Coronavirus InfectionPhase 2AX-COVIDNCT04748757
Annexin A5 in Patients With Severe COVID-19 Disease
A Phase 2 study testing recombinant human annexin A5 in people with Coronavirus Infection and Sepsis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Randomized, double-blind, placebo-controlled trial comparing 2 doses of SY-005 (recombinant human Annexin A5) to placebo in patients with severe coronavirus 2019 disease in a single hospital centre with 2 intensive care units Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronavirus Infection, Sepsis
- What is being tested?
- recombinant human annexin A5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2021to 1 Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years
- Positive test for SARS-CoV-2 virus (anytime during current illness episode)
- Admitted to intensive care for organ failure support (at least one of vasopressor, non-invasive or invasive ventilation)
Who cannot join
- Known allergy to any of the ingredients or components of the investigational product
- Known pregnancy
- Moribund and not expected to survive beyond 24 hours
- Known or suspected risk for serious bleeding complications (note that Disseminated Intravascular Coagulopathy (DIC) is an expected finding in patient with sepsis and COVID-19 disease and is not an exclusion criterion on its own)
- Acute or chronic renal failure (dialysis dependent)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Annexin A5 in Patients With Severe COVID-19 Disease: A Single Centre, Randomized, Double-blind, Placebo-controlled Pilot Trial
Randomized, double-blind, placebo-controlled trial comparing 2 doses of SY-005 (recombinant human Annexin A5) to placebo in patients with severe coronavirus 2019 disease in a single hospital centre with 2 intensive care units
- Conditions
- Coronavirus Infection, Sepsis
- Being tested
- recombinant human annexin A5, Placebo
- Medical subject headings
- Coronavirus Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human annexin A5Drug
Also called SY-005
recombinant human annexin A5, manufactured as SY-005
PlaceboDrug
Normal saline 50 ml
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Normal saline, 50 ml infusion over 30 minutes every 12 hours for 7 days Receives: Drug: Placebo |
| Low dose | Experimental | 50 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days Receives: Drug: recombinant human annexin A5 |
| High dose | Experimental | 100 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days Receives: Drug: recombinant human annexin A5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Participants enrolled per site per month with success defined as enrollment >= 50% of screened eligible patients
Measured: 12 months
Protocol adherence
Delivery of investigational product within 1 hour of scheduled dose; success defined as >= 90%
Measured: 7 days
Data completeness
Case Report Forms completed with <10% missing data after verification and monitoring
Measured: 12 months
Secondary outcomes (17)
Organ failure
Sequential Organ Failure Assessment (SOFA) at 30 days; range 0 (normal) to 24
Measured: 30 days
Organ function at end of treatment measured with SOFA
SOFA at end of treatment (EOT)
Measured: 7 days
Organ function at end of treatment measured with Multiple Organ Dysfunction Score (MODS)
MODS at end of treatment (EOT); range 0 (normal) to 24
Measured: 7 days
Individual organ function scores at EOT measured with SOFA
SOFA for individual organ systems
Measured: 30 days
Individual organ function scores at 30 days measured with SOFA
SOFA for individual organ systems
Measured: 30 days
Individual organ function scores at EOT measured with MODS
MODS for individual organ systems
Measured: 30 days
Individual organ function scores at 30 days measured with MODS
MODS for individual organ systems
Measured: 30 days
Plasma annexin A5 levels daily days 1-8 (treatment period) and on day 14
Annexin A5 will be measured daily during treatment and on day 14
Measured: 14 days
Mortality at 60 days
All cause mortality
Measured: 60 days
Hospital mortality
Hospital mortality censored at 60 days
Measured: 60 days
Ventilator-free days
Days alive and off ventilator at 30 days
Measured: 30 days
ICU-free days
Days alive and not in ICU at 30 days
Measured: 30 days
Number of participants with persistent organ dysfunction
MODS score greater or equal to 2 in any organ system at day 30
Measured: 30 days
Number of serious adverse events (SAE)
SAE
Measured: 60 days
Maximum plasma concentration (Cmax) of annexin A5 (SY-005)
Pharmacokinetic profile on day 1
Measured: 1 day
Elimination half-life of annexin A5 (SY-005)
Pharmacokinetic profile on day 1
Measured: 1 day
Number of participants with anti-annexin A5 antibodies
Anti-annexin A5 antibodies
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start20 Apr 2021
- Primary completion3 Apr 2022
- Study completion1 Dec 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 Coronavirus InfectionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Colleges and Universities, London Health Sciences Foundation
- Responsible party
- Sponsor
- Investigators
- Claudio Martin, MD, MSc, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748757
- Sponsor's protocol ID
- REDA-10122
- Acronym
- AX-COVID
- Status last verified
- Mar 2023
- First submitted
- 2 Feb 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information and data sharing will be considered on individual basis at conclusion of the study.
Publications
Tschirhart BJ, Lu X, Mokale Kognou AL, Martin CM, Slessarev M, Fraser DD, Leligdowicz A, Urquhart B, Feng Q. Pharmacokinetics of recombinant human annexin A5 (SY-005) in patients with severe COVID-19. Front Pharmacol. 2024 Jan 10;14:1299613. doi: 10.3389/fphar.2023.1299613. eCollection 2023.
PubMed 38269269
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Annexin A5 in Patients With Severe COVID-19 Disease: A Single Centre, Randomized, Double-blind, Placebo-controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT04748757
- Acronym / sponsor ID
- AX-COVID / REDA-10122
- Conditions
- Coronavirus Infection, Sepsis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Ontario Ministry of Colleges and Universities, London Health Sciences Foundation
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 3 Apr 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 10 Feb 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.
Randomized, double-blind, placebo-controlled trial comparing 2 doses of SY-005 (recombinant human Annexin A5) to placebo in patients with severe coronavirus 2019 disease in a single hospital centre with 2 intensive care units
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboNormal saline, 50 ml infusion over 30 minutes every 12 hours for 7 days |
| Low dose | Experimental | Drug: recombinant human annexin A550 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days |
| High dose | Experimental | Drug: recombinant human annexin A5100 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 19 years
- Positive test for SARS-CoV-2 virus (anytime during current illness episode)
- Admitted to intensive care for organ failure support (at least one of vasopressor, non-invasive or invasive ventilation)
Key exclusion criteria (5 listed)
- Known allergy to any of the ingredients or components of the investigational product
- Known pregnancy
- Moribund and not expected to survive beyond 24 hours
- Known or suspected risk for serious bleeding complications (note that Disseminated Intravascular Coagulopathy (DIC) is an expected finding in patient with sepsis and COVID-19 disease and is not an exclusion criterion on its own)
- Acute or chronic renal failure (dialysis dependent)
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 |
|---|---|---|
| recombinant human annexin A5Also: SY-005recombinant human annexin A5, manufactured as SY-005 | Drug | High dose, Low dose |
| PlaceboNormal saline 50 ml | Drug | Placebo |
Primary outcome
Enrollment
Time frame: 12 months
Participants enrolled per site per month with success defined as enrollment >= 50% of screened eligible patients
Protocol adherence
Time frame: 7 days
Delivery of investigational product within 1 hour of scheduled dose; success defined as >= 90%
Data completeness
Time frame: 12 months
Case Report Forms completed with <10% missing data after verification and monitoring
17 secondary outcomes
Organ failure
Time frame: 30 days
Organ function at end of treatment measured with SOFA
Time frame: 7 days
Organ function at end of treatment measured with Multiple Organ Dysfunction Score (MODS)
Time frame: 7 days
Individual organ function scores at EOT measured with SOFA
Time frame: 30 days
Individual organ function scores at 30 days measured with SOFA
Time frame: 30 days
Individual organ function scores at EOT measured with MODS
Time frame: 30 days
Individual organ function scores at 30 days measured with MODS
Time frame: 30 days
Plasma annexin A5 levels daily days 1-8 (treatment period) and on day 14
Time frame: 14 days
Mortality at 60 days
Time frame: 60 days
Hospital mortality
Time frame: 60 days
Ventilator-free days
Time frame: 30 days
ICU-free days
Time frame: 30 days
Number of participants with persistent organ dysfunction
Time frame: 30 days
Number of serious adverse events (SAE)
Time frame: 60 days
Maximum plasma concentration (Cmax) of annexin A5 (SY-005)
Time frame: 1 day
Elimination half-life of annexin A5 (SY-005)
Time frame: 1 day
Number of participants with anti-annexin A5 antibodies
Time frame: 21 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 8 Mar 2023.
- Derived from this study: PubMed 38269269Tschirhart BJ, Lu X, Mokale Kognou AL, Martin CM, Slessarev M, Fraser DD, Leligdowicz A, Urquhart B, Feng Q. Pharmacokinetics of recombinant human annexin A5 (SY-005) in patients with severe COVID-19. Front Pharmacol. 2024 Jan 10;14:1299613. doi: 10.3389/fphar.2023.1299613. eCollection 2023.
- Individual participant dataSharing planned: Yes. Information and data sharing will be considered on individual basis at conclusion of the study.
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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.
Claudio Martin, MD, MSc principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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 recombinant human annexin A5 in people with Coronavirus Infection and Sepsis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 inclusion and 5 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 8 Mar 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 Canada. 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?
Enrollment (time frame: 12 months). The study lists 3 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 NCT04748757, 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 8 Mar 2023.