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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

Tracking Information
First Submitted Date  ICMJE June 9, 2020
First Posted Date  ICMJE August 4, 2020
Last Update Posted Date November 6, 2020
Actual Study Start Date  ICMJE October 28, 2020
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 3, 2020)
  • Death within 30 Days [ Time Frame: Baseline through 30 days ]
    Comparison of mortality between intervention and control groups
  • ICU-free days at 30 days [ Time Frame: Baseline through 30 days ]
    Comparison of days spend in ICU between intervention and control groups
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE SARS CoV-2
Intervention  ICMJE Biological: Human Amniotic Fluid
Patients will receive 10ml intravenous hAF each day for 5 consecutive days.
Study Arms  ICMJE
  • Experimental: Intervention
    10ml intravenous hAF QD for 5 consecutive days
    Intervention: Biological: Human Amniotic Fluid
  • No Intervention: Standard of Care
    10 mL normal saline QD for 5 days
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2021
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Craig Selzman, MD 8015815311 craig.selzman@hsc.utah.edu
Contact: Alyssa Messina, MA 8015853752 alyssa.messina@hsc.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04497389
Other Study ID Numbers  ICMJE 132922
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Craig Selzman, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Craig Selzman, MD University of Utah
PRS Account University of Utah
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP