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

SARS CoV-2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497389
• Other study ID #: 132922
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 28, 2020
• Est. completion date: February 15, 2023

Study information

• Verified date: December 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 15, 2023
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 investigational product (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 New York Heart Association (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

Related Conditions & MeSH terms

• COVID-19
• SARS CoV-2

Intervention

Biological:
• Human Amniotic Fluid
Patients will receive 10ml intravenous hAF each day for 5 consecutive days.

Locations

Country	Name	City	State
United States	University of Utah Health	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death Within 30 Days	Comparison of mortality between intervention and control groups	Baseline through 30 days
Other	Any ICU Admission	Comparison of ICU admissions between intervention and control groups	Baseline through 30 days
Other	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)
Other	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)
Other	Biomarker Levels (Interleukin-6)	Comparison of mean biomarker level change between intervention and control groups. Units: pg/mL	Baseline through post-treatment (6 days)
Other	Biomarker Levels (D-dimer)	Comparison of mean biomarker level change between intervention and control groups. Units: mg/mL	Baseline through post-treatment (6 days)
Other	Biomarker Levels (Lactate Dehydrogenase)	Comparison of mean biomarker level change between intervention and control groups. Units: u/L	Baseline through post-treatment (6 days)
Other	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)
Other	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)
Other	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
Other	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
Other	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
Other	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
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	Baseline through post-treatment (6 days)