At present, no cure is available for COVID-19 but vaccines, antiviral drugs, immunoglobulins, or the combination of immunoglobulins with antiviral drugs have been suggested and are in clinical trials. The purpose of this paper is to discuss the role of a pharmacokinetic and viral load analysis as a basis for adjusting immunoglobulin dosing to treat COVID-19. We reviewed the pre-clinical and clinical literature that describes the impact of a high antigen load on pharmacokinetic data following antibody treatment. Representative examples are provided to illustrate the effect of high viral and tumor loads on antibody clearance. We then highlight the implications of these factors for facilitating the development and dosing of hyperimmune anti-SARS CoV2 immunoglobulin. Both nonclinical and clinical examples indicate that high antigen loads, whether they be viral, bacterial, or tumoral in origin, result in increased clearance and decreased area under the curve and half-life of antibodies. A dosing strategy that matches the antigen load can be achieved by giving initially high doses and adjusting the frequency of dosing intervals based on pharmacokinetic parameters. We suggest that study design and dose selection for immunoglobulin products for the treatment of COVID-19 require special considerations such as viral load, antibody-virus interaction, and dosing adjustment based on the pharmacokinetics of the antibody.

目前，尚无治愈COVID-19的方法，但已提出疫苗，抗病毒药物，免疫球蛋白或免疫球蛋白与抗病毒药物的组合，并且正在临床试验中。本文的目的是讨论药代动力学和病毒载量分析的作用，作为调整免疫球蛋白剂量以治疗COVID-19的基础。我们回顾了描述抗体治疗后高抗原负荷对药代动力学数据影响的临床前和临床文献。提供了代表性的例子来说明高病毒和肿瘤载量对抗体清除的影响。然后，我们强调了这些因素对促进超免疫抗SARS CoV2免疫球蛋白的开发和给药的影响。非临床和临床实例均表明高抗原负荷，无论它们是病毒，细菌或肿瘤起源，都会导致清除率增加，抗体曲线下面积和半衰期减少。可以通过最初给予高剂量并根据药代动力学参数调整给药间隔的频率来实现与抗原载量匹配的给药策略。我们建议用于治疗COVID-19的免疫球蛋白产品的研究设计和剂量选择需要特殊考虑，例如病毒载量，抗体与病毒的相互作用以及基于抗体药代动力学的剂量调整。可以通过最初给予高剂量并根据药代动力学参数调整给药间隔的频率来实现与抗原载量匹配的给药策略。我们建议用于治疗COVID-19的免疫球蛋白产品的研究设计和剂量选择需要特殊考虑，例如病毒载量，抗体与病毒的相互作用以及基于抗体药代动力学的剂量调整。可以通过最初给予高剂量并根据药代动力学参数调整给药间隔的频率来实现与抗原载量匹配的给药策略。我们建议用于治疗COVID-19的免疫球蛋白产品的研究设计和剂量选择需要特殊考虑，例如病毒载量，抗体与病毒的相互作用以及基于抗体药代动力学的剂量调整。