Post-Acute Sequelae of SARS-CoV-2 (PASC) InfectionPhase 2NCT05152849
Efficacy, Safety, Tolerability of AXA1125 in Fatigue After COVID-19 Infection
A Phase 2 study testing AXA1125 in people with Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection, run by Axcella Health, Inc at 1 site in United Kingdom.
Trial summary
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving muscle function (metabolism) following moderate exercise in subjects with fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 as well as the safety and tolerability of AXA1125. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
- What is being tested?
- AXA1125
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Dec 2021to 29 Jun 2022
- Phase
- Phase 2
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing to participate in the study and provide written informed consent
- Male and female adults aged > 18 years and less than 65 years
- Must have had clinically suspected COVID-19 and a positive antibody test or a documented SARS-CoV-2 infection (a positive reverse transcription polymerase chain reaction test) at least 12 weeks prior to Screening
- Must have fatigue-predominant PASC
- Other than PASC, a subject must be in good health without other significant medical or not well controlled medical or psychiatric conditions
Who cannot join
- Other than PASC, have an explanation for fatigue
- Other than PASC, a history or presence of an uncontrolled, clinically significant disease
- Medical history that includes of Non-invasive or invasive ventilatory support for COVID 19, Intensive care unit or other high dependency unit admission for COVID-19, Hospitalization for >1 week for COVID-19 without intubation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of AXA1125 in Subjects With Fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving muscle function (metabolism) following moderate exercise in subjects with fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 as well as the safety and tolerability of AXA1125. Subjects will take one dose of AXA1125 or a placebo twice daily for 28 days.
- Being tested
- AXA1125, Placebo
- Keywords
- Long COVID, Long-haul COVID, Muscle weakness, COVID, PASC, Fatigue, Amino acids, Bioenergetics, Mitochondrial dysfunction, Phosphocreatine recovery, Exertional fatigue, Phospho magnetic resonance spectroscopy, Skeletal muscle
- Medical subject headings
- Infections, Post-Acute COVID-19 Syndrome, Muscle Weakness, Fatigue, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXA1125Drug
AXA1125 administered BID with or without food
PlaceboDrug
Matching Placebo administered BID with or without food
| Study group | Role | What they receive |
|---|---|---|
| AXA1125 33.9g | Experimental | 33.9 g AXA1125 administered orally BID with or without food Receives: Drug: AXA1125 |
| Placebo | Placebo comparator | Matching Placebo administered orally BID with or without food Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at Week 4 in the phosphocreatine (PCr) recovery rate following moderate exercise, as assessed by 31P-magnetic resonance spectroscopy (MRS)
Measured: Baseline to 28 days
Secondary outcomes (9)
Change from baseline in PCr recovery rate as assessed by phosphorus magnetic resonance spectroscopy (31P-MRS)
Measured: Baseline to 28 days
Proportion of subjects with improvement in PCr recovery rate
Measured: Baseline to 28 days
Change from baseline in serum lactate level after a 6-minute walk test
Measured: Baseline to 28 days
Proportion of subjects with serum lactate level ≤3 mmol/L after a 6MWT
Measured: Baseline to 28 days
Proportion of subjects with a decrease in venous serum lactate level from baseline after a 6MWT
Measured: Baseline to 28 days
Change from baseline in distance traveled during a 6MWT
Measured: Baseline to 28 days
Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11
Measured: Baseline to14 days
Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11 before and after a 6MWT
Measured: Baseline to 28 days
Proportion of subjects with an improvement in fatigue score as assessed by CFQ-11 before and after a 6MWT
Measured: Baseline to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start15 Dec 2021
- Primary completion21 Jun 2022
- Study completion29 Jun 2022
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 Post-Acute Sequelae of SARS-CoV-2 (PASC) InfectionStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axcella Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Betty Raman, MBBS DPhil FRACP, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152849
- Sponsor's protocol ID
- AXA1125-201
- Status last verified
- Nov 2021
- First submitted
- 29 Nov 2021
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Finnigan LEM, Cassar MP, Koziel MJ, Pradines J, Lamlum H, Azer K, Kirby D, Montgomery H, Neubauer S, Valkovic L, Raman B. Efficacy and tolerability of an endogenous metabolic modulator (AXA1125) in fatigue-predominant long COVID: a single-centre, double-blind, randomised controlled phase 2a pilot study. EClinicalMedicine. 2023 May;59:101946. doi: 10.1016/j.eclinm.2023.101946. Epub 2023 Apr 14.
PubMed 37223439
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of AXA1125 in Subjects With Fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
- ClinicalTrials.gov ID
- NCT05152849
- Acronym / sponsor ID
- AXA1125-201
- Keywords
- Long COVID, Long-haul COVID, Muscle weakness, COVID, PASC, Fatigue, Amino acids, Bioenergetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Axcella Health, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 10 Dec 2021 (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 study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving muscle function (metabolism) following moderate exercise in subjects with fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 as well as the safety and tolerability of AXA1125. Subjects will take one dose of AXA1125 or a placebo twice daily for 28 days.
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 |
|---|---|---|
| AXA1125 33.9g | Experimental | Drug: AXA112533.9 g AXA1125 administered orally BID with or without food |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo administered orally BID with or without food |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing to participate in the study and provide written informed consent
- Male and female adults aged > 18 years and less than 65 years
- Must have had clinically suspected COVID-19 and a positive antibody test or a documented SARS-CoV-2 infection (a positive reverse transcription polymerase chain reaction test) at least 12 weeks prior to Screening
- Must have fatigue-predominant PASC
- Other than PASC, a subject must be in good health without other significant medical or not well controlled medical or psychiatric conditions
Key exclusion criteria (3 listed)
- Other than PASC, have an explanation for fatigue
- Other than PASC, a history or presence of an uncontrolled, clinically significant disease
- Medical history that includes of Non-invasive or invasive ventilatory support for COVID 19, Intensive care unit or other high dependency unit admission for COVID-19, Hospitalization for >1 week for COVID-19 without intubation
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 |
|---|---|---|
| AXA1125AXA1125 administered BID with or without food | Drug | AXA1125 33.9g |
| PlaceboMatching Placebo administered BID with or without food | Drug | Placebo |
Primary outcome
Change from baseline at Week 4 in the phosphocreatine (PCr) recovery rate following moderate exercise, as assessed by 31P-magnetic resonance spectroscopy (MRS)
Time frame: Baseline to 28 days
9 secondary outcomes
Change from baseline in PCr recovery rate as assessed by phosphorus magnetic resonance spectroscopy (31P-MRS)
Time frame: Baseline to 28 days
Proportion of subjects with improvement in PCr recovery rate
Time frame: Baseline to 28 days
Change from baseline in serum lactate level after a 6-minute walk test
Time frame: Baseline to 28 days
Proportion of subjects with serum lactate level ≤3 mmol/L after a 6MWT
Time frame: Baseline to 28 days
Proportion of subjects with a decrease in venous serum lactate level from baseline after a 6MWT
Time frame: Baseline to 28 days
Change from baseline in distance traveled during a 6MWT
Time frame: Baseline to 28 days
Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11
Time frame: Baseline to14 days
Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11 before and after a 6MWT
Time frame: Baseline to 28 days
Proportion of subjects with an improvement in fatigue score as assessed by CFQ-11 before and after a 6MWT
Time frame: Baseline to 28 days
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 20 Oct 2022.
- Derived from this study: PubMed 37223439Finnigan LEM, Cassar MP, Koziel MJ, Pradines J, Lamlum H, Azer K, Kirby D, Montgomery H, Neubauer S, Valkovic L, Raman B. Efficacy and tolerability of an endogenous metabolic modulator (AXA1125) in fatigue-predominant long COVID: a single-centre, double-blind, randomised controlled phase 2a pilot study. EClinicalMedicine. 2023 May;59:101946. doi: 10.1016/j.eclinm.2023.101946. Epub 2023 Apr 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.
Betty Raman, MBBS DPhil FRACP principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AXA1125 in people with Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection, run by Axcella Health, Inc at 1 site in United Kingdom.
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 5 inclusion and 3 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 20 Oct 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 Kingdom. 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?
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?
Change from baseline at Week 4 in the phosphocreatine (PCr) recovery rate following moderate exercise, as assessed by 31P-magnetic resonance spectroscopy (MRS) (time frame: Baseline to 28 days). 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 NCT05152849, 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 20 Oct 2022.