A: New clues are hopeful! Alas we can’t yet declare “case closed.”
New data out of Oxford suggest that the inhaled drug budesonide* may greatly reduce hospitalization risk for COVID-19 patients when used within one week of symptom onset. As noted in the press release: “The 28-day study of 146 patients suggested that inhaled budesonide reduced the risk of urgent care or hospitalization by 90% when compared with usual care.” Good news!
BUT…..(and you know there’s always a ‘but’ with us Nerdy Girls!) – we need to pair our optimism with a healthy dose of caution.
Why?! The Trusty 3 C’s can help us out in our trial interpretation: Control, Chance, and Context.
➡Nerdy Girl Rating: STRONG
How credible is the comparison between those who get the treatment and those who don’t? Best protection: randomization. The Oxford study is indeed randomized, the key marker for all of us nerdy trial trackers!
Nerdy Girl Rating: strong on control.
➡Nerdy Girl Rating: MEDIUM
How likely were the results to have arisen from the play of chance? Best protection: large sample sizes. “Randomness doesn’t look random” is a common maxim among researchers, and small samples are particularly vulnerable to data flukes that represent statistical noise as opposed to meaningful signal. While the sample size of 146 patients is not large, the differences between treatment and comparison groups were indeed statistically significant.
Nerdy Girl Rating: medium on chance.
➡Nerdy Girl Rating: WEAK
How well do the results translate beyond the research setting? Best protection: Replication across multiple geographies, time periods, and health care settings. Here’s the big reason that we urge caution in interpreting these results: It is unwise to put too much faith in one individual study, even one that is well-controlled with statistically significant results. Replication is the very best protection we have against overgeneralizing – of note, it is also an important protector against the vagaries of chance.
Nerdy Girl Rating: weak on context.
🙋 OTHER CONSIDERATIONS:
It’s important to note that these results have not yet gone through scientific peer review – an additional caution. It is also worth mentioning that Oxford received funding from both a government funding body and AstraZeneca.
THE BOTTOM LINE:
Stay hopeful, but stay tuned. Like all early-phase trials, it’s best to treat the findings as PROVISIONAL.
Stay Safe. Stay Sane.
Those Nerdy Girls
*Sold as Pulmicourt by AstraZeneca