ELLIS against Covid-19

The BCG CORONA and BCG-CORONA-ELDERLY Clinical Trials

ellis 22 April 2020 - 22 April 2020
22 April 2020 • 13:35 - 13:45

(CWI Amsterdam & Leiden University)

BCG (anti-tuberculosis) vaccin is known to have a "non-specific temporary immune-system boosting" effect. The BCG CORONA randomized clinical trial (approved within 3 days - normally this takes at least 6 months!) tests whether BCG vaccinations reduce sickness (due to corona and otherwise) amongst hospital workers. With standard, p-value based methods, it is neither possible to stop a trial early if preliminary results indicate success or futility (early stopping) nor to keep adding new data if results are promising but nonconclusive (optional continuation) - but this is what we want here. At CWI we have recently been very much involved with safe testing and always-valid confidence intervals, new techniques for hypothesis testing that, unlike earlier approaches (group sequential testing, alpha spending) do allow to stop/continue at every data point. Our methods also provide new ways to combine data from different sources (different hospitals or even different clinical trials - meta-analysis) in an error-proof way. We are helping University Medical Center Utrecht to make their BCG-CORONA trials more flexible in this way.

Video:

Question & Answers

Link to the recording of the live Questions & Discussion session for this talk. 

  • Q: Can you give some details about how you helped in the experimental design of the RCT?

    • A: There are two trials. The second tests efficacy of TBC vaccinations on elderly (over 60). They originally planned to analyze the data simply in a 2x2 table to be made after a certain fixed nr of events (hospitalizations). We convinced the trial statistician to do a time-to-event analysis there with a log rank test or cox regression model. Then they refined that again moving to a Fine-Gray model, because there are "competing risks" (i.e. death instead of hospitalization).

  • Q: Can you give more details on the clinical study? when are results expected? any similar studies ongoing?

    • A: A research group at the University of Melbourne is setting up a BCG study among health care workers using the exact same protocol. Another research group at the University of Exeter will do a similar study in the elderly. And a team at the Max Planck Institute for Infection Biology last week announced that—inspired by Netea’s work—it will embark on a similar trial in elderly people and health workers with VPM1002, a genetically modified version of BCG that has not yet been approved for use against TB. See https://www.sciencemag.org/news/2020/03/can-century-old-tb-vaccine-steel-immune-system-against-new-coronavirus#

Speaker(s):

Thumb ticker peter gru%cc%88nwald
(CWI Amsterdam & Leiden University)