Covid19Phase 1NCT04880161
A Study to Evaluate Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID)
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 I study to evaluate the safety and efficacy of inhaled Ampion on patients with prolonged respiratory symptoms due to COVID-19 (Long COVID). 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?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2021to 21 Feb 2022
- Phase
- Phase 1
- 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
- Male or female adults: ≥ 18 years.
- Must have a clinical diagnosis of COVID-19 at least 4 weeks prior to the screening date, with at least one of clinical symptoms (e.g., fever ≥ 38°C, fatigue, cough) and a positive result by the reverse-transcription polymerase chain reaction (RT-PCR) testing or equivalent.
- Experiencing at least two COVID-19 respiratory symptoms with a score of two or higher using the FDA Assessment of 14 Common COVID-19-Related Symptoms questionnaire for at least 4 weeks (28 days) after initial positive COVID-19 diagnosis: cough, sore throat, runny/stuffy nose, shortness of breath (difficulties breathing), tightness of chest, low exercise tolerance.
- Able to bear weight and ambulate a minimum of 10 meters distance.
- Women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study.
- Informed consent obtained from the patient or the patient's legal representative.
Who cannot join
- Subjects who require hospitalization.
- Patient has severe chronic obstructive or restrictive pulmonary disease (COPD) as defined by prior pulmonary function tests, chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.).
- History of Chronic Fatigue Syndrome prior to COVID-19 infection.
- Patient is on chronic immunosuppressive medication.
- Patient requires surgery that could be life-threatening within the study window.
- A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (N-acetyl tryptophan, sodium caprylate).
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- Patient has known pregnancy or is currently breastfeeding.
- Participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).
- Clinically significant findings via electrocardiogram (ECG), including acute myocardial infarction, acute ischemic changes, atrial fibrillation, atrial flutter, paced rhythms in individuals who have undergone permanent pacemaker placement, evidence of prior infarction, unchanged stable conduction abnormalities e.g., right bundle branch block, or any other finding which does not significantly impact mortality.
- Pre-existing co-morbid condition(s) preventing outcome assessments, e.g. disease or condition that would prevent ability to transfer and walk for 6 minutes, prior to confirmed COVID-19 diagnosis (assisted walking devices are acceptable)
- As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety and Efficacy of Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID)
This is a phase I study to evaluate the safety and efficacy of inhaled Ampion on patients with prolonged respiratory symptoms due to COVID-19 (Long COVID).
Read the detailed description
Increasing numbers of people with COVID-19 are experiencing the lingering effects of COVID-19 and continue to have prolonged respiratory complications months after the onset of the disease, also known as Post-Acute Sequelae of SARS-CoV-2 (PASC), long-COVID, and/or long-hauler patients.
The SARS-CoV-2 virus is transmitted through the respiratory system, which can cause a severe dysregulation of the immune response and damage in the lungs. Chronic, prolonged inflammation of the lungs maybe responsible for a myriad of continuing respiratory signs and symptoms post-infection, including cough, shortness of breath, chest discomfort, low exercise tolerance and low blood oxygen saturation.
Ampion is the low molecular weight filtrate of human serum albumin with the in vitro ability to modulate inflammatory cytokine levels. Ampion has the potential to improve clinical outcomes for long-COVID patients.
This study aims to evaluate the safety of Ampion and the clinical outcomes in patients with long-COVID.
- Conditions
- Covid19
- Being tested
- Ampion, Placebo
- 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
Inhaled Ampion
PlaceboOther
Inhaled Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Ampion Receives: Biological: Ampion |
| Control | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo
Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of inhalation Ampion compared to Placebo. AEs were assessed based on symptoms as a severity rating of mild, moderate, or severe. The relationship between AE and study drug was determined as either unrelated, possibly related, or related. SAEs are defined as resulting death, life threatening, requires prolonged hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start26 Jul 2021
- Primary completion22 Dec 2021
- Study completion21 Feb 2022
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT04880161
- Sponsor's protocol ID
- AP-018
- Status last verified
- May 2022
- First submitted
- 6 May 2021
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety and Efficacy of Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID)
- ClinicalTrials.gov ID
- NCT04880161
- Acronym / sponsor ID
- AP-018
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ampio Pharmaceuticals. Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Posted 21 Sep 2023
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 I study to evaluate the safety and efficacy of inhaled Ampion on patients with prolonged respiratory symptoms due to COVID-19 (Long COVID).
Detailed description
Increasing numbers of people with COVID-19 are experiencing the lingering effects of COVID-19 and continue to have prolonged respiratory complications months after the onset of the disease, also known as Post-Acute Sequelae of SARS-CoV-2 (PASC), long-COVID, and/or long-hauler patients.
The SARS-CoV-2 virus is transmitted through the respiratory system, which can cause a severe dysregulation of the immune response and damage in the lungs. Chronic, prolonged inflammation of the lungs maybe responsible for a myriad of continuing respiratory signs and symptoms post-infection, including cough, shortness of breath, chest discomfort, low exercise tolerance and low blood oxygen saturation.
Ampion is the low molecular weight filtrate of human serum albumin with the in vitro ability to modulate inflammatory cytokine levels. Ampion has the potential to improve clinical outcomes for long-COVID patients.
This study aims to evaluate the safety of Ampion and the clinical outcomes in patients with long-COVID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Biological: AmpionAmpion |
| Control | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female adults: ≥ 18 years.
- Must have a clinical diagnosis of COVID-19 at least 4 weeks prior to the screening date, with at least one of clinical symptoms (e.g., fever ≥ 38°C, fatigue, cough) and a positive result by the reverse-transcription polymerase chain reaction (RT-PCR) testing or equivalent.
- Experiencing at least two COVID-19 respiratory symptoms with a score of two or higher using the FDA Assessment of 14 Common COVID-19-Related Symptoms questionnaire for at least 4 weeks (28 days) after initial positive COVID-19 diagnosis: cough, sore throat, runny/stuffy nose, shortness of breath (difficulties breathing), tightness of chest, low exercise tolerance.
- Able to bear weight and ambulate a minimum of 10 meters distance.
- Women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study.
Key exclusion criteria (11 listed)
- Subjects who require hospitalization.
- Patient has severe chronic obstructive or restrictive pulmonary disease (COPD) as defined by prior pulmonary function tests, chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.).
- History of Chronic Fatigue Syndrome prior to COVID-19 infection.
- Patient is on chronic immunosuppressive medication.
- Patient requires surgery that could be life-threatening within the study window.
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 |
|---|---|---|
| AmpionInhaled Ampion | Biological | Active |
| PlaceboInhaled Placebo | Other | Control |
Primary outcome
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo
Time frame: Baseline to Day 28
Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of inhalation Ampion compared to Placebo. AEs were assessed based on symptoms as a severity rating of mild, moderate, or severe. The relationship between AE and study drug was determined as either unrelated, possibly related, or related. SAEs are defined as resulting death, life threatening, requires prolonged hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 6 inclusion and 11 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 Sep 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Sep 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?
The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo (time frame: Baseline to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2023.