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

Primary Purpose

SARS CoV-2

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Human Amniotic Fluid
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS CoV-2 focused on measuring Amniotic fluid, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

  1. Patients on invasive mechanical ventilation (e.g., endotracheal intubation)
  2. Chronic home oxygen utilization
  3. Home or current use of immunosuppressive medications (including steroids)
  4. Women who are pregnant, breastfeeding, or become pregnant during the study
  5. Patients on non-invasive positive pressure ventilation
  6. Patients on >12 liters per minute via non-rebreather (NRB) or >80% oxygen via high flow nasal cannula
  7. Patients who, in the opinion of the PI, have impending respiratory failure, defined as requiring rapidly escalating oxygen supplementation
  8. Patients with a hemoglobin <9 mg/dL
  9. Patients diagnosed with Stage 4 or 5 chronic kidney disease (CKD)
  10. Patients with diagnosed NYHA class 4 or 5 congestive heart failure
  11. Patients with a left ventricular assist device (LVAD)
  12. Patients with thromboembolic phenomena
  13. Patients with Type 2 and above heart block
  14. Patients with established positive bacterial blood cultures prior to enrollment
  15. Patients with ongoing pericardial effusion or ascites
  16. Patients with clinically significant arrhythmia
  17. Patients with liver function tests (ALT or AST) >3x normal
  18. Patients with untreated HIV infection
  19. Patients diagnosed with end-stage organ disease

Sites / Locations

  • University of Utah HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Standard of Care

Arm Description

10ml intravenous hAF QD for 5 consecutive days

10 mL normal saline QD for 5 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 9, 2020
Last Updated
November 4, 2020
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT04497389
Brief Title
Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients
Official Title
A Phase I/II Randomized Double-blinded Placebo-controlled Clinical Trial to Determine Safety and Feasibility of Using an Acellular Sterile Filtered Amniotic Fluid as a Treatment for COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.
Detailed Description
Past use of human amniotic products (i.e., membrane and fluid) has previously been FDA-approved as a human cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) under 21 CFR 1271 for tissue injury; and has been used to reduce inflammation and fibrosis in patients with a variety of ailments. Given this, the investigators hypothesize that intravenously (IV) administered processed sterile filtered amniotic fluid will reduce inflammation in COVID-19 patients, and improve secondary clinical outcomes. Specifically, the investigators hypothesize that patients who receive IV administered hAF will see a 50% reduction in mean C-reactive protein levels following treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS CoV-2
Keywords
Amniotic fluid, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
10ml intravenous hAF QD for 5 consecutive days
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
10 mL normal saline QD for 5 days
Intervention Type
Biological
Intervention Name(s)
Human Amniotic Fluid
Intervention Description
Patients will receive 10ml intravenous hAF each day for 5 consecutive days.
Primary Outcome Measure Information:
Title
C-reactive protein
Description
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
Time Frame
Baseline through post-treatment (6 days)
Other Pre-specified Outcome Measures:
Title
Death within 30 Days
Description
Comparison of mortality between intervention and control groups
Time Frame
Baseline through 30 days
Title
ICU-free days at 30 days
Description
Comparison of days spend in ICU between intervention and control groups
Time Frame
Baseline through 30 days
Title
Hospital length of stay
Description
Comparison of days spent in hospital between intervention and control groups
Time Frame
From date of hospital admission through date of discharge or death, whichever comes first (up to 100 days)
Title
Need for invasive mechanical ventilation
Description
Comparison of mechanical ventilation incidence between intervention and control groups
Time Frame
From date of enrollment through date of discharge or death, whichever comes first (up to 100 days)
Title
Biomarker levels (interleukin-6)
Description
Comparison of mean biomarker level change between intervention and control groups. Units: pg/mL
Time Frame
Baseline through post-treatment (6 days)
Title
Biomarker levels (d-dimer)
Description
Comparison of mean biomarker level change between intervention and control groups. Units: ug/mL
Time Frame
Baseline through post-treatment (6 days)
Title
Biomarker levels (lactate dehydrogenase)
Description
Comparison of mean biomarker level change between intervention and control groups. Units: u/L
Time Frame
Baseline through post-treatment (6 days)
Title
Need for ECMO
Description
Comparison of ECMO incidence between intervention and control groups
Time Frame
From date of enrollment through date of discharge or death, whichever comes first (up to 100 days)
Title
Major adverse cardiac events
Description
Compare frequency of major adverse cardiac events (MACE) between intervention and control groups
Time Frame
From date of enrollment through date of discharge or death, whichever comes first (up to 100 days)
Title
Patient-reported functional status
Description
Comparison of PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire results on a computer-adaptive platform between intervention and control groups using T-scores. Scale mean = 50, standard deviation = 10.
Time Frame
Administered at 1, 3, 6, and 12 months post discharge (1 year)
Title
PTSD Checklist
Description
Patients will be administered a 20-question self-report measure of PTSD symptoms. Total scores range from 0-80. Scores of 31-33 or above generally indicate clinically likely PTSD.
Time Frame
Administered at 1, 3, 6, and 12 months post discharge (1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 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. Exclusion criteria: 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 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 Patients with clinically significant arrhythmia Patients with liver function tests (ALT or AST) >3x normal Patients with untreated HIV infection Patients diagnosed with end-stage organ disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig Selzman, MD
Phone
8015815311
Email
craig.selzman@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Messina, MA
Phone
8015853752
Email
alyssa.messina@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Selzman, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Selzman, MD
Phone
801-581-5311
Email
craig.selzman@hsc.utah.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
33574155
Citation
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.
Results Reference
derived

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

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