RBD-specific polyclonal F(ab )2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial

https://doi.org/10.1016/j.eclinm.2021.100843

NCT04494984-Enrolled patients were assigned to receive two blinded doses of INM005 (n = 118) or placebo (n = 123). Median age was 54 years old, 65*1% were male and 61% had moderate disease at baseline. Median time from symptoms onset to study treatment was 6 days (interquartile range 5 to 8). No statistically significant difference was noted between study groups on primary endpoint (risk difference [95% IC]: 5*28% [-3*95; 14*50]; p = 0*15). Rate of improvement in at least two categories was statistically significantly higher for INM005 at days 14 and 21 of follow-up. Time to improvement in two ordinal categories or hospital discharge was 14*2 (+/- 0*7) days in the INM005 group and 16*3 (+/- 0*7) days in the placebo group, hazard ratio 1*31 (95% CI 1*0 to 1*74). Subgroup analyses showed a beneficial effect of INM005 over severe patients and in those with negative baseline antibodies. Overall mortality was 6*9% the INM005 group and 11*4% in the placebo group (risk difference [95% IC]: 0*57 [0*24 to 1*37]). Adverse events of special interest were mild or moderate; no anaphylaxis was reported. Albeit not having reached the primary endpoint, we found clinical improvement of hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease.

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