Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients

Summary

The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.

Timeline

Start

2020-10-28

Primary completion

2022-08-02

Completion

2023-02-15

Outcome

Missed primary endpoint

paper were no more likely to have improvements in CRP from baseline to Day 6 than patients who were randomized to placebo PMID 38066442 ↗

paper hAF: -5.9 [IQR -8.2, -0.6] vs placebo: -5.9 [-9.4, -2.05]; p = 0.6077). PMID 38066442 ↗

Publications

• Tonna JE, Pierce J, Brintz BJ, Bardsley T, Hatton N, Lewis G, Phillips JD, Skidmore CR, Selzman CH. A randomized, double-blinded, placebo-controlled clinical trial of sterile filtered human amniotic fluid for treatment of COVID-19. BMC Infect Dis. 2023 Dec 8;23(1):864. doi: 10.1186/s12879-023-08856-y.
• Tonna JE, Pierce J, Hatton N, Lewis G, Phillips JD, Messina A, Skidmore CR, Taylor K, Selzman CH. Safety and feasibility of using acellular sterile filtered amniotic fluid as a treatment for patients with COVID-19: protocol for a randomised, double-blinded, placebo-controlled clinical trial. BMJ Open. 2021 Feb 11;11(2):e045162. doi: 10.1136/bmjopen-2020-045162.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Human Amniotic Fluid	Unknown	10 ml	Intravenous

Indications