SARS CoV-2 InfectionEarly Phase 1NCT04319731
A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
A Early Phase 1 study testing Human Amniotic Fluid in people with SARS CoV-2 Infection, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV-2 Infection
- 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2020to 9 Jun 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- 1. Age ≥18
- 2. Hospitalized and symptomatic (cough, fevers, SOB, or sputum production)
- 3. SARS CoV-2 laboratory positive obtained within 14 days of enrollment
Who cannot join
- 1. None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health
Salt Lake City, Utah, 84132
About this study
The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.
- Conditions
- SARS CoV-2 Infection
- Being tested
- Human Amniotic Fluid
- Keywords
- Amniotic fluid, Respiratory failure, Critical illness
- Medical subject headings
- COVID-19, Respiratory Insufficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Amniotic FluidBiological
Administration of amniotic fluid in SARS-CoV-2 positive patients
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment groups:
1. Acute care and ICU - 10mL intravenous amniotic fluid every 24 hours for 5 days (6mL) Receives: Biological: Human Amniotic Fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator Free Days
Days alive and off mechanical ventilation at day 60. Measured only among patients who receive invasive mechanical ventilation.
Measured: Measured from hospital admission day 60 after admission.
Duration of supplemental oxygen use
Duration from hospital admission until cessation of supplemental oxygen use. Measured only among patients who do not receive invasive mechanical ventilation.
Measured: Measured from hospital admission to day 60.
Secondary outcomes (2)
All cause mortality
Survival at day 60 or hospital discharge
Measured: Measured at day 60 or at hospital discharge, whichever comes first.
Systemic inflammation
Systemic inflammation at 5 days measured by serum IL-6.
Measured: Measured at day 5 post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start20 Mar 2020
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS CoV-2 InfectionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig Selzman, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319731
- Sponsor's protocol ID
- 131618
- Status last verified
- Apr 2020
- First submitted
- 22 Mar 2020
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Selzman CH, Tonna JE, Pierce J, Vargas C, Skidmore C, Lewis G, Hatton ND, Phillips JD. A pilot trial of human amniotic fluid for the treatment of COVID-19. BMC Res Notes. 2021 Jan 22;14(1):32. doi: 10.1186/s13104-021-05443-9.
PubMed 33482902
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
- ClinicalTrials.gov ID
- NCT04319731
- Acronym / sponsor ID
- 131618
- Conditions
- SARS CoV-2 Infection
- Keywords
- Amniotic fluid, Respiratory failure, Critical illness
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
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 test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Human Amniotic FluidTreatment groups: 1. Acute care and ICU - 10mL intravenous amniotic fluid every 24 hours for 5 days (6mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Age ≥18
- 2. Hospitalized and symptomatic (cough, fevers, SOB, or sputum production)
- 3. SARS CoV-2 laboratory positive obtained within 14 days of enrollment
Key exclusion criteria (1 listed)
- 1. None
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 FluidAdministration of amniotic fluid in SARS-CoV-2 positive patients | Biological | Treatment |
Primary outcome
Ventilator Free Days
Time frame: Measured from hospital admission day 60 after admission.
Days alive and off mechanical ventilation at day 60. Measured only among patients who receive invasive mechanical ventilation.
Duration of supplemental oxygen use
Time frame: Measured from hospital admission to day 60.
Duration from hospital admission until cessation of supplemental oxygen use. Measured only among patients who do not receive invasive mechanical ventilation.
2 secondary outcomes
All cause mortality
Time frame: Measured at day 60 or at hospital discharge, whichever comes first.
Systemic inflammation
Time frame: Measured at day 5 post enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Derived from this study: PubMed 33482902Selzman CH, Tonna JE, Pierce J, Vargas C, Skidmore C, Lewis G, Hatton ND, Phillips JD. A pilot trial of human amniotic fluid for the treatment of COVID-19. BMC Res Notes. 2021 Jan 22;14(1):32. doi: 10.1186/s13104-021-05443-9.
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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 Early Phase 1 study testing Human Amniotic Fluid in people with SARS CoV-2 Infection, 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 3 inclusion and 1 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 24 Apr 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ventilator Free Days (time frame: Measured from hospital admission day 60 after admission.). The study lists 2 primary outcomes in all. 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 NCT04319731, which also lists 1 linked publication.
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 24 Apr 2023.