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Completed

NCT Number: NCT04497389

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

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

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Key information

Conditions

SARS CoV-2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Utah Health

Salt Lake City, Utah, 84132, United States

About this study

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.

Data sharing: Trial results will be published in peer reviewed publications upon completion of analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

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 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
  • 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

Treatment and study plan

Human Amniotic Fluid

Biological

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

Primary outcomes

  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 outcomes

  1. Death Within 30 Days

    Time frame: Baseline through 30 days

    Comparison of mortality between intervention and control groups

  2. Any ICU Admission

    Time frame: Baseline through 30 days

    Comparison of ICU admissions 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: mg/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 at 1 Month

    Time frame: 1 month post-discharge

    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. Higher scores indicate more of the concept being measured (i.e., physical function = a higher score indicates better outcomes; dyspnea severity, sleep disturbance, anxiety = a higher score indicates worse outcomes).

    Sleep Disturbance, Dyspnea Severity, Anxiety Less than 55 = None to slight/Within normal limits 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe

    Physical Function 55 and over = Within normal limits 54.9-40 = Mild limitations 39.9-30 = Moderate limitations 29.9 and below = Severe limitations

  11. Patient-reported Functional Status at 3 Months

    Time frame: 3 months post-discharge

    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. Higher scores indicate more of the concept being measured (i.e., physical function = a higher score indicates better outcomes; dyspnea severity, sleep disturbance, anxiety = a higher score indicates worse outcomes).

    Sleep Disturbance, Dyspnea Severity, Anxiety Less than 55 = None to slight/Within normal limits 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe

    Physical Function 55 and over = Within normal limits 54.9-40 = Mild limitations 39.9-30 = Moderate limitations 29.9 and below = Severe limitations

  12. Patient-reported Functional Status at 6 Months

    Time frame: 6 months post-discharge

    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. Higher scores indicate more of the concept being measured (i.e., physical function = a higher score indicates better outcomes; dyspnea severity, sleep disturbance, anxiety = a higher score indicates worse outcomes).

    Sleep Disturbance, Dyspnea Severity, Anxiety Less than 55 = None to slight/Within normal limits 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe

    Physical Function 55 and over = Within normal limits 54.9-40 = Mild limitations 39.9-30 = Moderate limitations 29.9 and below = Severe limitations

  13. Patient-reported Functional Status at 12 Months

    Time frame: 12 months post-discharge

    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. Higher scores indicate more of the concept being measured (i.e., physical function = a higher score indicates better outcomes; dyspnea severity, sleep disturbance, anxiety = a higher score indicates worse outcomes).

    Sleep Disturbance, Dyspnea Severity, Anxiety Less than 55 = None to slight/Within normal limits 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe

    Physical Function 55 and over = Within normal limits 54.9-40 = Mild limitations 39.9-30 = Moderate limitations 29.9 and below = Severe limitations

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 4, 2020
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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