A pilot trial of human amniotic fluid for the treatment of COVID-19

Craig H Selzman, Joseph E Tonna, Jan Pierce, Camila Vargas, Chloe Skidmore, Giavonni Lewis, Nathan D Hatton, John D Phillips, Craig H Selzman, Joseph E Tonna, Jan Pierce, Camila Vargas, Chloe Skidmore, Giavonni Lewis, Nathan D Hatton, John D Phillips

Abstract

Objective: Vertical transmission from SARS CoV-2-infected women is uncommon and coronavirus has not been detected in amniotic fluid. Human amniotic products have a broad immune-mediating profile. Observing that many COVID-19 patients have a profound inflammatory response to the virus, we sought to determine the influence of human amniotic fluid (hAF) on hospitalized patients with COVID-19.

Results: A 10-patient case series was IRB-approved to study the impact of hAF on hospitalized patients with documented COVID-19. Nine of the 10 patients survived to discharge, with one patient succumbing to the disease when enrolled on maximal ventilatory support and severe hypoxia. The study design was altered by the IRB such that the last 6 patients received higher dose of intravenous hAF. In this latter group, patients that had observed reductions in C-reactive protein were associated with improved clinical outcomes. No hAF-related adverse events were noted. Acknowledging some of the inherent limitations of this case series, these results inform and catalyze a larger scaled randomized prospective trial to further investigate hAF as a therapy for COVID-19. Trial Registration ClinicalTrials.gov: NCT04319731; March 23, 2020.

Keywords: Amniotic fluid; C-reactive protein; COVID-19; Inflammation.

Conflict of interest statement

Drs. Pierce and Phillips are members of the Department of Medicine and administratively direct the Center for Translational and Regenerative Medicine (CTRM) where the human amniotic fluid is processed and subsequently delivered for clinical use. The CTRM has a number of patents with the University of Utah with regards to the utilization of human amniotic fluid for other disease processes (for example, graft versus host disease). The remaining authors have no competing interests.

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Source: PubMed

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