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

NCT04497389 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 132922
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

SARS CoV-2

Keywords

Amniotic fluid; COVID-19

Outcome Measures

Primary Outcomes (1)

• C-reactive Protein

  Assess reduction of inflammation in COVID-19 patients, potentially leading to a decrease in the need for critical care. This will be assessed by measurement of C-reactive protein levels before and after the intervention. Units: mg/dL

  Baseline through post-treatment (6 days)

Other Outcomes (13)

• Death Within 30 Days

  Baseline through 30 days

• Any ICU Admission

  Baseline through 30 days

• Hospital Length of Stay

  From date of hospital admission through date of discharge or death, whichever comes first (up to 100 days)

Study Arms (2)

Intervention

EXPERIMENTAL

10ml intravenous hAF QD (once daily) for 5 consecutive days

Biological: Human Amniotic Fluid

Standard of Care

NO INTERVENTION

10 mL normal saline QD (once daily) for 5 days

Interventions

Human Amniotic Fluid BIOLOGICAL

Patients will receive 10ml intravenous hAF each day for 5 consecutive days.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• SARS CoV-2 laboratory positive test, obtained within 14 days of enrollment
• Hospitalized
• COVID-19 symptomatic (cough, fevers, shortness of breath, and/or sputum production)
• Has a room air pulse oximetry of ≤94% and requires supplemental oxygen therapy
• Patients of childbearing potential who agree to use acceptable methods of contraception for 90 days after last administration of study investigational product (IP)
• Patients who are receiving standard of care therapies for COVID-19 that are not FDA approved are eligible for this study
• Subjects must be able to consent to the study (i.e., Glasgow Coma Scale score of ≥14)
• Patients are required to have controlled blood pressure of \<160/96 and a pulse of \<110.

You may not qualify if:

• Patients on invasive mechanical ventilation (e.g., endotracheal intubation)
• Chronic home oxygen utilization
• Home or current use of immunosuppressive medications (including steroids)
• Women who are pregnant, breastfeeding, or become pregnant during the study
• Patients on non-invasive positive pressure ventilation
• Patients on \>12 liters per minute via non-rebreather (NRB) or \>80% oxygen via high flow nasal cannula
• Patients who, in the opinion of the PI, have impending respiratory failure, defined as requiring rapidly escalating oxygen supplementation
• Patients with a hemoglobin \<9 mg/dL
• Patients diagnosed with Stage 4 or 5 chronic kidney disease (CKD)
• Patients with diagnosed New York Heart Association (NYHA) class 4 or 5 congestive heart failure
• Patients with a left ventricular assist device (LVAD)
• Patients with thromboembolic phenomena
• Patients with Type 2 and above heart block
• Patients with established positive bacterial blood cultures prior to enrollment
• Patients with ongoing pericardial effusion or ascites

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

Related Publications (2)

• 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.

  PMID: 38066442 DERIVED

• 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.

  PMID: 33574155 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

amniotic fluid peptide-1, human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Joseph Tonna, MD
• Organization: University of Utah

joseph.tonna@hsc.utah.edu

801-587-6271

Study Officials

• Craig Selzman, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: August 4, 2020
• Study Start: October 28, 2020
• Primary Completion: August 2, 2022
• Study Completion: February 15, 2023
• Last Updated: December 21, 2023
• Results First Posted: December 21, 2023

Record last verified: 2023-12

Locations

US (1)