Abstract

Purpose: The objective of this work is to make an observational study of the usage in moderate or severe state COVID-19 patients of a new therapeutic commercial product obtained after immunization of horses: CoviFab^® ELEA F(ab')2 fragmented equine immunoglobulins anti SARS-CoV2.

Methods: Participant centers depend on the Public Health System of Tucumán, Argentina were recruitment. Subjects were assigned to the Moderate Patient Group (MPG) and the Severe Patient Group (SPG), classified according to WHO criteria.

In total, n=84 were enrolled for this study. The subjects were divided into MPG and SPG. All participants were evaluated by physical examination and COVID-19 infection was diagnosed with positive RT-PCR. Each subject received two doses of 0.16 ml/kg, according to the subject's body weight. A generalized linear model with binomial distribution was adjusted for the number of symptoms. Data was analysed using proportion, bivariate and logistic regression. P-value was considered significant at the p<0.05 threshold..

Results: Both groups were similar in age, sex, and comorbidities. A higher proportion of patient with medical discharge was observed in MPG (91.4%) vs. SPG (55.3%) (p=0.004). MPG showed 9 times more chance of receiving medical discharge than SPG (9.33 CI=[1.65, 52.81]; p=0.012). Then, the chance to get medical discharge was independent of variables sex, age, and comorbidities.

Conclusion: Treatment with Equine Serum in patients with moderate and severe disease of COVID-19 managed to slightly reduce hospitalization time. This treatment improved the clinical state to obtain medical discharge. The bivariate analysis showed 8 times more chance in MGP versus SGP to receive of medical discharge and this chance was independent of the pre-existent comorbidities.