Covid19
Conditions
Brief 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).
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.
Interventions
BIOLOGICALAmpion
Inhaled Ampion
OTHERPlacebo
Inhaled Placebo
Sponsors
Ampio Pharmaceuticals. Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female adults: ≥ 18 years. 2. 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. 3. 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. 4. Able to bear weight and ambulate a minimum of 10 meters distance. 5. 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. 6. Informed consent obtained from the patient or the patient's legal representative.
Exclusion criteria
1. Subjects who require hospitalization. 2. 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.). 3. History of Chronic Fatigue Syndrome prior to COVID-19 infection. 4. Patient is on chronic immunosuppressive medication. 5. Patient requires surgery that could be life-threatening within the study window. 6. 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). 7. Patient has known pregnancy or is currently breastfeeding. 8. 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). 9. 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. 10. 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) 11. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Ampion
Ampion: Inhaled nebulized Ampion (8 mL) administered four times daily, every four to six hours, for five days. | 16 |
| Control Placebo
Placebo: Inhaled nebulized saline (8 mL) administered four times daily, every four to six hours, for five days. | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incorrectly Randomized followed for Safety | 0 | 1 |
| Overall Study | Lack of Compliance | 1 | 1 |
| Overall Study | Screen Failure | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Active | Control | Total |
|---|---|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 11.9 | 55.1 years STANDARD_DEVIATION 13.7 | 52.1 years STANDARD_DEVIATION 13 |
| Body Mass Index (BMI) | 32.6 kg/m^2 STANDARD_DEVIATION 7.4 | 34.1 kg/m^2 STANDARD_DEVIATION 7 | 33.4 kg/m^2 STANDARD_DEVIATION 7.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 22 Participants |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 18 Participants |
| Sex: Female, Male Male | 9 Participants | 5 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 8 / 15 | 9 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
Primary
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.
Time frame: Baseline to Day 28
Population: Safety Population - one participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Subjects with SAE's | 0 Participants |
| Active | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Subjects with Treatment Emergent Adverse Events (TEAE's) | 5 Participants |
| Active | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Subjects with Study Drug Related TEAE's | 3 Participants |
| Active | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Subjects with Moderate or Severe TEAE's | 1 Participants |
| Control | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Subjects with SAE's | 0 Participants |
| Control | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Subjects with Study Drug Related TEAE's | 5 Participants |
| Control | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Subjects with Moderate or Severe TEAE's | 5 Participants |
| Control | The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo | Subjects with Treatment Emergent Adverse Events (TEAE's) | 9 Participants |