Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

[Jm954]

This is a non reviewed preprint

REGEN-COV is a combination of 2 monoclonal antibodies (casirivimab and imdevimab) that bind to two different sites on the receptor binding domain of the SARS-CoV-2 spike protein. They aimed to evaluate the efficacy and safety of REGEN-COV in patients admitted to hospital with COVID-19.

Between 18 September 2020 and 22 May 2021, 9785 patients were randomly allocated to receive usual care plus REGEN-COV or usual care alone, including 3153 (32%) seronegative patients, 5272 (54%) seropositive patients and 1360 (14%) patients with unknown baseline antibody status.

In the primary efficacy population of seronegative patients, 396 (24%) of 1633 patients allocated to REGEN-COV and 451 (30%) of 1520 patients allocated to usual care died within 28 days (rate ratio 0·80; 95% CI 0·70-0·91; p=0·0010).

In an analysis involving all randomised patients (regardless of baseline antibody status), 944 (20%) of 4839 patients allocated to REGEN-COV and 1026 (21%) of 4946 patients allocated to usual care died within 28 days (rate ratio 0·94; 95% CI 0·86-1·03; p=0·17). The proportional effect of REGEN-COV on mortality differed significantly between seropositive and seronegative patients (p value for heterogeneity = 0·001).

In patients hospitalised with COVID-19, the monoclonal antibody combination of casirivimab and imdevimab (REGEN-COV) reduced 28-day mortality among patients who were seronegative at baseline.

The trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936).

Trial details here: recoverytrial.net

Jackie

[bennevisplace]

Thanks. I'd be interested to hear your take on this Jackie. I've already given mine on an earlier thread: not that impressed.

[Jm954 Administrator in reply to bennevisplace]

Nope, not impressed at all.

[Justasheet1 in reply to Jm954]

Jackie,

I wonder what the numbers would have looked like if given before they needed admission.

Jeff

[Jonquiljo]

Yes, the later you start Mab infusion, the less they can fight a COVID infection. That has been the problem all these months. The ideal scenario is to give the Mab infusion early on while it has a chance to significantly inhibit viral replication and damage. If treating physicians wait until someone is already in need of hospitalization, then the results are far from spectacular.

So, as had been discussed here many times - the best time to get a Mab infusion is early on in the disease course. The longer you wait the less it will do.

Why physicians can't seem to understand this almost intuitive concept is beyond my comprehension. The same thing has been done with most anti-COVID agents - they give them to people once they are hospitalized (like Remdesivir). And then the medical community makes approval of these drugs contingent upon hospitalization. Wrong!

If you want to save lives, you have to think outside of the box!

If they took a thousand of the patients they are talking about in this analysis and treated them with Mab within 1-7 days of a positive test (hopefully obtained rapidly), then they may have seen outstanding numbers instead of what they report here.

Sorry - I'm not impressed with the clinical research design more than I am not impressed with the reported results with Mab treatment.