Non-CovidCELTNCT05465837
Comparison Between Early and Late Tracheostomy in Non-Covid and Covid
An observational study of Non-Covid and COVID-19, run by Sultan Qaboos University at 1 site in Oman.
Trial summary
Tracheostomy is commonly indicated for the patient who is requiring long period of mechanical ventilation. Patient who require mechanical ventilation for >10 days and longer mostly get tracheostomized. Tracheostomy is associated with less complications associated with endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- What is being tested?
- Tracheostomy
- Type of treatment
- Surgery or procedure
- How many people
- 156 participants
- Where
- 1 siteOman
- Study dates
- 25 Feb 2022to 28 Jun 2022
- Phase
- Observational
- 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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Population > 18 years old, admitted to Non-Covid and Covid-19 ICU OF Sultan Qaboos University Hospital, Oman, who got tracheostomized during their stay in ICU
Who may be able to join
- • Adult ICU patients (more than 18 years old) who underwent tracheostomy in ICU.
Who cannot join
- • Tracheostomy performed as part of operative management.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Early and Late Tracheostomy in ICU Patients Including Non-Covid and Covid Patients, an Observational Cohort Study at SQUH
Tracheostomy is commonly indicated for the patient who is requiring long period of mechanical ventilation. Patient who require mechanical ventilation for >10 days and longer mostly get tracheostomized. Tracheostomy is associated with less complications associated with endotracheal intubation. Tracheostomy is a surgical procedure whereby an external artificial opening is made in the trachea. Several techniques are used to perform tracheostomy, including the classical standard surgical procedure completed in a surgical room and the percutaneous method performed at the patient's bedside. Surgical and percutaneous procedures are usually performed by different surgical specialists such as general; thoracic; ear, nose and throat (ENT); or maxillofacial surgeons, but percutaneous procedures are usually but not exclusively performed by surgeons and intensivists.
Early tracheostomy might reduce the length of ICU stay, whereas delaying the tracheostomy might avoid a few. A review of recent studies showed a decrease in the mortality rate in early tracheostomised patients compared with late. Tracheostomy is a routine bedside procedure in ICU with minimal complications.
Read more
Severe acute respiratory syndrome (SARS) and Coronavirus 2 (SARS-CoV-2) started to appear in Oman in early February 2020, resulting in an escalation of new cases within days. In the first weeks of the pandemic, many guidelines from different specialties recommended avoiding early tracheostomy to minimize the risk of infection to clinicians.
Specifically, recommendations for tracheostomy in the current pandemic were rooted in the assumption that maximal infectivity of this novel virus occurred around day 7 to 10 after symptom onset, and performing tracheostomy at that time would endanger maximal risk to those performing it. Hence these factors interfered with the timing of Tracheostomy for Covid patients.
This is an observational cohort study. It will assess patients admitted to ICU at SQUH during the period between January 2020 and December 2021 with Non-Covid and Covid-19 patients. This study will assess the causes and outcomes of early and late tracheostomy in Non-Covid and Covid-19 patients requiring mechanical ventilation. Main outcomes will include mortality rate, ventilation days, and ICU length of stay.
Read the detailed description
Introduction:- Tracheostomy is a common procedure for critically ill patients who require long-term mechanical ventilation (3) and have a low Glasgow coma scale and for chest toileting. Compared with an endotracheal tube, a shorter tracheostomy tube that bypasses the mouth and pharynx can avoid oropharyngeal and laryngeal complications, improve patient comfort and reduce sedative drug use.
Early versus late tracheostomy:
In one study comparing early and late tracheostomy, they included eight RCTs. Results showed moderate quality from seven RCTs and lower mortality rates in the early as compared with the late tracheostomy group. On the other hand, in another study which was a prospective observational study, the results showed that there was no difference in 3-month mortality between early and late tracheostomy.
Covid-19 is a recently emerged disease and has resulted in an increasing number of patients requiring mechanical ventilation and ICU admission. Several recommendations and guidelines have discussed when to perform a tracheostomy in COVID-19 patients, while the timing is varied across the literature. Recommendations from the UK and North America suggested that tracheostomy should be delayed until at least 14 days from endotracheal intubation to clarify prognostic information and for the viral load to sufficiently decline. On the other hand, early tracheostomy may help in early weaning (around 7-10 days))
In this study, we aimed to investigate the differences in outcomes when tracheostomy is done early versus late in covid and non-covid cases.
Aim of the Study:
The aim of the current study is to analyze the outcomes of patients with confirmed SARS-CoV-2 pneumonia who underwent tracheostomies and explore the association between the timing of tracheostomy and the outcomes of these patients and compare them with Non-Covid-19 patients.
. The primary outcomes: Mortality in Covid versus Non-Covid cases The secondary outcomes: Ventilation days and ICU length of stay in Covid versus Non-Covid cases.
Methodology:- This retrospective study will be conducted in Sultan Qaboos University Hospital, Oman. After taking Ethics approval, all patients who undergo tracheostomy in intensive care units (ICUs) at SQUH from January 1, 2020, to December 2021 will be screened. A list of all patients who underwent tracheostomies during the study period will be obtained from the Hospital Information system. Their electronic patient records will be scanned, and data will be obtained.
Study Population:
Inclusions:
- Adult ICU patients (more than 18 years old) who underwent tracheostomy in ICU.
Exclusions:
- Tracheostomy performed as part of operative management.
Study Design and Methods:
Overview: This retrospective, observational cohort study will assess the outcomes of early and late tracheostomy in Non-Covid and Covid patients.
Sample size: All tracheostomized patients during the study period will be included in the study.
Study Method:
Medical records of patients will be reviewed, and data will be collected by investigators. Sociodemographic and clinical data will be collected for all patients, including age, sex, medical history, technique and day of ventilation days, ICU length of stay, and mortality.
Details of the tracheostomy procedure, including timing, type (percutaneous or surgical), and complications, will be noted.
Justification of the current study:
In this study, we intend to analyze the outcomes of early and late tracheostomy in covid and non-covid patients. We hope to find a strategy for choosing an appropriate time for tracheostomy in covid and non-covid patients, which will give better outcomes and help reduce ICU mortality, ventilator days, and length of stay.
ETHICAL Aspects:
The master chart will not carry patient names and even MRN will not be accessible to anyone except the principal investigator. In the end, the study subjects will be given code numbers in the final master chart and their ID will not be revealed to the statistician.
Data Management and Analyses:
Statistical analysis: Normally distributed and non-normally distributed continuous variables will be presented as the mean (SD) and median [IQR], respectively. Categorical variables are presented as numbers (%). Early tracheostomy will be defined as tracheostomy within 10 days of intubation, and late tracheostomy will be defined as tracheostomy after 10 days. All statistical analyses will be performed using the SPSS software system.
- Being tested
- Tracheostomy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TracheostomyProcedure or surgery
Early and Late Tracheostomy (</= 10 days: Early and >10 days: Late)
| Study group | Role | What they receive |
|---|---|---|
| Non covid Tracheostomy Patients | Adult patients (>18 years) who underwent tracheostomy without having the covid-19 infection Receives: Procedure: Tracheostomy | |
| Covid-19 Tracheostomy Patients | Adult patients (>18 years) who underwent tracheostomy had the covid-19 infection Receives: Procedure: Tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality in Covid versus Non-Covid cases
30 and 60 Days mortality
Measured: upto 90 days
Secondary outcomes (2)
Ventilation days
Number of ventilation days
Measured: upto 90 days
ICU length of stay
ICU length of stay total
Measured: upto 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start25 Feb 2022
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Non-CovidStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jyoti Burad, Principal investigator, Sultan Qaboos University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465837
- Sponsor's protocol ID
- MREC#2688
- Acronym
- CELT
- Status last verified
- Jun 2022
- First submitted
- 3 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be deposited to Repository: Mendeley and will be made available after this study is published
Publications
Givi B, Schiff BA, Chinn SB, Clayburgh D, Iyer NG, Jalisi S, Moore MG, Nathan CA, Orloff LA, O'Neill JP, Parker N, Zender C, Morris LGT, Davies L. Safety Recommendations for Evaluation and Surgery of the Head and Neck During the COVID-19 Pandemic. JAMA Otolaryngol Head Neck Surg. 2020 Jun 1;146(6):579-584. doi: 10.1001/jamaoto.2020.0780.
PubMed 32232423He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020 May;26(5):672-675. doi: 10.1038/s41591-020-0869-5. Epub 2020 Apr 15.
PubMed 32296168Scales DC, Ferguson ND. Tracheostomy: it's time to move from art to science. Crit Care Med. 2006 Dec;34(12):3039-40. doi: 10.1097/01.CCM.0000242924.24342.9D. No abstract available.
PubMed 17130697Polok K, Fronczek J, van Heerden PV, Flaatten H, Guidet B, De Lange DW, Fjolner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Artigas A, Pinto BB, Schefold JC, Studzinska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP study group. Association between tracheostomy timing and outcomes for older critically ill COVID-19 patients: prospective observational study in European intensive care units. Br J Anaesth. 2022 Mar;128(3):482-490. doi: 10.1016/j.bja.2021.11.027. Epub 2021 Nov 29.
PubMed 34955167Bosel J, Schiller P, Hook Y, Andes M, Neumann JO, Poli S, Amiri H, Schonenberger S, Peng Z, Unterberg A, Hacke W, Steiner T. Stroke-related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical Care Trial (SETPOINT): a randomized pilot trial. Stroke. 2013 Jan;44(1):21-8. doi: 10.1161/STROKEAHA.112.669895. Epub 2012 Nov 29.
PubMed 23204058Hsu CL, Chen KY, Chang CH, Jerng JS, Yu CJ, Yang PC. Timing of tracheostomy as a determinant of weaning success in critically ill patients: a retrospective study. Crit Care. 2005 Feb;9(1):R46-52. doi: 10.1186/cc3018. Epub 2004 Dec 23.
PubMed 15693966Andriolo BN, Andriolo RB, Saconato H, Atallah AN, Valente O. Early versus late tracheostomy for critically ill patients. Cochrane Database Syst Rev. 2015 Jan 12;1(1):CD007271. doi: 10.1002/14651858.CD007271.pub3.
PubMed 25581416
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Early and Late Tracheostomy in ICU Patients Including Non-Covid and Covid Patients, an Observational Cohort Study at SQUH
- ClinicalTrials.gov ID
- NCT05465837
- Acronym / sponsor ID
- CELT / MREC#2688
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 20 Jul 2022 (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.
Tracheostomy is commonly indicated for the patient who is requiring long period of mechanical ventilation. Patient who require mechanical ventilation for >10 days and longer mostly get tracheostomized. Tracheostomy is associated with less complications associated with endotracheal intubation. Tracheostomy is a surgical procedure whereby an external artificial opening is made in the trachea. Several techniques are used to perform tracheostomy, including the classical standard surgical procedure completed in a surgical room and the percutaneous method performed at the patient's bedside. Surgical and percutaneous procedures are usually performed by different surgical specialists such as general; thoracic; ear, nose and throat (ENT); or maxillofacial surgeons, but percutaneous procedures are usually but not exclusively performed by surgeons and intensivists.
Early tracheostomy might reduce the length of ICU stay, whereas delaying the tracheostomy might avoid a few. A review of recent studies showed a decrease in the mortality rate in early tracheostomised patients compared with late. Tracheostomy is a routine bedside procedure in ICU with minimal complications.
Severe acute respiratory syndrome (SARS) and Coronavirus 2 (SARS-CoV-2) started to appear in Oman in early February 2020, resulting in an escalation of new cases within days. In the first weeks of the pandemic, many guidelines from different specialties recommended avoiding early tracheostomy to minimize the risk of infection to clinicians.
Specifically, recommendations for tracheostomy in the current pandemic were rooted in the assumption that maximal infectivity of this novel virus occurred around day 7 to 10 after symptom onset, and performing tracheostomy at that time would endanger maximal risk to those performing it. Hence these factors interfered with the timing of Tracheostomy for Covid patients.
This is an observational cohort study. It will assess patients admitted to ICU at SQUH during the period between January 2020 and December 2021 with Non-Covid and Covid-19 patients. This study will assess the causes and outcomes of early and late tracheostomy in Non-Covid and Covid-19 patients requiring mechanical ventilation. Main outcomes will include mortality rate, ventilation days, and ICU length of stay.
Detailed description
Introduction:- Tracheostomy is a common procedure for critically ill patients who require long-term mechanical ventilation (3) and have a low Glasgow coma scale and for chest toileting. Compared with an endotracheal tube, a shorter tracheostomy tube that bypasses the mouth and pharynx can avoid oropharyngeal and laryngeal complications, improve patient comfort and reduce sedative drug use.
Early versus late tracheostomy:
In one study comparing early and late tracheostomy, they included eight RCTs. Results showed moderate quality from seven RCTs and lower mortality rates in the early as compared with the late tracheostomy group. On the other hand, in another study which was a prospective observational study, the results showed that there was no difference in 3-month mortality between early and late tracheostomy.
Covid-19 is a recently emerged disease and has resulted in an increasing number of patients requiring mechanical ventilation and ICU admission. Several recommendations and guidelines have discussed when to perform a tracheostomy in COVID-19 patients, while the timing is varied across the literature. Recommendations from the UK and North America suggested that tracheostomy should be delayed until at least 14 days from endotracheal intubation to clarify prognostic information and for the viral load to sufficiently decline. On the other hand, early tracheostomy may help in early weaning (around 7-10 days))
In this study, we aimed to investigate the differences in outcomes when tracheostomy is done early versus late in covid and non-covid cases.
Aim of the Study:
The aim of the current study is to analyze the outcomes of patients with confirmed SARS-CoV-2 pneumonia who underwent tracheostomies and explore the association between the timing of tracheostomy and the outcomes of these patients and compare them with Non-Covid-19 patients.
. The primary outcomes: Mortality in Covid versus Non-Covid cases The secondary outcomes: Ventilation days and ICU length of stay in Covid versus Non-Covid cases.
Methodology:- This retrospective study will be conducted in Sultan Qaboos University Hospital, Oman. After taking Ethics approval, all patients who undergo tracheostomy in intensive care units (ICUs) at SQUH from January 1, 2020, to December 2021 will be screened. A list of all patients who underwent tracheostomies during the study period will be obtained from the Hospital Information system. Their electronic patient records will be scanned, and data will be obtained.
Study Population:
Inclusions:
- Adult ICU patients (more than 18 years old) who underwent tracheostomy in ICU.
Exclusions:
- Tracheostomy performed as part of operative management.
Study Design and Methods:
Overview: This retrospective, observational cohort study will assess the outcomes of early and late tracheostomy in Non-Covid and Covid patients.
Sample size: All tracheostomized patients during the study period will be included in the study.
Study Method:
Medical records of patients will be reviewed, and data will be collected by investigators. Sociodemographic and clinical data will be collected for all patients, including age, sex, medical history, technique and day of ventilation days, ICU length of stay, and mortality.
Details of the tracheostomy procedure, including timing, type (percutaneous or surgical), and complications, will be noted.
Justification of the current study:
In this study, we intend to analyze the outcomes of early and late tracheostomy in covid and non-covid patients. We hope to find a strategy for choosing an appropriate time for tracheostomy in covid and non-covid patients, which will give better outcomes and help reduce ICU mortality, ventilator days, and length of stay.
ETHICAL Aspects:
The master chart will not carry patient names and even MRN will not be accessible to anyone except the principal investigator. In the end, the study subjects will be given code numbers in the final master chart and their ID will not be revealed to the statistician.
Data Management and Analyses:
Statistical analysis: Normally distributed and non-normally distributed continuous variables will be presented as the mean (SD) and median [IQR], respectively. Categorical variables are presented as numbers (%). Early tracheostomy will be defined as tracheostomy within 10 days of intubation, and late tracheostomy will be defined as tracheostomy after 10 days. All statistical analyses will be performed using the SPSS software system.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non covid Tracheostomy Patients | – | Procedure: TracheostomyAdult patients (>18 years) who underwent tracheostomy without having the covid-19 infection |
| Covid-19 Tracheostomy Patients | – | Procedure: TracheostomyAdult patients (>18 years) who underwent tracheostomy had the covid-19 infection |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Population > 18 years old, admitted to Non-Covid and Covid-19 ICU OF Sultan Qaboos University Hospital, Oman, who got tracheostomized during their stay in ICU
Key inclusion criteria (1 listed)
- • Adult ICU patients (more than 18 years old) who underwent tracheostomy in ICU.
Key exclusion criteria (1 listed)
- • Tracheostomy performed as part of operative management.
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 |
|---|---|---|
| TracheostomyEarly and Late Tracheostomy (</= 10 days: Early and >10 days: Late) | Procedure or surgery | Covid-19 Tracheostomy Patients, Non covid Tracheostomy Patients |
Primary outcome
Mortality in Covid versus Non-Covid cases
Time frame: upto 90 days
30 and 60 Days mortality
2 secondary outcomes
Ventilation days
Time frame: upto 90 days
ICU length of stay
Time frame: upto 90 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 Jul 2022.
- Background: PubMed 32232423Givi B, Schiff BA, Chinn SB, Clayburgh D, Iyer NG, Jalisi S, Moore MG, Nathan CA, Orloff LA, O'Neill JP, Parker N, Zender C, Morris LGT, Davies L. Safety Recommendations for Evaluation and Surgery of the Head and Neck During the COVID-19 Pandemic. JAMA Otolaryngol Head Neck Surg. 2020 Jun 1;146(6):579-584. doi: 10.1001/jamaoto.2020.0780.
- Background: PubMed 32296168He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020 May;26(5):672-675. doi: 10.1038/s41591-020-0869-5. Epub 2020 Apr 15.
- Background: PubMed 17130697Scales DC, Ferguson ND. Tracheostomy: it's time to move from art to science. Crit Care Med. 2006 Dec;34(12):3039-40. doi: 10.1097/01.CCM.0000242924.24342.9D. No abstract available.
- Background: PubMed 34955167Polok K, Fronczek J, van Heerden PV, Flaatten H, Guidet B, De Lange DW, Fjolner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Artigas A, Pinto BB, Schefold JC, Studzinska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP study group. Association between tracheostomy timing and outcomes for older critically ill COVID-19 patients: prospective observational study in European intensive care units. Br J Anaesth. 2022 Mar;128(3):482-490. doi: 10.1016/j.bja.2021.11.027. Epub 2021 Nov 29.
- Background: PubMed 23204058Bosel J, Schiller P, Hook Y, Andes M, Neumann JO, Poli S, Amiri H, Schonenberger S, Peng Z, Unterberg A, Hacke W, Steiner T. Stroke-related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical Care Trial (SETPOINT): a randomized pilot trial. Stroke. 2013 Jan;44(1):21-8. doi: 10.1161/STROKEAHA.112.669895. Epub 2012 Nov 29.
- Background: PubMed 15693966Hsu CL, Chen KY, Chang CH, Jerng JS, Yu CJ, Yang PC. Timing of tracheostomy as a determinant of weaning success in critically ill patients: a retrospective study. Crit Care. 2005 Feb;9(1):R46-52. doi: 10.1186/cc3018. Epub 2004 Dec 23.
- Results publication: PubMed 25581416Andriolo BN, Andriolo RB, Saconato H, Atallah AN, Valente O. Early versus late tracheostomy for critically ill patients. Cochrane Database Syst Rev. 2015 Jan 12;1(1):CD007271. doi: 10.1002/14651858.CD007271.pub3.
- Individual participant dataSharing planned: Yes. The IPD will be deposited to Repository: Mendeley and will be made available after this study is published
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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.
Jyoti Burad principal investigator
Sultan Qaboos University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Covid and COVID-19, run by Sultan Qaboos University at 1 site in Oman.
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 1 inclusion and 1 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 Jul 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 Oman. 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?
Mortality in Covid versus Non-Covid cases (time frame: upto 90 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 NCT05465837, which also lists 7 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 20 Jul 2022.