Weekly Insights from the COVID-19 Trial Tracker

April 23, 2020

Every Week Cytel Brings You Further Insights from the COVID-19 Trial Tracker

From April 8 through April 17, the number of clinical trials testing COVID-19 therapies has risen to 590 world-wide. An estimated 354,000 people will need to be recruited to test these treatments properly, representing a substantial proportion of all patients diagnosed with COVID-19. Last week we looked at recruitment for chloroquine and hydroxychloroquine. This week we take a look at studies for lopinavir, remdesivir, and plasma based therapy.

Lopinavir

Lopinavir is normally used to treat HIV patients, and has recently become a popular subject of investigation for those looking for a COVID-19 therapy. Currently 6 trials have completed for lopinavir and an additional 31 are recruiting.

The largest of these are a multi-country study conducted by WHO which is currently recruiting 130,000 patients. Preliminary evidence to date from two randomized trials with published results has not indicated a benefit for severe hospitalized patients [1], or for those with mild/moderate disease [2].

Remdesivir

Remdesivir was originally developed as an anti-viral response to the Ebola and Marbug virus outbreaks. There are currently 10 studies actively recruiting for remdesivir, including 6 large multi- country trials. The two largest are open-label trials spearheaded by Gilead, a dose-finding trial and one comparing remdesivir to standard of care. For severe patients, 6,000 individuals will be grouped depending on the presence or absence of mechanical ventilation and treated with remdesivir. For mild/moderate patients, remdesivir will be provided for either 5 or 10 days treatment.

Other trials containing remdesivir have been launched by the National Institute of Allergies and Infectious Diseases (NIAID), as well as by the World Health Organization (SOLIDARITY trial). Press releases indicate that preliminary evidence will be published on Remdesivir over the coming weeks.

Plasma Based Therapy

Currently 27 trials for plasma based therapies have identified, of which 14 are actively recruiting. Geared towards some of the most severely ill patients, these trials are aiming to recruit approximately 3,530 patients. The largest of the actively recruiting trials is a single blind, randomized study being undertaken by researchers at Erasmus University in the Netherlands, with results due early January.

References:

[1] https://www.nejm.org/doi/pdf/10.1056/NEJMoa2001282?articleTools=true

[2] https://marlin-prod.literatumonline.com/pb-assets/products/coronavirus/MEDJ1.pdf