Covid19COVASPNCT04896866

Efficacy and Safety of Antimicrobial Stewardship Intervention in Hospitalized COVID-19 Patients (COVASP)

A study testing Antimicrobial stewardship prospective audit and feedback in people with Covid19 and COVID-19 Pneumonia, run by University of Alberta at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19, COVID-19 Pneumonia, COVID-19 Lower Respiratory Infection
What is being tested?: Antimicrobial stewardship prospective audit and feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 833 participants
Where: 3 sitesCanada
Study dates: 1 Mar 2021to 30 Nov 2021
Phase: Interventional
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

Age ≥18 years at the time of hospital admission.
Confirmed SARS-CoV-2 infection by nucleic acid testing in the preceding 14 days of hospital admission.
Admitted from the community (including continuing care facilities).
Admitted to a hospital bed designated in the study.
SpO2 ≤94% requiring supplemental oxygen or chest imaging findings compatible with COVID-19 pneumonia.

Who cannot join

The patient is enrolled in another clinical trial that involves antibacterial therapy.
The patient's goals of care is anticipated to be designated "total compassionate care" or palliative care within 48 hours of admission.
The patient's progression to death is anticipated to be imminent and inevitable within 48 hours of admission.
The patient was attended by any member of the research team within 30 days of enrollment.
The patient is transferred from another acute care center.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

Misericordia Community Hospital
Edmonton, Alberta, T5R 4H5
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8

Other trials in Canada

About this study

Official title: Efficacy and Safety of Antimicrobial Stewardship Intervention in Hospitalized COVID-19 Patients: A Pragmatic Clinical Trial

COVID-19 is respiratory disease caused by the severe acute respiratory coronavirus 2 (SARS-CoV-2), a novel coronavirus which has spread rapidly across the world with over 149.9 million laboratory confirmed cases and over 3.1 million reported deaths since December 2019. Approximately 4-8% of hospitalized patients with COVID-19 have co-infection with bacterial pathogens however there is widespread and often broad-spectrum antibiotic use in these patients.

This is a prospective, multi-center, non-inferiority pragmatic clinical trial of antimicrobial stewardship prospective audit and feedback versus no antimicrobial stewardship intervention on physicians attending to patients with proven SARS-CoV-2 infection confirmed by nucleic acid testing in the preceding 2 weeks of hospitalization for acute COVID-19 pneumonia. Prospective audit and feedback is the real time review of antibacterial prescriptions and immediate feedback to prescribers to optimize antimicrobial prescriptions. Hospital beds will be stratified by COVID unit and critical care unit beds, and will be computer randomized in a 1:1 fashion into 2 arms (antimicrobial stewardship intervention versus no antimicrobial stewardship intervention) prior to study commencement at the participating site. Patients hospitalized to study-eligible beds will be followed for primary and secondary outcomes.

The objective of this study is to determine the effect of an antimicrobial stewardship intervention (prospective audit and feedback) on clinical outcomes in patients hospitalized with acute COVID-19.

Conditions: Covid19, COVID-19 Pneumonia, COVID-19 Lower Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome, SARS-CoV2 Infection, SARS-CoV-2 Acute Respiratory Disease
Being tested: Antimicrobial stewardship prospective audit and feedback
Keywords: antimicrobial stewardship, antibiotic stewardship, prospective audit and feedback, quality improvement, antibiotics
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Antimicrobial stewardship prospective audit and feedbackBehavioural
Audits are performed on weekdays, less statutory holidays, by members of the antimicrobial stewardship team consisting of infectious disease or antimicrobial stewardship physicians or pharmacists. Verbal and written feedback will be provided in real-time. Initial prospective audit and feedback (PAF) will occur on the day of enrolment. Follow-up PAF will occur weekly (+/-3 days to account for weekends or statuary holidays) and ad-hoc if a new antibacterial is prescribed, until the primary end-point. Appropriateness will be assessed based on local clinical practice guidelines. Only antibacterials will be audited. Prescriptions will be excluded from PAF if they are single doses or discontinued prior to PAF. Prescriptions will be also be excluded from PAF and the final analysis if being used for surgical or medical prophylaxis.

Study groups in NCT04896866
Study group	Role	What they receive
Antimicrobial stewardship	Experimental	Antimicrobial stewardship prospective audit and feedback on physicians attending to patients admitted with community-acquired COVID-19 pneumonia to beds randomized to antimicrobial stewardship intervention. Receives: Behavioral: Antimicrobial stewardship prospective audit and feedback
No antimicrobial stewardship	No intervention	No antimicrobial stewardship prospective audit and feedback.

What is being measured

The primary outcome is the main question the study is designed to answer.

Ordinal scale
A 7 point ordinal scale of clinical outcomes:
1. point - Not hospitalized, able to resume normal daily activities
2. points - Not hospitalized, unable to resume normal daily activities
3. points - Hospitalized, not on supplemental oxygen
4. points - Hospitalized, on supplemental oxygen
5. points - Hospitalized, on high flow oxygen therapy or non-invasive mechanical ventilation
6. points - Hospitalized, on ECMO or invasive mechanical ventilation
7. points - Death
Higher scores means a worse outcome.
Measured: Day 15 of hospital admission

Secondary outcomes (14)

Length of hospital stay
Duration of hospitalization in days
Measured: through study completion, an average of 5 days
In-hospital mortality
Death occurring during hospital admission
Measured: through study completion, an average of 5 days
30-day mortality
Mortality in the first 30 days after diagnosis
Measured: 30 days
30-day C. difficile associated mortality
Death related to C. difficile-associated diarrhea in the first 30 days after diagnosis
Measured: 30 days
30 day re-admission rate
Re-admission to hospital after initial discharge in the first 30 days after diagnosis
Measured: 30 days from hospital discharge
Days of therapy normalized for patient-days
Days of antibiotic therapy normalized for patients-day
Measured: capped at 30 days of hospitalization
Length of total antimicrobial therapy normalized for patient-days
Length of antibiotics normalized for patient-days
Measured: capped at 30 days of hospitalization
Number of antimicrobial stewardship audits
Number of audits by ASP
Measured: through study completion, an average of 5 days
Number of antimicrobial stewardship recommendations
Number of recommendations by ASP
Measured: through study completion, an average of 5 days
Antimicrobial stewardship acceptance rates
Acceptance rate of ASP recommendations
Measured: through study completion, an average of 5 days
Multi-drug resistant bacteria infection rates
Development of multi-drug resistant bacterial infection in the first 30 days after diagnosis
Measured: 30 days
Clostridioides difficile infection rate
1. difficile-associated diarrhea in the first 30 days after diagnosis
Measured: 30 days
Percentage of participants with neutropenia
Occurrence of neutropenia in the first 30 days
Measured: 30 days
Acute kidney injury
diagnosed and staged as according to KDIGO
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202130 Nov 2021

First posted21 May 2021
Study start1 Mar 2021
Primary completion15 Oct 2021
Study completion30 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)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 AlbertaThe 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 N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Hospital beds are randomized prior to enrolment to intervention versus observation. Intervention consists of antimicrobial stewardship prospective audit and feedback.
Masking: None (open label)
Enrolment: 833 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04896866
Sponsor's protocol ID: Pro00105598
Acronym: COVASP
Status last verified: Apr 2023
First submitted: 17 May 2021
Last updated: 19 Sep 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The study protocol will be published in an open journal.

Publications

MacIntyre CR, Chughtai AA, Barnes M, Ridda I, Seale H, Toms R, Heywood A. The role of pneumonia and secondary bacterial infection in fatal and serious outcomes of pandemic influenza a(H1N1)pdm09. BMC Infect Dis. 2018 Dec 7;18(1):637. doi: 10.1186/s12879-018-3548-0.
PubMed 30526505
Shah NS, Greenberg JA, McNulty MC, Gregg KS, Riddell J 4th, Mangino JE, Weber DM, Hebert CL, Marzec NS, Barron MA, Chaparro-Rojas F, Restrepo A, Hemmige V, Prasidthrathsint K, Cobb S, Herwaldt L, Raabe V, Cannavino CR, Hines AG, Bares SH, Antiporta PB, Scardina T, Patel U, Reid G, Mohazabnia P, Kachhdiya S, Le BM, Park CJ, Ostrowsky B, Robicsek A, Smith BA, Schied J, Bhatti MM, Mayer S, Sikka M, Murphy-Aguilu I, Patwari P, Abeles SR, Torriani FJ, Abbas Z, Toya S, Doktor K, Chakrabarti A, Doblecki-Lewis S, Looney DJ, David MZ. Bacterial and viral co-infections complicating severe influenza: Incidence and impact among 507 U.S. patients, 2013-14. J Clin Virol. 2016 Jul;80:12-9. doi: 10.1016/j.jcv.2016.04.008. Epub 2016 Apr 14.
PubMed 27130980
Rawson TM, Moore LSP, Zhu N, Ranganathan N, Skolimowska K, Gilchrist M, Satta G, Cooke G, Holmes A. Bacterial and Fungal Coinfection in Individuals With Coronavirus: A Rapid Review To Support COVID-19 Antimicrobial Prescribing. Clin Infect Dis. 2020 Dec 3;71(9):2459-2468. doi: 10.1093/cid/ciaa530.
PubMed 32358954
Langford BJ, So M, Raybardhan S, Leung V, Westwood D, MacFadden DR, Soucy JR, Daneman N. Bacterial co-infection and secondary infection in patients with COVID-19: a living rapid review and meta-analysis. Clin Microbiol Infect. 2020 Dec;26(12):1622-1629. doi: 10.1016/j.cmi.2020.07.016. Epub 2020 Jul 22.
PubMed 32711058
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143
Feng Y, Ling Y, Bai T, Xie Y, Huang J, Li J, Xiong W, Yang D, Chen R, Lu F, Lu Y, Liu X, Chen Y, Li X, Li Y, Summah HD, Lin H, Yan J, Zhou M, Lu H, Qu J. COVID-19 with Different Severities: A Multicenter Study of Clinical Features. Am J Respir Crit Care Med. 2020 Jun 1;201(11):1380-1388. doi: 10.1164/rccm.202002-0445OC.
PubMed 32275452
Wan S, Xiang Y, Fang W, Zheng Y, Li B, Hu Y, Lang C, Huang D, Sun Q, Xiong Y, Huang X, Lv J, Luo Y, Shen L, Yang H, Huang G, Yang R. Clinical features and treatment of COVID-19 patients in northeast Chongqing. J Med Virol. 2020 Jul;92(7):797-806. doi: 10.1002/jmv.25783. Epub 2020 Apr 1.
PubMed 32198776
Wang Z, Yang B, Li Q, Wen L, Zhang R. Clinical Features of 69 Cases With Coronavirus Disease 2019 in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):769-777. doi: 10.1093/cid/ciaa272.
PubMed 32176772
Zhao XY, Xu XX, Yin HS, Hu QM, Xiong T, Tang YY, Yang AY, Yu BP, Huang ZP. Clinical characteristics of patients with 2019 coronavirus disease in a non-Wuhan area of Hubei Province, China: a retrospective study. BMC Infect Dis. 2020 Apr 29;20(1):311. doi: 10.1186/s12879-020-05010-w.
PubMed 32345226
Cao J, Hu X, Cheng W, Yu L, Tu WJ, Liu Q. Clinical features and short-term outcomes of 18 patients with corona virus disease 2019 in intensive care unit. Intensive Care Med. 2020 May;46(5):851-853. doi: 10.1007/s00134-020-05987-7. Epub 2020 Mar 2. No abstract available.
PubMed 32123993
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264
Barrasa H, Rello J, Tejada S, Martin A, Balziskueta G, Vinuesa C, Fernandez-Miret B, Villagra A, Vallejo A, San Sebastian A, Cabanes S, Iribarren S, Fonseca F, Maynar J; Alava COVID-19 Study Investigators. SARS-CoV-2 in Spanish Intensive Care Units: Early experience with 15-day survival in Vitoria. Anaesth Crit Care Pain Med. 2020 Oct;39(5):553-561. doi: 10.1016/j.accpm.2020.04.001. Epub 2020 Apr 9.
PubMed 32278670
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570
Du Y, Tu L, Zhu P, Mu M, Wang R, Yang P, Wang X, Hu C, Ping R, Hu P, Li T, Cao F, Chang C, Hu Q, Jin Y, Xu G. Clinical Features of 85 Fatal Cases of COVID-19 from Wuhan. A Retrospective Observational Study. Am J Respir Crit Care Med. 2020 Jun 1;201(11):1372-1379. doi: 10.1164/rccm.202003-0543OC.
PubMed 32242738
Polgreen PM, Chen YY, Cavanaugh JE, Ward M, Coffman S, Hornick DB, Diekema DJ, Herwaldt LA. An outbreak of severe Clostridium difficile-associated disease possibly related to inappropriate antimicrobial therapy for community-acquired pneumonia. Infect Control Hosp Epidemiol. 2007 Feb;28(2):212-4. doi: 10.1086/512174. Epub 2007 Jan 25.
PubMed 17265406

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Antimicrobial Stewardship Intervention in Hospitalized COVID-19 Patients: A Pragmatic Clinical Trial
ClinicalTrials.gov ID: NCT04896866
Acronym / sponsor ID: COVASP / Pro00105598
Conditions: Covid19, COVID-19 Pneumonia, COVID-19 Lower Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome, SARS-CoV2 Infection, SARS-CoV-2 Acute Respiratory Disease
Keywords: antimicrobial stewardship, antibiotic stewardship, prospective audit and feedback, quality improvement, antibiotics
Study type: Interventional
Recruitment status: Completed
Enrolment: 833 participants (actual)
Lead sponsor: University of AlbertaUniversity, hospital or other
Study start: 1 Mar 2021 (actual)
Primary completion: 15 Oct 2021 (actual)
Study completion: 30 Nov 2021 (actual)
First posted: 21 May 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.

The objective of this study is to determine the effect of an antimicrobial stewardship intervention (prospective audit and feedback) on clinical outcomes in patients hospitalized with acute COVID-19.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Hospital beds are randomized prior to enrolment to intervention versus observation. Intervention consists of antimicrobial stewardship prospective audit and feedback.

Arm	Type	Receives
Antimicrobial stewardship	Experimental	Behavioral: Antimicrobial stewardship prospective audit and feedbackAntimicrobial stewardship prospective audit and feedback on physicians attending to patients admitted with community-acquired COVID-19 pneumonia to beds randomized to antimicrobial stewardship intervention.
No antimicrobial stewardship	No intervention	–No antimicrobial stewardship prospective audit and feedback.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥18 years at the time of hospital admission.
Confirmed SARS-CoV-2 infection by nucleic acid testing in the preceding 14 days of hospital admission.
Admitted from the community (including continuing care facilities).
Admitted to a hospital bed designated in the study.
SpO2 ≤94% requiring supplemental oxygen or chest imaging findings compatible with COVID-19 pneumonia.

Key exclusion criteria (5 listed)

The patient is enrolled in another clinical trial that involves antibacterial therapy.
The patient's goals of care is anticipated to be designated "total compassionate care" or palliative care within 48 hours of admission.
The patient's progression to death is anticipated to be imminent and inevitable within 48 hours of admission.
The patient was attended by any member of the research team within 30 days of enrollment.
The patient is transferred from another acute care center.

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
Antimicrobial stewardship prospective audit and feedbackAudits are performed on weekdays, less statutory holidays, by members of the antimicrobial stewardship team consisting of infectious disease or antimicrobial stewardship physicians or pharmacists. Verbal and written feedback will be provided in real-time. Initial prospective audit and feedback (PAF) will occur on the day of enrolment. Follow-up PAF will occur weekly (+/-3 days to account for weekends or statuary holidays) and ad-hoc if a new antibacterial is prescribed, until the primary end-point. Appropriateness will be assessed based on local clinical practice guidelines. Only antibacterials will be audited. Prescriptions will be excluded from PAF if they are single doses or discontinued prior to PAF. Prescriptions will be also be excluded from PAF and the final analysis if being used for surgical or medical prophylaxis.	Behavioural	Antimicrobial stewardship

Primary outcome

Ordinal scale
Time frame: Day 15 of hospital admission
A 7 point ordinal scale of clinical outcomes: 1. point - Not hospitalized, able to resume normal daily activities 2. points - Not hospitalized, unable to resume normal daily activities 3. points - Hospitalized, not on supplemental oxygen 4. points - Hospitalized, on supplemental oxygen 5. points - Hospitalized, on high flow oxygen therapy or non-invasive mechanical ventilation 6. points - Hospitalized, on ECMO or invasive mechanical ventilation 7. points - Death Higher scores means a worse outcome.

14 secondary outcomes

Length of hospital stay
Time frame: through study completion, an average of 5 days
In-hospital mortality
Time frame: through study completion, an average of 5 days
30-day mortality
Time frame: 30 days
30-day C. difficile associated mortality
Time frame: 30 days
30 day re-admission rate
Time frame: 30 days from hospital discharge
Days of therapy normalized for patient-days
Time frame: capped at 30 days of hospitalization
Length of total antimicrobial therapy normalized for patient-days
Time frame: capped at 30 days of hospitalization
Number of antimicrobial stewardship audits
Time frame: through study completion, an average of 5 days
Number of antimicrobial stewardship recommendations
Time frame: through study completion, an average of 5 days
Antimicrobial stewardship acceptance rates
Time frame: through study completion, an average of 5 days
Multi-drug resistant bacteria infection rates
Time frame: 30 days
Clostridioides difficile infection rate
Time frame: 30 days
Percentage of participants with neutropenia
Time frame: 30 days
Acute kidney injury
Time frame: 30 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 19 Sep 2024.
Background: PubMed 30526505MacIntyre CR, Chughtai AA, Barnes M, Ridda I, Seale H, Toms R, Heywood A. The role of pneumonia and secondary bacterial infection in fatal and serious outcomes of pandemic influenza a(H1N1)pdm09. BMC Infect Dis. 2018 Dec 7;18(1):637. doi: 10.1186/s12879-018-3548-0.
Background: PubMed 27130980Shah NS, Greenberg JA, McNulty MC, Gregg KS, Riddell J 4th, Mangino JE, Weber DM, Hebert CL, Marzec NS, Barron MA, Chaparro-Rojas F, Restrepo A, Hemmige V, Prasidthrathsint K, Cobb S, Herwaldt L, Raabe V, Cannavino CR, Hines AG, Bares SH, Antiporta PB, Scardina T, Patel U, Reid G, Mohazabnia P, Kachhdiya S, Le BM, Park CJ, Ostrowsky B, Robicsek A, Smith BA, Schied J, Bhatti MM, Mayer S, Sikka M, Murphy-Aguilu I, Patwari P, Abeles SR, Torriani FJ, Abbas Z, Toya S, Doktor K, Chakrabarti A, Doblecki-Lewis S, Looney DJ, David MZ. Bacterial and viral co-infections complicating severe influenza: Incidence and impact among 507 U.S. patients, 2013-14. J Clin Virol. 2016 Jul;80:12-9. doi: 10.1016/j.jcv.2016.04.008. Epub 2016 Apr 14.
Background: PubMed 32358954Rawson TM, Moore LSP, Zhu N, Ranganathan N, Skolimowska K, Gilchrist M, Satta G, Cooke G, Holmes A. Bacterial and Fungal Coinfection in Individuals With Coronavirus: A Rapid Review To Support COVID-19 Antimicrobial Prescribing. Clin Infect Dis. 2020 Dec 3;71(9):2459-2468. doi: 10.1093/cid/ciaa530.
Background: PubMed 32711058Langford BJ, So M, Raybardhan S, Leung V, Westwood D, MacFadden DR, Soucy JR, Daneman N. Bacterial co-infection and secondary infection in patients with COVID-19: a living rapid review and meta-analysis. Clin Microbiol Infect. 2020 Dec;26(12):1622-1629. doi: 10.1016/j.cmi.2020.07.016. Epub 2020 Jul 22.
Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
Background: PubMed 32275452Feng Y, Ling Y, Bai T, Xie Y, Huang J, Li J, Xiong W, Yang D, Chen R, Lu F, Lu Y, Liu X, Chen Y, Li X, Li Y, Summah HD, Lin H, Yan J, Zhou M, Lu H, Qu J. COVID-19 with Different Severities: A Multicenter Study of Clinical Features. Am J Respir Crit Care Med. 2020 Jun 1;201(11):1380-1388. doi: 10.1164/rccm.202002-0445OC.
Background: PubMed 32198776Wan S, Xiang Y, Fang W, Zheng Y, Li B, Hu Y, Lang C, Huang D, Sun Q, Xiong Y, Huang X, Lv J, Luo Y, Shen L, Yang H, Huang G, Yang R. Clinical features and treatment of COVID-19 patients in northeast Chongqing. J Med Virol. 2020 Jul;92(7):797-806. doi: 10.1002/jmv.25783. Epub 2020 Apr 1.
Background: PubMed 32176772Wang Z, Yang B, Li Q, Wen L, Zhang R. Clinical Features of 69 Cases With Coronavirus Disease 2019 in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):769-777. doi: 10.1093/cid/ciaa272.
Background: PubMed 32345226Zhao XY, Xu XX, Yin HS, Hu QM, Xiong T, Tang YY, Yang AY, Yu BP, Huang ZP. Clinical characteristics of patients with 2019 coronavirus disease in a non-Wuhan area of Hubei Province, China: a retrospective study. BMC Infect Dis. 2020 Apr 29;20(1):311. doi: 10.1186/s12879-020-05010-w.
Background: PubMed 32123993Cao J, Hu X, Cheng W, Yu L, Tu WJ, Liu Q. Clinical features and short-term outcomes of 18 patients with corona virus disease 2019 in intensive care unit. Intensive Care Med. 2020 May;46(5):851-853. doi: 10.1007/s00134-020-05987-7. Epub 2020 Mar 2. No abstract available.
Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
Background: PubMed 32278670Barrasa H, Rello J, Tejada S, Martin A, Balziskueta G, Vinuesa C, Fernandez-Miret B, Villagra A, Vallejo A, San Sebastian A, Cabanes S, Iribarren S, Fonseca F, Maynar J; Alava COVID-19 Study Investigators. SARS-CoV-2 in Spanish Intensive Care Units: Early experience with 15-day survival in Vitoria. Anaesth Crit Care Pain Med. 2020 Oct;39(5):553-561. doi: 10.1016/j.accpm.2020.04.001. Epub 2020 Apr 9.
Individual participant dataSharing planned: Yes. The study protocol will be published in an open journal.

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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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Antimicrobial stewardship prospective audit and feedback in people with Covid19 and COVID-19 Pneumonia, run by University of Alberta at 3 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 5 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

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?

Ordinal scale (time frame: Day 15 of hospital admission). 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 NCT04896866, which also lists 21 linked publications.

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 Sep 2024.