Trial Outcomes & Findings for Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients (NCT NCT04497389)

Last Updated: 2023-12-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Baseline through post-treatment (6 days)

Results posted on

2023-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care 10 mL normal saline QD for 5 days
Overall Study STARTED	23	24
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care 10 mL normal saline QD for 5 days
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=23 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=24 Participants 10 mL normal saline QD for 5 days	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous	56.8 years STANDARD_DEVIATION 16.09 • n=5 Participants	58.8 years STANDARD_DEVIATION 12.8 • n=7 Participants	57.8 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through post-treatment (6 days)

Outcome measures

Outcome measures
Measure	Intervention n=23 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=24 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
C-reactive Protein	-3.6 mg/dL Standard Deviation 8.58	-5.5 mg/dL Standard Deviation 5.42	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 30 days

Comparison of mortality between intervention and control groups

Outcome measures

Outcome measures
Measure	Intervention n=23 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=24 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Death Within 30 Days	2 Participants	0 Participants	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 30 days

Comparison of ICU admissions between intervention and control groups

Outcome measures

Outcome measures
Measure	Intervention n=22 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=24 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Any ICU Admission	8 Participants	4 Participants	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=23 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=24 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Hospital Length of Stay	7.4 days Standard Deviation 6.69	7 days Standard Deviation 6.04	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=23 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=24 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Need for Invasive Mechanical Ventilation	4 Participants	1 Participants	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through post-treatment (6 days)

Population: Data is missing for patients who did not have Day 6 labs drawn.

Comparison of mean biomarker level change between intervention and control groups. Units: pg/mL

Outcome measures

Outcome measures
Measure	Intervention n=17 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=15 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Biomarker Levels (Interleukin-6)	9.4 pg/mL Standard Deviation 24.11	32 pg/mL Standard Deviation 107.77	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through post-treatment (6 days)

Population: Data is missing for patients who did not have Day 6 labs drawn.

Comparison of mean biomarker level change between intervention and control groups. Units: mg/mL

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=16 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Biomarker Levels (D-dimer)	-0.3 mg/mL Standard Deviation 1.77	1.8 mg/mL Standard Deviation 11.8	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through post-treatment (6 days)

Population: Data is missing for patients who did not have Day 6 labs drawn.

Comparison of mean biomarker level change between intervention and control groups. Units: u/L

Outcome measures

Outcome measures
Measure	Intervention n=18 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=14 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Biomarker Levels (Lactate Dehydrogenase)	-87.3 U/L Standard Deviation 124.8	-54.4 U/L Standard Deviation 80.8	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=23 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=24 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Need for ECMO	0 Participants	0 Participants	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=23 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=24 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Major Adverse Cardiac Events	1 Participants	0 Participants	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month post-discharge

Population: Data is missing for patients who did not complete Month 1 surveys.

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

Outcome measures

Outcome measures
Measure	Intervention n=11 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=13 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention n=11 Participants Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control n=13 Participants Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention n=11 Participants Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control n=13 Participants Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention n=11 Participants Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control n=13 Participants Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Patient-reported Functional Status at 1 Month	39.8 t-score Standard Deviation 8.54	41.5 t-score Standard Deviation 9.10	41.6 t-score Standard Deviation 9.36	43.0 t-score Standard Deviation 9.71	47.8 t-score Standard Deviation 9.81	52.2 t-score Standard Deviation 4.98	47.0 t-score Standard Deviation 9.18	51.1 t-score Standard Deviation 47.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months post-discharge

Population: Data is missing for patients who did not complete Month 3 surveys.

Outcome measures

Outcome measures
Measure	Intervention n=11 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=13 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention n=11 Participants Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control n=13 Participants Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention n=11 Participants Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control n=13 Participants Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention n=11 Participants Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control n=13 Participants Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Patient-reported Functional Status at 3 Months	42.9 t-score Standard Deviation 7.30	43.9 t-score Standard Deviation 10.4	37.2 t-score Standard Deviation 10.3	41.5 t-score Standard Deviation 14.8	45.4 t-score Standard Deviation 10.8	50.5 t-score Standard Deviation 8.55	43.6 t-score Standard Deviation 6.87	50.9 t-score Standard Deviation 7.84

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months post-discharge

Population: Data is missing for patients who did not complete Month 6 surveys.

Outcome measures

Outcome measures
Measure	Intervention n=8 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=11 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention n=8 Participants Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control n=11 Participants Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention n=8 Participants Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control n=11 Participants Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention n=8 Participants Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control n=11 Participants Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Patient-reported Functional Status at 6 Months	45.0 t-score Standard Deviation 6.30	44.3 t-score Standard Deviation 11.6	37.6 t-score Standard Deviation 9.21	37.2 t-score Standard Deviation 10.8	48.0 t-score Standard Deviation 10.2	47.1 t-score Standard Deviation 6.84	39.4 t-score Standard Deviation 3.23	51.7 t-score Standard Deviation 8.46

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-discharge

Population: Data missing from patients who did not complete Month 12 surveys.

Outcome measures

Outcome measures
Measure	Intervention n=5 Participants 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=11 Participants 10 mL normal saline QD for 5 days	Month 1 PROMIS Dyspnea Severity: Intervention n=5 Participants Results from self-reported PROMIS Dyspnea Severity at 1 month post-discharge, intervention group	Month 1 PROMIS Dyspnea Severity: Control n=11 Participants Results from self-reported PROMIS Physical Function at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Intervention n=5 Participants Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, intervention group	Month 1 PROMIS Sleep Disturbance: Control n=11 Participants Results from self-reported PROMIS Sleep Disturbance at 1 month post-discharge, control group	Month 1 PROMIS Anxiety: Intervention n=5 Participants Results from self-reported PROMIS Anxiety at 1 month post-discharge, intervention group	Month 1 PROMIS Anxiety: Control n=11 Participants Results from self-reported PROMIS Anxiety at 1 month post-discharge, control group
Patient-reported Functional Status at 12 Months	51.8 t-score Standard Deviation 9.66	42.9 t-score Standard Deviation 10.9	31.8 t-score Standard Deviation 8.62	41.6 t-score Standard Deviation 12.3	47.1 t-score Standard Deviation 12.6	49.9 t-score Standard Deviation 7.64	42.3 t-score Standard Deviation 5.73	47.4 t-score Standard Deviation 9.38

Adverse Events

Intervention

Serious events: 5 serious events

Other events: 13 other events

Deaths: 2 deaths

Standard of Care

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=23 participants at risk 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=24 participants at risk 10 mL normal saline QD for 5 days
General disorders Shock leading to death	4.3% 1/23 • Number of events 1 • 6 months	0.00% 0/24 • 6 months
General disorders Shock leading to readmission	4.3% 1/23 • Number of events 1 • 6 months	0.00% 0/24 • 6 months
Cardiac disorders STEMI	4.3% 1/23 • Number of events 1 • 6 months	0.00% 0/24 • 6 months
Respiratory, thoracic and mediastinal disorders Readmission for COVID-19 pneumonia	4.3% 1/23 • Number of events 1 • 6 months	4.2% 1/24 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Readmission for ARDS	4.3% 1/23 • Number of events 1 • 6 months	0.00% 0/24 • 6 months
General disorders Readmission for COVID-19 symptoms	0.00% 0/23 • 6 months	4.2% 1/24 • Number of events 1 • 6 months

Other adverse events

Other adverse events
Measure	Intervention n=23 participants at risk 10ml intravenous hAF QD for 5 consecutive days Human Amniotic Fluid: Patients will receive 10ml intravenous hAF each day for 5 consecutive days.	Standard of Care n=24 participants at risk 10 mL normal saline QD for 5 days
Metabolism and nutrition disorders Abnormal Metabolic Panel	17.4% 4/23 • Number of events 9 • 6 months	8.3% 2/24 • Number of events 4 • 6 months
Blood and lymphatic system disorders Abnormal CBC	17.4% 4/23 • Number of events 5 • 6 months	12.5% 3/24 • Number of events 4 • 6 months
Hepatobiliary disorders Abnormal Hepatic Panel	4.3% 1/23 • Number of events 7 • 6 months	8.3% 2/24 • Number of events 4 • 6 months
Cardiac disorders Elevated Blood Pressure	4.3% 1/23 • Number of events 2 • 6 months	0.00% 0/24 • 6 months
Cardiac disorders Hypotension	21.7% 5/23 • Number of events 27 • 6 months	16.7% 4/24 • Number of events 7 • 6 months
Cardiac disorders Tachycardia	21.7% 5/23 • Number of events 9 • 6 months	12.5% 3/24 • Number of events 6 • 6 months
Cardiac disorders Bradycardia	13.0% 3/23 • Number of events 4 • 6 months	16.7% 4/24 • Number of events 8 • 6 months
General disorders ED visits	8.7% 2/23 • Number of events 3 • 6 months	4.2% 1/24 • Number of events 1 • 6 months
Renal and urinary disorders Positive urine culture	8.7% 2/23 • Number of events 2 • 6 months	0.00% 0/24 • 6 months
General disorders Abnormal Blood Gas	8.7% 2/23 • Number of events 30 • 6 months	4.2% 1/24 • Number of events 2 • 6 months
Respiratory, thoracic and mediastinal disorders Intubation	17.4% 4/23 • Number of events 5 • 6 months	4.2% 1/24 • Number of events 1 • 6 months
Cardiac disorders Elevated troponin	8.7% 2/23 • Number of events 2 • 6 months	0.00% 0/24 • 6 months
Cardiac disorders Abnormal ECG	4.3% 1/23 • Number of events 1 • 6 months	0.00% 0/24 • 6 months
Cardiac disorders Abnormal Echocardiogram	8.7% 2/23 • Number of events 2 • 6 months	0.00% 0/24 • 6 months
General disorders Fall	4.3% 1/23 • Number of events 1 • 6 months	0.00% 0/24 • 6 months
Endocrine disorders Type 2 Diabetes	4.3% 1/23 • Number of events 1 • 6 months	0.00% 0/24 • 6 months
Respiratory, thoracic and mediastinal disorders Positive respiratory cultures	8.7% 2/23 • Number of events 2 • 6 months	0.00% 0/24 • 6 months
General disorders Back pain	4.3% 1/23 • Number of events 1 • 6 months	0.00% 0/24 • 6 months
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/23 • 6 months	4.2% 1/24 • Number of events 2 • 6 months
Gastrointestinal disorders Abdominal pain	0.00% 0/23 • 6 months	4.2% 1/24 • Number of events 1 • 6 months

Additional Information

Joseph Tonna, MD

University of Utah

Phone: 801-587-6271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place