SARS CoV-2Phase 1/2NCT04497389
Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients
A Phase 1/2 study testing Human Amniotic Fluid in people with SARS CoV-2, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV-2
- What is being tested?
- Human Amniotic Fluid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2020to 15 Feb 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health
Salt Lake City, Utah, 84132
About this study
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
The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.
Read the 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.
Data sharing: Trial results will be published in peer reviewed publications upon completion of analysis.
- Conditions
- SARS CoV-2
- Being tested
- Human Amniotic Fluid
- Keywords
- Amniotic fluid, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Amniotic FluidBiological
Patients will receive 10ml intravenous hAF each day for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 10ml intravenous hAF QD (once daily) for 5 consecutive days Receives: Biological: Human Amniotic Fluid |
| Standard of Care | No intervention | 10 mL normal saline QD (once daily) for 5 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline through post-treatment (6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start28 Oct 2020
- Primary completion2 Aug 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS CoV-2Studies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Selzman, University of Utah
- Investigators
- Craig Selzman, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497389
- Sponsor's protocol ID
- 132922
- Status last verified
- Dec 2023
- First submitted
- 9 Jun 2020
- Last updated
- 21 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 38066442Tonna 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.
PubMed 33574155
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04497389
- Acronym / sponsor ID
- 132922
- Conditions
- SARS CoV-2
- Keywords
- Amniotic fluid, COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Posted 21 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Data sharing: Trial results will be published in peer reviewed publications upon completion of analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: Human Amniotic Fluid10ml intravenous hAF QD (once daily) for 5 consecutive days |
| Standard of Care | No intervention | –10 mL normal saline QD (once daily) for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Amniotic FluidPatients will receive 10ml intravenous hAF each day for 5 consecutive days. | Biological | Intervention |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38066442Tonna 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.
- Derived from this study: PubMed 33574155Tonna 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Selzman, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human Amniotic Fluid in people with SARS CoV-2, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive Protein (time frame: Baseline through post-treatment (6 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04497389, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.