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.BACKGROUND

RBD-specific polyclonal F(ab´)2 fragments
we conducted a double-blind, randomized, placebo-controlled trial to assess efficacy and safety of EpAbs (INM005) in hospitalized adult patients with moderate and severe COVID-19 pneumonia in 19 hospitals of Argentina.  Enrolled patients were assigned to receive two blinded doses of INM005 (n = 118) or placebo (n = 123).  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]). 
INM005
Primary endpoint was improvement in at least two categories in WHO ordinal clinical scale at day 28 or hospital discharge (ClinicalTrials.gov number NCT04494984).



ClinicalTrials.gov
Primary endpoint was improvement in at least two categories in WHO ordinal clinical scale at day 28 or hospital discharge (ClinicalTrials.gov number NCT04494984).



WHO ordinal clinical scale