NCT04319731

A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure

Completed EARLY_PHASE1 Last updated 24 April 2023

What this trial tests

EARLY_PHASE1 trial testing Human Amniotic Fluid in SARS CoV-2 Infection in 10 participants. Completed in 9 June 2020.

Timeline

20 March 2020

Primary endpoint
9 June 2020

9 June 2020

Quick facts

Lead sponsor	University of Utah
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	20 March 2020
Primary completion	9 June 2020
Estimated completion	9 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Human Amniotic Fluid — full drug profile →

Conditions studied

• SARS CoV-2 Infection — all drugs for SARS CoV-2 Infection →

Sponsor

University of Utah

Who can join

18 and older, any sex, with SARS CoV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID-19: The Potential Treatment of Pulmonary Fibrosis Associated with SARS-CoV-2 Infection.
   Lechowicz K, Drożdżal S, Machaj F, Rosik J, et al · · 2020 · cited 110× · PMID 32575380 · DOI 10.3390/jcm9061917
2. The current understanding and potential therapeutic options to combat COVID-19.
   Pooladanda V, Thatikonda S, Godugu C. · · 2020 · cited 56× · PMID 32437797 · DOI 10.1016/j.lfs.2020.117765
3. Current Status and Future Prospects of Perinatal Stem Cells.
   Torre P, Flores AI. · · 2020 · cited 47× · PMID 33374593 · DOI 10.3390/genes12010006
4. Placental transfer and safety in pregnancy of medications under investigation to treat coronavirus disease 2019.
   Louchet M, Sibiude J, Peytavin G, Picone O, et al · · 2020 · cited 34× · PMID 32838264 · DOI 10.1016/j.ajogmf.2020.100159
5. Review of registered clinical trials for the treatment of COVID-19.
   Babaei F, Mirzababaei M, Nassiri-Asl M, Hosseinzadeh H. · · 2021 · cited 31× · PMID 33251593 · DOI 10.1002/ddr.21762
6. SARS-CoV-2 Treatment Approaches: Numerous Options, No Certainty for a Versatile Virus.
   Iacob S, Iacob DG. · · 2020 · cited 27× · PMID 32982720 · DOI 10.3389/fphar.2020.01224
7. Revisiting potential druggable targets against SARS-CoV-2 and repurposing therapeutics under preclinical study and clinical trials: A comprehensive review.
   Sohag AAM, Hannan MA, Rahman S, Hossain M, et al · · 2020 · cited 26× · PMID 32632960 · DOI 10.1002/ddr.21709
8. Primed for global coronavirus pandemic: Emerging research and clinical outcome.
   Ahamad S, Branch S, Harrelson S, Hussain MK, et al · · 2021 · cited 25× · PMID 33070079 · DOI 10.1016/j.ejmech.2020.112862