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

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ClinicalTrials.gov Identifier: NCT04497389
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Craig Selzman, University of Utah

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

Condition or disease Intervention/treatment Phase
SARS CoV-2 Biological: Human Amniotic Fluid Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : September 15, 2021

Arm Intervention/treatment
Experimental: Intervention
10ml intravenous hAF QD for 5 consecutive days
Biological: Human Amniotic Fluid
Patients will receive 10ml intravenous hAF each day for 5 consecutive days.

No Intervention: Standard of Care
10 mL normal saline QD for 5 days



Primary Outcome Measures :
  1. C-reactive protein [ Time Frame: Baseline through post-treatment (6 days) ]
    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


Other Outcome Measures:
  1. Death within 30 Days [ Time Frame: Baseline through 30 days ]
    Comparison of mortality between intervention and control groups

  2. ICU-free days at 30 days [ Time Frame: Baseline through 30 days ]
    Comparison of days spend in ICU between intervention and control groups

  3. Hospital length of stay [ Time Frame: From date of hospital admission through date of discharge or death, whichever comes first (up to 100 days) ]
    Comparison of days spent in hospital between intervention and control groups

  4. Need for invasive mechanical ventilation [ Time Frame: From date of enrollment through date of discharge or death, whichever comes first (up to 100 days) ]
    Comparison of mechanical ventilation incidence between intervention and control groups

  5. Biomarker levels (interleukin-6) [ Time Frame: Baseline through post-treatment (6 days) ]
    Comparison of mean biomarker level change between intervention and control groups. Units: pg/mL

  6. Biomarker levels (d-dimer) [ Time Frame: Baseline through post-treatment (6 days) ]
    Comparison of mean biomarker level change between intervention and control groups. Units: ug/mL

  7. Biomarker levels (lactate dehydrogenase) [ Time Frame: Baseline through post-treatment (6 days) ]
    Comparison of mean biomarker level change between intervention and control groups. Units: u/L

  8. Need for ECMO [ Time Frame: From date of enrollment through date of discharge or death, whichever comes first (up to 100 days) ]
    Comparison of ECMO incidence between intervention and control groups

  9. Major adverse cardiac events [ Time Frame: From date of enrollment through date of discharge or death, whichever comes first (up to 100 days) ]
    Compare frequency of major adverse cardiac events (MACE) between intervention and control groups

  10. Patient-reported functional status [ Time Frame: Administered at 1, 3, 6, and 12 months post discharge (1 year) ]
    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.

  11. PTSD Checklist [ Time Frame: Administered at 1, 3, 6, and 12 months post discharge (1 year) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497389


Contacts
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Contact: Craig Selzman, MD 8015815311 craig.selzman@hsc.utah.edu
Contact: Alyssa Messina, MA 8015853752 alyssa.messina@hsc.utah.edu

Locations
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United States, Utah
University of Utah Health Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Craig Selzman, MD    801-581-5311    craig.selzman@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Craig Selzman, MD University of Utah
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Craig Selzman, Principle Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT04497389    
Other Study ID Numbers: 132922
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020

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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
Keywords provided by Craig Selzman, University of Utah:
Amniotic fluid
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases