Covid19Phase 4CATCO-NOSNCT04748588
Treatment of Nosocomial COVID-19
A Phase 4 study testing Anti-SARS-CoV-2 mAb in people with Covid19 and Nosocomial Infection, run by University of Calgary at 4 sites in Canada.
Trial summary
COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. Nosocomial acquisition of SARS-CoV-2 is a frequent concern across hospital settings in Canada and is associated with substantial morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Nosocomial Infection, SARS-CoV2 Infection
- What is being tested?
- Anti-SARS-CoV-2 mAb
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesCanada
- Study dates
- 12 Feb 2021to 31 Jan 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay, in any specimen prior to randomization.
- Admitted to a participating centre
- Is nosocomially acquired infection, as defined by ALL of:
- COVID19 diagnosis being made on admission day three or later;
- Admitted for a reason other than COVID19;
- Within 5 days of COVID19 diagnosis based on test collection date or initial development of symptoms, which ever was earliest.
Who cannot join
- Plan for palliation within 24 hours
- Known allergy to study medication or its components (non-medicinal ingredients)
- Ordinal scale 6 or above
- Admitted to facility for non-medical reasons including primary psychiatric diagnosis or labour and delivery.
- Pregnancy or breast feeding
- Weight less than 40kg
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
University of Calgary
Calgary, Alberta, T2N1N4
University of Alberta
Edmonton, Alberta, T6G 2B7
Hôpital Montfort
Ottawa, Ontario, K1K0T2
Michael Garron Hospital
Toronto, Ontario, M4C3E7
About this study
Official title: Canadian Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of Nosocomial Acquired COVID-19 Patients
COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. Nosocomial acquisition of SARS-CoV-2 is a frequent concern across hospital settings in Canada and is associated with substantial morbidity and mortality. This clinical trial is initially designed to evaluate the role of monoclonal antibodies against the SARS-CoV-2 spike protein, for the treatment of hospitalized patients who acquire COVID19 via nosocomial infection. New treatments, as they become available, may be integrated, with appropriate adaptation of this document. The trial was initiated with the bamlanivimab product with the options of casirivimab/imdesimab and sotrovimab added as the prevalence of bamlanivimab resistant variants of concerns increased.
It is believed that monoclonal antibody treatments are most likely to be effective early in the disease course. The ability to rapidly identify and initiate such treatments in patients with nosocomial acquisition of the infection, combined with the high mortality of 25-30% experienced by this group of patients led us to propose this trial in collaboration with the CATCO national network.
Read more
The overall objective of the study is to evaluate the safety and clinical effectiveness of anti-SARS-CoV-2 monoclonal antibody treatment relative to the control arm, in patients who develop nosocomial SARS-CoV-2 infection, on need for mechanical ventilation or death.
This study is designed as a pragmatic randomized, open-label, controlled clinical trial.
Subjects will be randomized to receive either standard-of-care (control) or the study medication on a 1:2 basis. Bamlanivimab, casirivimab/imdesimab or sotrovimab will be administered intravenously as a one-time infusion after randomization. Casirivimab/imdesimab (REGN) and sotrovimab will be the default agents based on local availability unless both are unavailable AND virus strain known to be native or alpha (B.1.1.7). Incidence of infusion-related reactions in the 24 hours post administration.
- Conditions
- Covid19, Nosocomial Infection, SARS-CoV2 Infection
- Being tested
- Anti-SARS-CoV-2 mAb
- Keywords
- bamlanivimab, casirivimab, imdesimab, sotrovimab
- Medical subject headings
- COVID-19, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-SARS-CoV-2 mAbDrug
Also called casirivimab/imdesimab, bamlanivimab, sotrovimab
Casirivimab/imdesimab 1200mg/1200mg OR sotrovimab 500mg OR bamlanivimab 700mg IV x1.
Casirivimab/imdesimab (REGN) and sotrovimab will be the default agents used (according to local availability) unless both unavailable AND virus strain known to be native or alpha (B.1.1.7) in which case bamlanivimab can be used.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Not described |
| Anti SARS-CoV-2 monoclonal antibody | Experimental | Single IV administration of an anti-SARS-CoV-2 Monoclonal antibody Receives: Drug: Anti-SARS-CoV-2 mAb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants requiring mechanical ventilation or not surviving to hospital discharge
Measured: Length of hospitalization or 60 days
Secondary outcomes (4)
In-hospital death
Measured: 60 days
Need for mechanical ventilation
Measured: 60 days
Need for new intensive care admission
Measured: 60 days
Need for new oxygen administration
Measured: 60 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 start12 Feb 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Why it stopped: Equipoise requirement no longer met.
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 Covid19Studies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Responsible party
- Sponsor
- Investigators
- Alain Tremblay, Principal investigator, University of CalgaryRobert Fowler, Principal investigator, University of TorontoSrinivas Murthy, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748588
- Sponsor's protocol ID
- REB21-0096
- Acronym
- CATCO-NOS
- Status last verified
- Jan 2021
- First submitted
- 8 Feb 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of Nosocomial Acquired COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04748588
- Acronym / sponsor ID
- CATCO-NOS / REB21-0096
- Conditions
- Covid19, Nosocomial Infection, SARS-CoV2 Infection
- Keywords
- bamlanivimab, casirivimab, imdesimab, sotrovimab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Equipoise requirement no longer met.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 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.
COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. Nosocomial acquisition of SARS-CoV-2 is a frequent concern across hospital settings in Canada and is associated with substantial morbidity and mortality. This clinical trial is initially designed to evaluate the role of monoclonal antibodies against the SARS-CoV-2 spike protein, for the treatment of hospitalized patients who acquire COVID19 via nosocomial infection. New treatments, as they become available, may be integrated, with appropriate adaptation of this document. The trial was initiated with the bamlanivimab product with the options of casirivimab/imdesimab and sotrovimab added as the prevalence of bamlanivimab resistant variants of concerns increased.
It is believed that monoclonal antibody treatments are most likely to be effective early in the disease course. The ability to rapidly identify and initiate such treatments in patients with nosocomial acquisition of the infection, combined with the high mortality of 25-30% experienced by this group of patients led us to propose this trial in collaboration with the CATCO national network.
The overall objective of the study is to evaluate the safety and clinical effectiveness of anti-SARS-CoV-2 monoclonal antibody treatment relative to the control arm, in patients who develop nosocomial SARS-CoV-2 infection, on need for mechanical ventilation or death.
This study is designed as a pragmatic randomized, open-label, controlled clinical trial.
Subjects will be randomized to receive either standard-of-care (control) or the study medication on a 1:2 basis. Bamlanivimab, casirivimab/imdesimab or sotrovimab will be administered intravenously as a one-time infusion after randomization. Casirivimab/imdesimab (REGN) and sotrovimab will be the default agents based on local availability unless both are unavailable AND virus strain known to be native or alpha (B.1.1.7). Incidence of infusion-related reactions in the 24 hours post administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | – |
| Anti SARS-CoV-2 monoclonal antibody | Experimental | Drug: Anti-SARS-CoV-2 mAbSingle IV administration of an anti-SARS-CoV-2 Monoclonal antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay, in any specimen prior to randomization.
- Admitted to a participating centre
- Is nosocomially acquired infection, as defined by ALL of:
- COVID19 diagnosis being made on admission day three or later;
Key exclusion criteria (6 listed)
- Plan for palliation within 24 hours
- Known allergy to study medication or its components (non-medicinal ingredients)
- Ordinal scale 6 or above
- Admitted to facility for non-medical reasons including primary psychiatric diagnosis or labour and delivery.
- Pregnancy or breast feeding
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 |
|---|---|---|
| Anti-SARS-CoV-2 mAbAlso: casirivimab/imdesimab, bamlanivimab, sotrovimabCasirivimab/imdesimab 1200mg/1200mg OR sotrovimab 500mg OR bamlanivimab 700mg IV x1. Casirivimab/imdesimab (REGN) and sotrovimab will be the default agents used (according to local availability) unless both unavailable AND virus strain known to be native or alpha (B.1.1.7) in which case bamlanivimab can be used. | Drug | Anti SARS-CoV-2 monoclonal antibody |
Primary outcome
Proportion of participants requiring mechanical ventilation or not surviving to hospital discharge
Time frame: Length of hospitalization or 60 days
4 secondary outcomes
In-hospital death
Time frame: 60 days
Need for mechanical ventilation
Time frame: 60 days
Need for new intensive care admission
Time frame: 60 days
Need for new oxygen administration
Time frame: 60 days
Results and safety
The study was stopped early (reason given: Equipoise requirement no longer met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- Individual participant dataSharing planned: No
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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.
Alain Tremblay principal investigator
University of Calgary
Robert Fowler principal investigator
University of Toronto
Srinivas Murthy principal investigator
University of British Columbia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anti-SARS-CoV-2 mAb in people with Covid19 and Nosocomial Infection, run by University of Calgary at 4 sites 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 7 inclusion and 6 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Equipoise requirement no longer met.). Results are not available in the source record.
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?
Proportion of participants requiring mechanical ventilation or not surviving to hospital discharge (time frame: Length of hospitalization or 60 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 NCT04748588, 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 19 Apr 2023.