. During the trial, patients in the artesunate group will receive it intravenously each day for seven days, with the dose corresponding to that given to sufferers of severe malaria [3]. 

Conversely, imatinib is a small molecule tyrosine kinase inhibitor, typically prescribed as oral chemotherapy against gastrointestinal stromal tumors and chronic myeloid leukemia [3, 4]. Subjects will receive imatinib orally, once a day for fourteen days [3]. Imatinib seems promising for COVID-19 patients due to a Dutch study that found it to reduce mortality, potentially owing to its anti-inflammatory effects [4]. Furthermore, imatinib might also be capable of restoring damaged lungs, making it a promising candidate in the search for successful medications [6].

Lastly, infliximab is an autoimmune medication with twenty years of proven success in countering rheumatoid arthritis and Crohn’s Disease [3]. It is especially notable for its safety in the elderly, which, if applicable to the context of COVID-19 patients, would make it a prime option for certain high-risk patients [3]. A German trial conducted in 2020 suggested that infliximab reduced the chance that patients would suffer the complication-inducing cytokine storm associated with COVID-19 [4]. If these results are confirmed by the Solidarity PLUS trial, global survival rates among the infected could increase significantly.

Owing to the cooperative nature of the Solidarity PLUS trial, we can expect results in September 2021 [1]. Even if none of the three medications prove to be effective counters to the progression of COVID-19, that information will help guide clinical decision making as healthcare providers explore treatment options.

References 

[1] UN, “WHO announces three new drugs for latest COVID-19 ‘Solidarity’ trials,” United Nations, Updated August 11, 2021. [Online]. Available: https://news.un.org/en/story/2021/08/1097542

[2] M. Shields and D. Nadeem, “WHO-led trial to study three anti-inflammatory drugs for COVID-19 patients,” Reuters, Updated August 11, 2021. [Online]. Available: https://www.reuters.com/world/india/who-led-trial-study-three-anti-inflammatory-drugs-covid-19-patients-2021-08-11/

[3] WHO, “Solidarity PLUS trial for promising drugs will roll out in 52 countries, an unprecedented global collaboration for COVID-19 R&D,” World Health Organization, Updated August 11, 2021. [Online]. Available: https://www.who.int/news/item/11-08-2021-who-s-solidarity-clinical-trial-enters-a-new-phase-with-three-new-candidate-drugs

[4] M. Sullivan, “Seeking New COVID-19 Therapeutics, WHO Expands its Solidarity Study to Include Three Licensed Drugs,” WCG FDA News, Updated August 12, 2021. [Online]. Available: https://www.fdanews.com/articles/203953-seeking-new-covid-19-therapeutics-who-expands-its-solidarity-study-to-include-three-licensed-drugs. 

[5] R. Haridy, “WHO begins global trial testing trio of drugs to treat severe COVID-19,” New Atlas, Updated August 11, 2021. [Online]. Available: https://newatlas.com/health-wellbeing/who-solidarity-plus-coronavirus-infliximab-artesunate-imatinib/. 

[6] E. Anthes, “The World Health Organization is testing three more drugs in a broad search for Covid treatments,” The New York Times, Updated August 11, 2021. [Online]. Available: https://www.nytimes.com/2021/08/11/health/world-health-organization-drugs-virus.html