Covid19Phase 1NCT04606784
Study of Nebulized Ampion for the Treatment of Adult COVID-19 Patients With Respiratory Distress
A Phase 1 study testing Ampion in people with Covid19, run by Ampio Pharmaceuticals. Inc. at 1 site in United States.
Trial summary
This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of nebulized Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who have respiratory distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Ampion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2020to 15 Jun 2021
- Phase
- 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
- Male or female, ≥ 18 years old.
- Diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-CoV-2, or suspected COVID-19 diagnosis based on radiological clinical findings.
- Respiratory distress as evidenced by at least two of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.)
- Recording of SpO2 ≤ 90% or the patient is requiring supplemental oxygen to maintain an SpO2 ≥ 90%
- Requiring supplemental oxygen
- Diagnosis of mild, moderate, or severe ARDS by Berlin definition
- A signed informed consent form from the patient or the patient's legal representative must be available.
Who cannot join
- In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place
- Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
- Patient is on chronic immunosuppressive medication.
- As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
- A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
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- Patient has known pregnancy or is currently breastfeeding.
- Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access or compassionate use).
- Baseline QT prolongation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Nebulized Ampion In Adults With Respiratory Distress Secondary to COVID-19 Infection
This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of nebulized Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who have respiratory distress.
- Conditions
- Covid19
- Being tested
- Ampion, Standard of Care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmpionBiological
Ampion, nebulized for inhalation
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Ampion | Experimental | Ampion Receives: Biological: Ampion; Other: Standard of Care |
| Standard of Care | Other | Standard of Care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Incidence and severity of adverse events
Measured: Day 5
Incidence and severity of adverse events
Incidence and severity of adverse events
Measured: Day 28
Secondary outcomes (2)
Clinical status using 8-point ordinal scale
Efficacy measures for clinical improvement using 8-point ordinal scale: 0 = Uninfected, 1 = Ambulatory without limitation of activity, 2 = Ambulatory with limitation of activity, 3 = Hospitalized mild disease, no oxygen, 4 = Hospitalized mild disease, supplemental oxygen, 5 = Hospitalized severe disease, non-invasive ventilation or high-flow oxygen, 6 = Hospitalized severe disease, intubation and mechanical ventilation, 7 = Hospitalized severe disease, ventilation plus additional organ support, 8 = Death
Measured: Day 5
Clinical status using 8-point ordinal scale
Efficacy measures for clinical improvement using 8-point ordinal scale: 0 = Uninfected, 1 = Ambulatory without limitation of activity, 2 = Ambulatory with limitation of activity, 3 = Hospitalized mild disease, no oxygen, 4 = Hospitalized mild disease, supplemental oxygen, 5 = Hospitalized severe disease, non-invasive ventilation or high-flow oxygen, 6 = Hospitalized severe disease, intubation and mechanical ventilation, 7 = Hospitalized severe disease, ventilation plus additional organ support, 8 = Death
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start28 Oct 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
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 Covid19Studies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ampio Pharmaceuticals. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606784
- Sponsor's protocol ID
- AP-014
- Status last verified
- Mar 2022
- First submitted
- 27 Oct 2020
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Roshon M, Lemos-Filho L, Cherevka H, Goldberg L, Salottolo K, Bar-Or D. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of a Novel Inhaled Biologic Therapeutic in Adults with Respiratory Distress Secondary to COVID-19 Infection. Infect Dis Ther. 2022 Feb;11(1):595-605. doi: 10.1007/s40121-021-00562-z. Epub 2021 Nov 14.
PubMed 34775578
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Nebulized Ampion In Adults With Respiratory Distress Secondary to COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04606784
- Acronym / sponsor ID
- AP-014
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ampio Pharmaceuticals. Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 28 Oct 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.
This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of nebulized Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who have respiratory distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ampion | Experimental | Biological: Ampion, Other: Standard of CareAmpion |
| Standard of Care | Other | Other: Standard of CareStandard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, ≥ 18 years old.
- Diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-CoV-2, or suspected COVID-19 diagnosis based on radiological clinical findings.
- Respiratory distress as evidenced by at least two of the following:
- A signed informed consent form from the patient or the patient's legal representative must be available.
Key exclusion criteria (9 listed)
- In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place
- Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
- Patient is on chronic immunosuppressive medication.
- As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
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 |
|---|---|---|
| AmpionAmpion, nebulized for inhalation | Biological | Ampion |
| Standard of CareStandard of Care | Other | Ampion, Standard of Care |
Primary outcome
Incidence and severity of adverse events
Time frame: Day 5
Incidence and severity of adverse events
Incidence and severity of adverse events
Time frame: Day 28
Incidence and severity of adverse events
2 secondary outcomes
Clinical status using 8-point ordinal scale
Time frame: Day 5
Clinical status using 8-point ordinal scale
Time frame: Day 28
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 21 Mar 2022.
- Derived from this study: PubMed 34775578Roshon M, Lemos-Filho L, Cherevka H, Goldberg L, Salottolo K, Bar-Or D. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of a Novel Inhaled Biologic Therapeutic in Adults with Respiratory Distress Secondary to COVID-19 Infection. Infect Dis Ther. 2022 Feb;11(1):595-605. doi: 10.1007/s40121-021-00562-z. Epub 2021 Nov 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ampion in people with Covid19, run by Ampio Pharmaceuticals. Inc. 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 8 inclusion and 9 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 Mar 2022. 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?
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.
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?
Incidence and severity of adverse events (time frame: Day 5). 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 NCT04606784, 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 21 Mar 2022.