Serum-derived bovine immunoglobulin treatment in COVID-19 is associated with faster resolution of symptoms: A randomized pilot clinical trial

Abstract

Effective treatment to prevent hospitalization and death in people with COVID-19 exists, but people still need interventions that alleviate symptoms without drug interactions. Oral serum-derived bovine immunoglobulins (SBI) may reduce symptoms and time-to-improvement in people with mild-to-moderate COVID-19. In this randomized, open-label, single-site study, participants with mild-to-moderate COVID-19 received SBI 5.0 g bis in die (BID) + Standard of Care (SOC) or SOC alone (2:1) for 2 weeks. After 2 weeks, 78.8% of hospitalized participants on SBI + SOC improved by World Health Organization (WHO) scale of ≥3 compared to 61.1% on SOC alone (odds ratio: OR = 2.4; p = 0.0663), with older participants (>57 years) showing more significant differences between the arms (OR = 6.1; p = 0.0109). Further, more participants on SBI + SOC reported absence of COVID-19 symptoms at Week 2 (74.2%) compared to SOC alone (43.6%; OR = 3.7; p = 0.0031), most notably the absence of dyspnea on exertion (OR = 4.4; p = 0.0047), with women exhibiting the most significant eradication of all symptoms (OR = 5.8; p = 0.0080). No difference in change of IL-6 between arms was observed. Overall, participants with mild-to-moderate COVID-19 on SBI + SOC had a shorter time-to-recovery than on SOC alone, with a significantly higher rate of complete resolution of symptoms. Dyspnea on exertion was the symptom most significantly impacted. For people with mild-to-moderate COVID-19, oral SBI could be a safe and effective intervention, devoid of drug interactions.

Keywords: COVID‐19; disease management; medical food product; serum‐derived bovine immunoglobulin.