COVID-19Phase 2NCT04880109
A Phase 2 Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19.
A Phase 2 study testing APX-115 in people with COVID-19, run by Aptabio Therapeutics, Inc. at 6 sites in United States.
Trial summary
This phase 2 study is to assess the safety and tolerability of APX-115 active doses compared to placebo following multiple oral dosing in hospitalized patients with confirmed, mild to moderate, symptomatic COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- APX-115
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Oct 2021to 28 Apr 2022
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent themselves or through their legally authorized representative.
- Male or female patients, of any race or ethnicity, 18 to 80 years of age, inclusive, on the day of informed consent. Racial and ethnic minorities should be included in the study population to the greatest extent possible.
- Laboratory-confirmed SARS-CoV-2 infection as determined within 14 days of randomization by real time RT-PCR or other commercial or public health assay authorized by FDA or other applicable health authority .
- Onset of COVID-19 symptoms within 14 days prior to randomization.
- Have at least one of the following symptoms at screening: fever, cough, shortness of breath, myalgia, ageusia, anosmia, fatigue, or weakness.
- Hospitalized with COVID-19 disease (WHO COVID-19 Clinical Improvement Ordinal Scale score of 3 [hospitalized, no oxygen therapy], 4 [hospitalized, oxygen by mask or nasal prongs], or 5 [high-flow oxygen or non-invasive mechanical ventilation])
- Patient is aware of the investigational nature of this study and willing to comply with protocol treatments, blood tests, and other evaluations listed in the informed consent form.
Who cannot join
- Females who are pregnant (negative pregnancy test required for all women of childbearing potential at screening) or breastfeeding.
- Male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as postmenopausal for >12 months) who are not using at least one protocol specified method of contraception.
- COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal Scale, scores of 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation).
- Expected survival less than 72 hours.
- Treatment with other drugs thought to possibly have activity against SARS CoV 2 infection within 7 days or within 5 half-lives, whichever is longer, prior to enrollment or concurrently. Drugs that have received FDA emergency use authorization or COVID-19 approval are allowed.
- Treatment with immunosuppressants, combination of 2 or more RAS blockers, UGT inhibitors and inducers, herbal/natural supplements, potassium-sparing diuretic, and radiographic contrast agent prior to enrollment or concurrently.
Show all 19Show fewer
- History of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the investigator.
- Use of any other concurrent investigational drugs while participating in the present study.
- Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (eg, for organ transplantation or autoimmune conditions).
- Known renal disease with an estimated glomerular filtration rate <30 mL/min.
- Patients with clinically apparent liver disease (eg, jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis) or moderate or severe hepatic impairment as determined by Child-Pugh score Class B or C.
- Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) >3 × upper limit of normal (ULN) AND total bilirubin levels >2 × ULN OR ALT or AST >5 × ULN.
- Total bilirubin >1.5 × ULN, unless the patient has known Gilbert's syndrome.
- Hemoglobin <9 g/dL for females or <11 g/dL for males.
- Absolute neutrophil count <1500/mm3.
- Thrombocytopenia (platelets count <100 × 109/L).
- Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (eg, Crohn's disease) or malabsorption at screening.
- Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.
- History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Anne Arundel Medical Center
Annapolis, Maryland, 21401
TriHealth Bethesda North Hospital
Cincinnati, Ohio, 45242
Medical City Fort Worth
Fort Worth, Texas, 76104
FCCP; Jamaica Hospital Medical Center
Jamaica, New York, 11418
FASN, FAHA; John L. McClellan Memorial Veterans Hospital
Little Rock, Arkansas, 72205
MSc, FAAN; Metro Health Hospital - Professional Building
Wyoming, Michigan, 49519
About this study
Official title: A Phase 2, Double-blind, Placebo-controlled, Efficacy, and Safety Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19.
This phase 2 study is to assess the safety and tolerability of APX-115 active doses compared to placebo following multiple oral dosing in hospitalized patients with confirmed, mild to moderate, symptomatic COVID-19. It is anticipated that approximately 80 patients will be randomized into the study in a 1:1 ratio to 100 mg APX-115 or placebo arm.
Read the detailed description
APX-115 is a potent small molecule inhibitor of NADPH-oxidase (Nox) isozymes being developed by Aptabio Therapeutics Inc. The Nox enzymes represent a family of 7 membrane enzymes (Nox1, Nox2, Nox3, Nox4, Nox5, Duox1, and Duox2) which catalyze NADPH-dependent generation of superoxide and secondary reactive oxygen species (ROS).
ROS are often generated during virus infection, thus promoting apoptosis, lung injury, and inflammation/allergy.
- Conditions
- COVID-19
- Being tested
- APX-115, Placebo
- Keywords
- Pulmonary fibrosis, COVID-19, SARS-COV-2, ROS
- Medical subject headings
- COVID-19, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APX-115Drug
Oral administration of APX-115 100 mg capsule once daily for 14 days
PlaceboDrug
Oral administration of placebo capsule once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| APX-115 | Experimental | Oral administration of APX-115 100mg, daily for 14 days Receives: Drug: APX-115 |
| Placebo | Placebo comparator | Oral administration of Placebo, daily for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Adverse events will be assessed to evaluate the safety and tolerability of APX-115 in mild-to-moderate COVID-19 patients. Clinical laboratory evaluations, vital signs, and ECG will be used to assess adverse events.
Measured: over the 60-day period
Secondary outcomes (3)
Time to Clinical Recovery
Recovery is defined as when WHO Clinical Improvement Ordinal Scale equal to or less than 3.
WHO Clinical Improvement Ordinal Scale
Uninfected :
-No clinical or virological evidence of infection 0
Ambulatory:
- No limitation of activities 1
- Limitation of activities 2
Hospitalized Mild disease:
- Hospitalized, no oxygen therapy 3
- Oxygen by mask or nasal prongs 4
Hospitalized Severe Disease:
- Non-invasive ventilation or high-flow oxygen 5
- Intubation and mechanical ventilation 6
- Ventilation + additional organ support - pressors, RRT, ECMO 7
Dead :
- Death 8
Measured: Up to 29 Days
Time to Discharge
WHO Clinical Improvement Ordinal Scale is equal to or less than 2. WHO Clinical Improvement Ordinal Scale
Uninfected :
-No clinical or virological evidence of infection 0
Ambulatory:
- No limitation of activities 1
- Limitation of activities 2
Hospitalized Mild disease:
- Hospitalized, no oxygen therapy 3
- Oxygen by mask or nasal prongs 4
Hospitalized Severe Disease:
- Non-invasive ventilation or high-flow oxygen 5
- Intubation and mechanical ventilation 6
- Ventilation + additional organ support - pressors, RRT, ECMO 7
Dead :
- Death 8
Measured: Up to Day 29
Proportion of Patients in Clinical Recovery
Symptom Assessment of patients in clinical recovery
Measured: up to 29 days
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 start20 Oct 2021
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Why it stopped: Enrollment Challenges
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 COVID-19Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptabio Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880109
- Sponsor's protocol ID
- A01-115-03
- Status last verified
- Jan 2024
- First submitted
- 29 Apr 2021
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Placebo-controlled, Efficacy, and Safety Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19.
- ClinicalTrials.gov ID
- NCT04880109
- Acronym / sponsor ID
- A01-115-03
- Conditions
- COVID-19
- Keywords
- Pulmonary fibrosis, COVID-19, SARS-COV-2, ROS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment Challenges
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Aptabio Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Posted 10 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2 study is to assess the safety and tolerability of APX-115 active doses compared to placebo following multiple oral dosing in hospitalized patients with confirmed, mild to moderate, symptomatic COVID-19. It is anticipated that approximately 80 patients will be randomized into the study in a 1:1 ratio to 100 mg APX-115 or placebo arm.
Detailed description
APX-115 is a potent small molecule inhibitor of NADPH-oxidase (Nox) isozymes being developed by Aptabio Therapeutics Inc. The Nox enzymes represent a family of 7 membrane enzymes (Nox1, Nox2, Nox3, Nox4, Nox5, Duox1, and Duox2) which catalyze NADPH-dependent generation of superoxide and secondary reactive oxygen species (ROS).
ROS are often generated during virus infection, thus promoting apoptosis, lung injury, and inflammation/allergy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APX-115 | Experimental | Drug: APX-115Oral administration of APX-115 100mg, daily for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboOral administration of Placebo, daily for 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to provide informed consent themselves or through their legally authorized representative.
- Male or female patients, of any race or ethnicity, 18 to 80 years of age, inclusive, on the day of informed consent. Racial and ethnic minorities should be included in the study population to the greatest extent possible.
- Laboratory-confirmed SARS-CoV-2 infection as determined within 14 days of randomization by real time RT-PCR or other commercial or public health assay authorized by FDA or other applicable health authority .
- Onset of COVID-19 symptoms within 14 days prior to randomization.
- Have at least one of the following symptoms at screening: fever, cough, shortness of breath, myalgia, ageusia, anosmia, fatigue, or weakness.
Key exclusion criteria (19 listed)
- Females who are pregnant (negative pregnancy test required for all women of childbearing potential at screening) or breastfeeding.
- Male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as postmenopausal for >12 months) who are not using at least one protocol specified method of contraception.
- COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal Scale, scores of 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation).
- Expected survival less than 72 hours.
- Treatment with other drugs thought to possibly have activity against SARS CoV 2 infection within 7 days or within 5 half-lives, whichever is longer, prior to enrollment or concurrently. Drugs that have received FDA emergency use authorization or COVID-19 approval are allowed.
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 |
|---|---|---|
| APX-115Oral administration of APX-115 100 mg capsule once daily for 14 days | Drug | APX-115 |
| PlaceboOral administration of placebo capsule once daily for 14 days | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: over the 60-day period
Adverse events will be assessed to evaluate the safety and tolerability of APX-115 in mild-to-moderate COVID-19 patients. Clinical laboratory evaluations, vital signs, and ECG will be used to assess adverse events.
3 secondary outcomes
Time to Clinical Recovery
Time frame: Up to 29 Days
Time to Discharge
Time frame: Up to Day 29
Proportion of Patients in Clinical Recovery
Time frame: up to 29 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APX-115 in people with COVID-19, run by Aptabio Therapeutics, Inc. at 6 sites 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 7 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: stopped early, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 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 10 Jun 2026). 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?
Incidence of Treatment-Emergent Adverse Events (time frame: over the 60-day period). 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 10 Jun 2026.