BronchiolitisNCT02834819
Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
A study testing 3% Nebulized Hypertonic Saline in people with Bronchiolitis, run by University of Colorado, Denver.
Trial summary
The purpose of this study is to determine whether nebulized 3% hypertonic saline is more effective than the current standard of care in the treatment of viral bronchiolitis in children. Read more about this study
- Who is it for?
- Ages 3 to 18 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- 3% Nebulized Hypertonic Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients presenting to Children's Hospital Colorado ED
- ≥3 to ≤18 months of age
- Diagnosed with bronchiolitis
- Have persistent hypoxia following initial supportive care measures as outlined by Children's Hospital Colorado Bronchiolitis Clinical Care Guideline
- Started on Children's Hospital Colorado Home Oxygen Pathway
Who cannot join
- Patients who do not qualify for the Clinical Care Guideline for Home oxygen for Bronchiolitis
- Previous history of wheezing
- History of reactive airway disease
- History of underlying heart disease
- Require >0.5L oxygen
About this study
Official title: A Randomized Controlled Trial of Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
The purpose of this study is to determine whether nebulized 3% hypertonic saline is more effective than the current standard of care in the treatment of viral bronchiolitis in children.
Read the detailed description
This will be a prospective, randomized controlled single-blinded study of patients 3-18 months of age presenting to the Children's Hospital Colorado ED during bronchiolitis season, diagnosed with mild to moderate bronchiolitis and persistent hypoxia and started on the Children's Hospital Colorado Home Oxygen pathway (see attached clinical care guideline). Investigators aim to enroll 220 patients. Patients will be identified by research assistants in the ED, based on physician diagnosis of bronchiolitis, with hypoxia requiring < 0.5L oxygen by NC. A research assistant will approach the family and go through the informed consent process. If consent is obtained, the patient will then be randomized to one of the two study arms via a computer generated randomization table. In order to arrange for respiratory therapy, the research assistants will not be blinded. There will be an age block randomization scheme, and therefore patients aged 3-12 months will be randomized separately from patients 12.1-18 months to ensure equal distribution of age ranges in each arm.
The experimental arm will consist of patients who receive a nebulized treatment of 4ml of 3% hypertonic saline, administered by a respiratory therapist, as well as supportive care as needed. Patients in the control arm will receive supportive care only, the current standard of care at Children's Hospital Colorado. The pharmacist will randomize patients as noted above. After consent is obtained the provider will perform a pre-intervention clinical severity score evaluation to patients in both study arms utilizing the clinical severity score tool described by Wang et al.19 Respiratory therapy will then provide the nebulized treatment for those patients randomized to receive hypertonic saline. Removal of equipment following treatment will aid in ensuring blinding of physicians to treatment arm. At 90 minutes after treatment with hypertonic saline or after the order is placed for patients in the control arm, patients in both arms will undergo a second clinical severity score by the provider. At that time the provider will turn off the oxygen administered to both treatment arms for a room air challenge. The RN will be notified that the patients are off oxygen therapy and will restart oxygen if patient has saturations < 87% (as indicated by continuous pulse oximetry) and oxygen will be restarted at 0.5L by NC.
Patients in both arms who are no longer requiring oxygen will be observed for a minimum of 4 hours to ensure they remain stable on room air, have appropriate oral intake, and sleep without de-saturation. At any point if a patient who was weaned off oxygen becomes hypoxic (saturations < 87%), requiring < 0.5L oxygen NC they will return to the home oxygen observation protocol. If during this period of observation any patient requires > 0.5L oxygen during wake or sleep periods, is not taking adequate oral intake, demonstrates respiratory distress, or at physician discretion, patient may be admitted to the inpatient service for further management.
Patients in both arms will receive follow-up phone calls to assess duration and amount of oxygen, as well as adverse outcomes. Patients discharged home on room air will receive 1 phone call on post-discharge day #7 (range 6-8). Patients discharged home on oxygen will receive a phone call on day #7 (range 6-8). Calls will be made for the study by the study investigators or by the Emergency Department (ED) research assistants. During the follow-up phone call, caregivers will be asked about Primary Care Physician (PCP) follow-up visits, any future scheduled PCP visits, any adverse events including increased work of breathing, increased oxygen requirement, repeat ED visits to researchers or other institutions, outside hospital admissions, intensive care unit admission or intubations, and any instructions for weaning oxygen given by PCP. If parents have questions or concerns, these questions will be directed to a nurse, fellow, or attending provider.
Data from each subject will be collected on a data collection sheet for the follow-up phone call and PCP call. Data will then be entered into a database on a secure server and de-identified. All identifiers will be removed from the data set.
The Electronic Health Record will be reviewed to verify return visits. If return visits are documented in EPIC (electronic health records software), data on type of admission (general pediatrics or intensive care unit) and any advanced airway intervention such as intubation, continuous positive airway pressure (CPAP).
- Conditions
- Bronchiolitis
- Being tested
- 3% Nebulized Hypertonic Saline
- Keywords
- bronchiolitis, hypoxia, hypertonic saline
- Medical subject headings
- Bronchiolitis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% Nebulized Hypertonic SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic Saline | Experimental | Patients randomized to the hypertonic saline group will be administered one nebulized treatment of 3% hypertonic saline. They will also receive what is considered standard of care, which includes suctioning and supportive care as needed. Receives: Drug: 3% Nebulized Hypertonic Saline |
| No treatment | No intervention | Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization Rate
Effect of nebulized 3% hypertonic saline on hospitalization rate in children with bronchiolitis compared to those who receive the current standard of care
Measured: At any point during enrollment visit or up to 7 days after enrollment visit.
Number of Patients With Persistent Hypoxia
To assess the effect of nebulized hypertonic saline on hypoxia in children with bronchiolitis compared to those who receive current standard of care.
Measured: At baseline and 90 minutes post-intervention
Need for Supplemental Oxygen After Discharge
To assess the effect of nebulized hypertonic saline on supplemental home oxygen requirement in children with bronchiolitis compared to those who receive the current standard of care.
Measured: At time of discharge from the hospital through 7 days.
Secondary outcomes (5)
Pre- Intervention Clinical Severity Score
Clinical severity score taken immediately following randomization, and prior to any intervention to assess change in baseline after intervention and compare change in scores, if any, between the two groups. The Scale utilized was the Clinical Severity Score from Wang et al, which measures respiratory distress in young children. The system assigns scores ranging from 0 to 3 for the following categories: respiratory rate, wheezing, retraction, and general condition. These category scores are then summed to come up with the final Clinical Severity Score. Total scores range from 0 to 12, with higher scores indicating greater severity/worse outcomes.
Measured: During Enrollment visit following randomization.
Post-intervention Clinical Severity Score
Clinical severity score taken at time 90 minutes in both arms to assess any change in clinical severity score from baseline. The Scale utilized was the Clinical Severity Score from Wang et al, which measures respiratory distress in young children. The system assigns scores ranging from 0 to3 for the following categories: respiratory rate, wheezing, retraction, and general condition. These category scores are then summed to come up with the final Clinical Severity Score. Total scores range from 0 to 12, with higher scores indicating greater severity/worse outcomes.
Measured: During enrollment visit - 90 minutes after randomization
Unscheduled Return ED Visits
Unscheduled visit to ED within 3 days of enrollment visit.
Patients in each group will be contacted 7 days after the enrollment visit to see if they had any unscheduled return ED visit within 3 days of the enrollment visit.
Measured: Called at 7 days post enrollment visit to assess any visit within 3 days of enrollment visit
Adverse Outcomes
Respiratory distress, increased oxygen requirement, advanced airway interventions (NIPPV or intubation).
Measured: During enrollment visit or within 7 days following enrollment visit
Hospital Admission After Discharge
Admission to any hospital institution within 7 days following enrollment visit
Measured: Within 7 days following discharge from enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Lack of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cortney Braund, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834819
- Sponsor's protocol ID
- 13-0092
- Status last verified
- Feb 2020
- First submitted
- 1 Apr 2016
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010 Feb;125(2):342-9. doi: 10.1542/peds.2009-2092. Epub 2010 Jan 25.
PubMed 20100768American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.
PubMed 17015575Yorita KL, Holman RC, Sejvar JJ, Steiner CA, Schonberger LB. Infectious disease hospitalizations among infants in the United States. Pediatrics. 2008 Feb;121(2):244-52. doi: 10.1542/peds.2007-1392.
PubMed 18245414Kini NM, Robbins JM, Kirschbaum MS, Frisbee SJ, Kotagal UR; Child Health Accountability Initiative. Inpatient care for uncomplicated bronchiolitis: comparison with Milliman and Robertson guidelines. Arch Pediatr Adolesc Med. 2001 Dec;155(12):1323-7. doi: 10.1001/archpedi.155.12.1323.
PubMed 11732950Pelletier AJ, Mansbach JM, Camargo CA Jr. Direct medical costs of bronchiolitis hospitalizations in the United States. Pediatrics. 2006 Dec;118(6):2418-23. doi: 10.1542/peds.2006-1193.
PubMed 17142527Mallory MD, Shay DK, Garrett J, Bordley WC. Bronchiolitis management preferences and the influence of pulse oximetry and respiratory rate on the decision to admit. Pediatrics. 2003 Jan;111(1):e45-51. doi: 10.1542/peds.111.1.e45.
PubMed 12509594Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2.
PubMed 18843717Mai XM, Nilsson L, Kjellman NI, Bjorksten B. Hypertonic saline challenge tests in the diagnosis of bronchial hyperresponsiveness and asthma in children. Pediatr Allergy Immunol. 2002 Oct;13(5):361-7. doi: 10.1034/j.1399-3038.2002.01011.x.
PubMed 12431196Wark P, McDonald VM. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD001506. doi: 10.1002/14651858.CD001506.pub3.
PubMed 19370568Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.
PubMed 20713480
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
- ClinicalTrials.gov ID
- NCT02834819
- Acronym / sponsor ID
- 13-0092
- Conditions
- Bronchiolitis
- Keywords
- bronchiolitis, hypoxia, hypertonic saline
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of financial support
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Posted 11 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether nebulized 3% hypertonic saline is more effective than the current standard of care in the treatment of viral bronchiolitis in children.
Detailed description
This will be a prospective, randomized controlled single-blinded study of patients 3-18 months of age presenting to the Children's Hospital Colorado ED during bronchiolitis season, diagnosed with mild to moderate bronchiolitis and persistent hypoxia and started on the Children's Hospital Colorado Home Oxygen pathway (see attached clinical care guideline). Investigators aim to enroll 220 patients. Patients will be identified by research assistants in the ED, based on physician diagnosis of bronchiolitis, with hypoxia requiring < 0.5L oxygen by NC. A research assistant will approach the family and go through the informed consent process. If consent is obtained, the patient will then be randomized to one of the two study arms via a computer generated randomization table. In order to arrange for respiratory therapy, the research assistants will not be blinded. There will be an age block randomization scheme, and therefore patients aged 3-12 months will be randomized separately from patients 12.1-18 months to ensure equal distribution of age ranges in each arm.
The experimental arm will consist of patients who receive a nebulized treatment of 4ml of 3% hypertonic saline, administered by a respiratory therapist, as well as supportive care as needed. Patients in the control arm will receive supportive care only, the current standard of care at Children's Hospital Colorado. The pharmacist will randomize patients as noted above. After consent is obtained the provider will perform a pre-intervention clinical severity score evaluation to patients in both study arms utilizing the clinical severity score tool described by Wang et al.19 Respiratory therapy will then provide the nebulized treatment for those patients randomized to receive hypertonic saline. Removal of equipment following treatment will aid in ensuring blinding of physicians to treatment arm. At 90 minutes after treatment with hypertonic saline or after the order is placed for patients in the control arm, patients in both arms will undergo a second clinical severity score by the provider. At that time the provider will turn off the oxygen administered to both treatment arms for a room air challenge. The RN will be notified that the patients are off oxygen therapy and will restart oxygen if patient has saturations < 87% (as indicated by continuous pulse oximetry) and oxygen will be restarted at 0.5L by NC.
Patients in both arms who are no longer requiring oxygen will be observed for a minimum of 4 hours to ensure they remain stable on room air, have appropriate oral intake, and sleep without de-saturation. At any point if a patient who was weaned off oxygen becomes hypoxic (saturations < 87%), requiring < 0.5L oxygen NC they will return to the home oxygen observation protocol. If during this period of observation any patient requires > 0.5L oxygen during wake or sleep periods, is not taking adequate oral intake, demonstrates respiratory distress, or at physician discretion, patient may be admitted to the inpatient service for further management.
Patients in both arms will receive follow-up phone calls to assess duration and amount of oxygen, as well as adverse outcomes. Patients discharged home on room air will receive 1 phone call on post-discharge day #7 (range 6-8). Patients discharged home on oxygen will receive a phone call on day #7 (range 6-8). Calls will be made for the study by the study investigators or by the Emergency Department (ED) research assistants. During the follow-up phone call, caregivers will be asked about Primary Care Physician (PCP) follow-up visits, any future scheduled PCP visits, any adverse events including increased work of breathing, increased oxygen requirement, repeat ED visits to researchers or other institutions, outside hospital admissions, intensive care unit admission or intubations, and any instructions for weaning oxygen given by PCP. If parents have questions or concerns, these questions will be directed to a nurse, fellow, or attending provider.
Data from each subject will be collected on a data collection sheet for the follow-up phone call and PCP call. Data will then be entered into a database on a secure server and de-identified. All identifiers will be removed from the data set.
The Electronic Health Record will be reviewed to verify return visits. If return visits are documented in EPIC (electronic health records software), data on type of admission (general pediatrics or intensive care unit) and any advanced airway intervention such as intubation, continuous positive airway pressure (CPAP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertonic Saline | Experimental | Drug: 3% Nebulized Hypertonic SalinePatients randomized to the hypertonic saline group will be administered one nebulized treatment of 3% hypertonic saline. They will also receive what is considered standard of care, which includes suctioning and supportive care as needed. |
| No treatment | No intervention | –Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed. |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients presenting to Children's Hospital Colorado ED
- ≥3 to ≤18 months of age
- Diagnosed with bronchiolitis
- Have persistent hypoxia following initial supportive care measures as outlined by Children's Hospital Colorado Bronchiolitis Clinical Care Guideline
- Started on Children's Hospital Colorado Home Oxygen Pathway
Key exclusion criteria (5 listed)
- Patients who do not qualify for the Clinical Care Guideline for Home oxygen for Bronchiolitis
- Previous history of wheezing
- History of reactive airway disease
- History of underlying heart disease
- Require >0.5L oxygen
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 |
|---|---|---|
| 3% Nebulized Hypertonic Saline | Drug | Hypertonic Saline |
Primary outcome
Hospitalization Rate
Time frame: At any point during enrollment visit or up to 7 days after enrollment visit.
Effect of nebulized 3% hypertonic saline on hospitalization rate in children with bronchiolitis compared to those who receive the current standard of care
Number of Patients With Persistent Hypoxia
Time frame: At baseline and 90 minutes post-intervention
To assess the effect of nebulized hypertonic saline on hypoxia in children with bronchiolitis compared to those who receive current standard of care.
Need for Supplemental Oxygen After Discharge
Time frame: At time of discharge from the hospital through 7 days.
To assess the effect of nebulized hypertonic saline on supplemental home oxygen requirement in children with bronchiolitis compared to those who receive the current standard of care.
5 secondary outcomes
Pre- Intervention Clinical Severity Score
Time frame: During Enrollment visit following randomization.
Post-intervention Clinical Severity Score
Time frame: During enrollment visit - 90 minutes after randomization
Unscheduled Return ED Visits
Time frame: Called at 7 days post enrollment visit to assess any visit within 3 days of enrollment visit
Adverse Outcomes
Time frame: During enrollment visit or within 7 days following enrollment visit
Hospital Admission After Discharge
Time frame: Within 7 days following discharge from enrollment visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20100768Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010 Feb;125(2):342-9. doi: 10.1542/peds.2009-2092. Epub 2010 Jan 25.
- Background: PubMed 17015575American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.
- Background: PubMed 18245414Yorita KL, Holman RC, Sejvar JJ, Steiner CA, Schonberger LB. Infectious disease hospitalizations among infants in the United States. Pediatrics. 2008 Feb;121(2):244-52. doi: 10.1542/peds.2007-1392.
- Background: PubMed 11732950Kini NM, Robbins JM, Kirschbaum MS, Frisbee SJ, Kotagal UR; Child Health Accountability Initiative. Inpatient care for uncomplicated bronchiolitis: comparison with Milliman and Robertson guidelines. Arch Pediatr Adolesc Med. 2001 Dec;155(12):1323-7. doi: 10.1001/archpedi.155.12.1323.
- Background: PubMed 17142527Pelletier AJ, Mansbach JM, Camargo CA Jr. Direct medical costs of bronchiolitis hospitalizations in the United States. Pediatrics. 2006 Dec;118(6):2418-23. doi: 10.1542/peds.2006-1193.
- Background: PubMed 12509594Mallory MD, Shay DK, Garrett J, Bordley WC. Bronchiolitis management preferences and the influence of pulse oximetry and respiratory rate on the decision to admit. Pediatrics. 2003 Jan;111(1):e45-51. doi: 10.1542/peds.111.1.e45.
- Background: PubMed 18843717Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2.
- Background: PubMed 12431196Mai XM, Nilsson L, Kjellman NI, Bjorksten B. Hypertonic saline challenge tests in the diagnosis of bronchial hyperresponsiveness and asthma in children. Pediatr Allergy Immunol. 2002 Oct;13(5):361-7. doi: 10.1034/j.1399-3038.2002.01011.x.
- Background: PubMed 19370568Wark P, McDonald VM. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD001506. doi: 10.1002/14651858.CD001506.pub3.
- Background: PubMed 20713480Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.
- Individual participant dataSharing planned: Undecided
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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.
Cortney Braund, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing 3% Nebulized Hypertonic Saline in people with Bronchiolitis, run by University of Colorado, Denver.
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: stopped early, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospitalization Rate (time frame: At any point during enrollment visit or up to 7 days after enrollment visit.). 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 NCT02834819, which also lists 10 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 11 Feb 2020.