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The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 10ml intravenous hAF QD (once daily) for 5 consecutive days |
|
| Standard of Care | No Intervention | 10 mL normal saline QD (once daily) for 5 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Amniotic Fluid | Biological | Patients will receive 10ml intravenous hAF each day for 5 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Death Within 30 Days | Comparison of mortality between intervention and control groups | Baseline through 30 days |
| Any ICU Admission | Comparison of ICU admissions between intervention and control groups |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Selzman, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Health | Salt Lake City | Utah | 84132 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38066442 | Derived | 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. | |
| 33574155 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days. |
| FG001 | Standard of Care | 10 mL normal saline QD for 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days. |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | mg/dL | Baseline through post-treatment (6 days) |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shock leading to death | General disorders | Systematic Assessment | Multifactorial shock requiring use of multiple vasopressors. Resulted in patient's death. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Metabolic Panel | Metabolism and nutrition disorders | Systematic Assessment | High or low values in basic or comprehensive metabolic panels |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Tonna, MD | University of Utah | 801-587-6271 | joseph.tonna@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2021 | Aug 29, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C523872 | amniotic fluid peptide-1, human |
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| Baseline through 30 days |
| Hospital Length of Stay | Comparison of days spent in hospital between intervention and control groups | From date of hospital admission through date of discharge or death, whichever comes first (up to 100 days) |
| Need for Invasive Mechanical Ventilation | Comparison of mechanical ventilation incidence between intervention and control groups | From date of enrollment through date of discharge or death, whichever comes first (up to 100 days) |
| Biomarker Levels (Interleukin-6) | Comparison of mean biomarker level change between intervention and control groups. Units: pg/mL | Baseline through post-treatment (6 days) |
| Biomarker Levels (D-dimer) | Comparison of mean biomarker level change between intervention and control groups. Units: mg/mL | Baseline through post-treatment (6 days) |
| Biomarker Levels (Lactate Dehydrogenase) | Comparison of mean biomarker level change between intervention and control groups. Units: u/L | Baseline through post-treatment (6 days) |
| Need for ECMO | Comparison of ECMO incidence between intervention and control groups | From date of enrollment through date of discharge or death, whichever comes first (up to 100 days) |
| Major Adverse Cardiac Events | Compare frequency of major adverse cardiac events (MACE) between intervention and control groups | From date of enrollment through date of discharge or death, whichever comes first (up to 100 days) |
| Patient-reported Functional Status at 1 Month | 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 | 1 month post-discharge |
| Patient-reported Functional Status at 3 Months | 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 | 3 months post-discharge |
| Patient-reported Functional Status at 6 Months | 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 | 6 months post-discharge |
| Patient-reported Functional Status at 12 Months | 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 months post-discharge |
| 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. |
10 mL normal saline QD for 5 days
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Other Pre-specified | Death Within 30 Days | Comparison of mortality between intervention and control groups | Posted | Count of Participants | Participants | Baseline through 30 days |
|
|
|
| Other Pre-specified | Any ICU Admission | Comparison of ICU admissions between intervention and control groups | Posted | Number | Participants | Baseline through 30 days |
|
|
|
| Other Pre-specified | Hospital Length of Stay | Comparison of days spent in hospital between intervention and control groups | Posted | Mean | Standard Deviation | days | From date of hospital admission through date of discharge or death, whichever comes first (up to 100 days) |
|
|
|
| Other Pre-specified | Need for Invasive Mechanical Ventilation | Comparison of mechanical ventilation incidence between intervention and control groups | Posted | Count of Participants | Participants | From date of enrollment through date of discharge or death, whichever comes first (up to 100 days) |
|
|
|
| Other Pre-specified | Biomarker Levels (Interleukin-6) | Comparison of mean biomarker level change between intervention and control groups. Units: pg/mL | Data is missing for patients who did not have Day 6 labs drawn. | Posted | Mean | Standard Deviation | pg/mL | Baseline through post-treatment (6 days) |
|
|
|
| Other Pre-specified | Biomarker Levels (D-dimer) | Comparison of mean biomarker level change between intervention and control groups. Units: mg/mL | Data is missing for patients who did not have Day 6 labs drawn. | Posted | Mean | Standard Deviation | mg/mL | Baseline through post-treatment (6 days) |
|
|
|
| Other Pre-specified | Biomarker Levels (Lactate Dehydrogenase) | Comparison of mean biomarker level change between intervention and control groups. Units: u/L | Data is missing for patients who did not have Day 6 labs drawn. | Posted | Mean | Standard Deviation | U/L | Baseline through post-treatment (6 days) |
|
|
|
| Other Pre-specified | Need for ECMO | Comparison of ECMO incidence between intervention and control groups | Posted | Count of Participants | Participants | From date of enrollment through date of discharge or death, whichever comes first (up to 100 days) |
|
|
|
| Other Pre-specified | Major Adverse Cardiac Events | Compare frequency of major adverse cardiac events (MACE) between intervention and control groups | Posted | Count of Participants | Participants | From date of enrollment through date of discharge or death, whichever comes first (up to 100 days) |
|
|
|
| Other Pre-specified | Patient-reported Functional Status at 1 Month | 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 | Data is missing for patients who did not complete Month 1 surveys. | Posted | Mean | Standard Deviation | t-score | 1 month post-discharge |
|
|
|
| Other Pre-specified | Patient-reported Functional Status at 3 Months | 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 | Data is missing for patients who did not complete Month 3 surveys. | Posted | Mean | Standard Deviation | t-score | 3 months post-discharge |
|
|
|
| Other Pre-specified | Patient-reported Functional Status at 6 Months | 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 | Data is missing for patients who did not complete Month 6 surveys. | Posted | Mean | Standard Deviation | t-score | 6 months post-discharge |
|
|
|
| Other Pre-specified | Patient-reported Functional Status at 12 Months | 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 | Data missing from patients who did not complete Month 12 surveys. | Posted | Mean | Standard Deviation | t-score | 12 months post-discharge |
|
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| 2 |
| 23 |
| 5 |
| 23 |
| 13 |
| 23 |
| EG001 | Standard of Care | 10 mL normal saline QD for 5 days | 0 | 24 | 2 | 24 | 11 | 24 |
|
| Shock leading to readmission | General disorders | Systematic Assessment | Septic shock leading to patient's readmission to the hospital. |
|
| STEMI | Cardiac disorders | Systematic Assessment | STEMI which resulted in patient's death |
|
| Readmission for COVID-19 pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Continued symptoms of COVID-19 pneumonia requiring hospital readmission |
|
| Readmission for ARDS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patient developed acute respiratory distress syndrome (ARDS) which required readmission to hospital |
|
| Readmission for COVID-19 symptoms | General disorders | Systematic Assessment | Patient was experiencing continued COVID-19 symptoms and was readmitted to the hospital. |
|
|
| Abnormal CBC | Blood and lymphatic system disorders | Systematic Assessment | Low or high values in complete blood count panel |
|
| Abnormal Hepatic Panel | Hepatobiliary disorders | Systematic Assessment | Low or high values on hepatic blood panel |
|
| Elevated Blood Pressure | Cardiac disorders | Systematic Assessment | Elevated systolic and/or diastolic blood pressure values |
|
| Hypotension | Cardiac disorders | Systematic Assessment | Low systolic and/or diastolic blood pressure values |
|
| Tachycardia | Cardiac disorders | Systematic Assessment | Heart rates above 100 beats per minute |
|
| Bradycardia | Cardiac disorders | Systematic Assessment | Heart rate less than 60 beats per minute |
|
| ED visits | General disorders | Systematic Assessment | Visits to the Emergency Department that did not result in hospital admission (e.g., ongoing cough) |
|
| Positive urine culture | Renal and urinary disorders | Systematic Assessment | Bacteria found in urine culture |
|
| Abnormal Blood Gas | General disorders | Systematic Assessment | Low or high arterial or venous blood gas values |
|
| Intubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patients requiring endotracheal intubation |
|
| Elevated troponin | Cardiac disorders | Systematic Assessment | Elevated blood troponin values |
|
| Abnormal ECG | Cardiac disorders | Systematic Assessment | Abnormal results on electrocardiogram (e.g., bundle branch block) |
|
| Abnormal Echocardiogram | Cardiac disorders | Systematic Assessment | Abnormal results on echocardiogram (e.g., Takotsubo cardiomyopathy) |
|
| Fall | General disorders | Systematic Assessment | Patient fell while inpatient |
|
| Type 2 Diabetes | Endocrine disorders | Systematic Assessment | New diagnosis of Type 2 diabetes |
|
| Positive respiratory cultures | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Bacterial findings in respiratory culture |
|
| Back pain | General disorders | Systematic Assessment | Patient complaint of back pain while inpatient |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Development of pneumothorax |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Patient complaint of abdominal pain while inpatient |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |