Idiopathic Pulmonary FibrosisPhase 3CleanUp-IPFNCT02759120
CleanUP IPF for the Pulmonary Trials Cooperative
A Phase 3 study testing Antimicrobial therapy: Co-trimoxazole or Doxycycline in people with Idiopathic Pulmonary Fibrosis, run by Weill Medical College of Cornell University at 31 sites in United States.
Trial summary
The purpose of this study is to compare the effect of standard care, versus standard of care plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients diagnosed with idiopathic pulmonary fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Antimicrobial therapy: Co-trimoxazole or Doxycycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 513 participants
- Where
- 31 sitesUnited States
- Study dates
- 22 Mar 2017to 16 Mar 2020
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 40 years of age
- Diagnosed with idiopathic pulmonary fibrosis (IPF) by enrolling investigator
- Signed informed consent
Who cannot join
- Received antimicrobial therapy in the past 30 days
- Contraindicated for antibiotic therapy, including but not exclusive to:
- Allergy or intolerance to both tetracyclines AND trimethoprim, sulfonamides or their combination
- Allergy or intolerance to tetracyclines AND known potassium level > 5 mEq/L in the past 90 days.
- If the enrolling physician feels the potassium level has normalized, documentation to that effect must be provided.
- Allergy or intolerance to tetracyclines AND concomitant use of angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), potassium sparing diuretic, dofetilide, methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide
Show all 13Show fewer
- Allergy or intolerance to tetracyclines AND known glucose-6-phosphate dehydrogenase deficiency
- Allergy or intolerance to tetracyclines AND untreated folate or B12 deficiency
- Allergy or intolerance to tetracyclines AND known renal insufficiency (defined as a glomerular filtration rate (GFR) < 30 ml within the previous 90 days)
- If the enrolling physician feels the renal dysfunction has resolved, documentation to that effect must be provided.
- Pregnant or anticipate becoming pregnant
- Use of an investigational study agent for IPF therapy within the past 30 days, or an IV infusion with a half-life of four (4) weeks.
- Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Albany Medical College
Albany, New York, 12208
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22908
Loyola University Chicago
Chicago, Illinois, 60153
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State
Columbus, Ohio, 43221
INOVA
Falls Church, Virginia, 22042
Spectrum Health
Grand Rapids, Michigan, 49503
Pennsylvania State University
Hershey, Pennsylvania, 17033
University of Kansas
Kansas City, Kansas, 66160
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt
Nashville, Tennessee, 37232
Columbia University
New York, New York, 10032
Weill Cornell Medicine
New York, New York, 10065
Temple University
Philadelphia, Pennsylvania, 19122
University of Rochester
Rochester, New York, 14642
Mayo Clinic
Rochester, New York, 55905
University of California Davis Medical Center
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84108
University of Texas at San Antonio
San Antonio, Texas, 78229
Washington University
Seattle, Washington, 98195
Stanford
Stanford, California, 94305
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis
The purpose of this study is to compare the effect of standard care, versus standard of care plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients diagnosed with idiopathic pulmonary fibrosis (IPF).
Read the detailed description
This is a randomized, un-blinded, phase III, multi-center clinical trial of an antimicrobial therapy strategy in idiopathic pulmonary fibrosis patients. Our overall hypothesis is that reducing harmful microbial impact with antimicrobial therapy will reduce the risk of non-elective, respiratory hospitalization or death in patients with Idiopathic Pulmonary Fibrosis (IPF).
Subjects will be randomized 1:1 to either receive a prescription drug voucher for oral antimicrobial therapy in the form of one double strength 160 milligrams (mg) trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms (kg) or 100mg twice daily if weight > 50 kg. Patients randomized to receive antimicrobial therapy will be given co-trimoxazole unless they have an allergy, contraindication to co-trimoxazole, renal insufficiency (glomerular filtration rate (GFR) < 30 milliliters (ml)), are hyperkalemic (potassium > 5 milliequivalents(mEq)/liter(L)), or are concomitantly taking an angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), or potassium sparing diuretic in which case they will receive doxycycline.
Participation in this study will be between 12 months and 36 months depending on time of enrollment.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Antimicrobial therapy: Co-trimoxazole or Doxycycline, No Intervention: Standard of Care
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, pulmonary fibrosis, antimicrobial therapy, doxycycline, co-trimoxazole
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial therapy: Co-trimoxazole or DoxycyclineDrug
160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months
No Intervention: Standard of CareOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial therapy | Experimental | Co-trimoxazole OR doxycycline Receives: Drug: Antimicrobial therapy: Co-trimoxazole or Doxycycline |
| Standard of care | Other | Standard of care for patients with IPF for comparison Receives: Other: No Intervention: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality
Measured: Randomization to up to 35 months
Secondary outcomes (16)
Number of Participants With Death From Any Cause
Measured: Randomization to up to 35 months
Number of Participants With First Non-elective, Respiratory Hospitalization
Measured: Randomization to up to 35 months
Number of Participants With First Non-elective, All-cause Hospitalization
Measured: Randomization to up to 35 months
Total Number of Non-elective Respiratory Hospitalizations
Measured: Randomization to up to 35 months
Total Number of Non-elective All-cause Hospitalizations
Measured: Randomization to up to 35 months
Percent Change in Forced Vital Capacity (FVC)
Measured: Randomization to 12 months
Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)
Measured: Randomization to 12 months
Total Number of Respiratory Infections
Measured: Randomization to up to 35 months
Change in UCSD-Shortness of Breath Questionnaire
Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (0 - 120 range). A lower score indicates a better health score. The UCSD-Shortness of Breath Questionnaire assesses the severity of shortness of breath during specific activities of daily living.
Measured: Randomization to 12 months
Change in Fatigue Severity Scale Score
Fatigue Severity Scale score (1 - 7 range). A lower score indicates a better health score. The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle.
Measured: Randomization to 12 months
Change in Leicester Cough Questionnaire Score
Leicester Cough Questionnaire score (3 - 21 range). A higher score indicates a better health score. The Leicester Cough Questionnaire measures quality of life in people with a chronic cough.
Measured: Randomization to 12 months
Change in EuroQol Index (EQ-5D) Score
European Quality of Life-5 dimensions (EQ-5D) score (0 - 1 range). A higher score indicates a better health score. The EQ-5D measures quality of life across 5 dimensions (1. Mobility, 2. Self-care, 3. Usual activities, 4. Pain/discomfort, 5. Anxiety/depression.
Measured: Randomization to 12 months
Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score
Change in ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) score (0 - 1 range). A lower score indicates a better health score. The ICEpop CAPability measure for Older people (ICECAP-O) is intended for use in economic evaluations of care services for older people.
Measured: Randomization to 12 months
Change in Short Form-12 Health Survey (SF-12) 6D Score
Change in Short Form-12 health survey (SF-12) 6D score (0.29 - 1.00 range). A higher indicates a better health score. The SF-12 6D score provides and economic evaluation.
Measured: Randomization to 12 months
Change in Short Form-12 Health Survey (SF-12) Physical Score
Change in short form-12 health survey (SF-12) physical component summary (PSC) score (0 - 100 range). A higher score indicates a better health score.
The short form-12 health survey physical score assesses limitations in physical activities because of health problems.
Measured: Randomization to 12 months
Change in SF-12 Health Survey (SF-12) Mental Score
Change in short form-12 health survey (SF-12) mental component summary (MCS) score (0 - 100 range). A higher score indicates a better health score.
The short form-12 health survey (SF-12) mental component summary (MCS) assesses general mental health.
Measured: Randomization to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start22 Mar 2017
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: Terminated for futility after review of first planned interim analysis.
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 (3)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute, University of Chicago, University of Washington, University of Pittsburgh, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Fernando Martinez, MD, MS, Principal investigator, Weill Cornell Medical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759120
- Sponsor's protocol ID
- 1504016087
- Other IDs
- U01HL128954
- Acronym
- CleanUp-IPF
- Status last verified
- Mar 2021
- First submitted
- 28 Apr 2016
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be uploaded in a de-identified manner into BioLINCC with open access for interested investigators
Publications
Kim JS, Murray S, Yow E, Anstrom KJ, Kim HJ, Flaherty KR, Martinez FJ, Noth I. Comparison of Pirfenidone and Nintedanib: Post Hoc Analysis of the CleanUP-IPF Study. Chest. 2024 May;165(5):1163-1173. doi: 10.1016/j.chest.2023.11.035. Epub 2023 Nov 27.
PubMed 38030064Martinez FJ, Yow E, Flaherty KR, Snyder LD, Durheim MT, Wisniewski SR, Sciurba FC, Raghu G, Brooks MM, Kim DY, Dilling DF, Criner GJ, Kim H, Belloli EA, Nambiar AM, Scholand MB, Anstrom KJ, Noth I; CleanUP-IPF Investigators of the Pulmonary Trials Cooperative. Effect of Antimicrobial Therapy on Respiratory Hospitalization or Death in Adults With Idiopathic Pulmonary Fibrosis: The CleanUP-IPF Randomized Clinical Trial. JAMA. 2021 May 11;325(18):1841-1851. doi: 10.1001/jama.2021.4956.
PubMed 33974018Anstrom KJ, Noth I, Flaherty KR, Edwards RH, Albright J, Baucom A, Brooks M, Clark AB, Clausen ES, Durheim MT, Kim DY, Kirchner J, Oldham JM, Snyder LD, Wilson AM, Wisniewski SR, Yow E, Martinez FJ; CleanUP-IPF Study Team. Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy - the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial. Respir Res. 2020 Mar 12;21(1):68. doi: 10.1186/s12931-020-1326-1.
PubMed 32164673
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02759120
- Acronym / sponsor ID
- CleanUp-IPF / 1504016087
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, pulmonary fibrosis, antimicrobial therapy, doxycycline, co-trimoxazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated for futility after review of first planned interim analysis.
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute, University of Chicago, University of Washington, University of Pittsburgh, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Posted 3 Mar 2021
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 compare the effect of standard care, versus standard of care plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients diagnosed with idiopathic pulmonary fibrosis (IPF).
Detailed description
This is a randomized, un-blinded, phase III, multi-center clinical trial of an antimicrobial therapy strategy in idiopathic pulmonary fibrosis patients. Our overall hypothesis is that reducing harmful microbial impact with antimicrobial therapy will reduce the risk of non-elective, respiratory hospitalization or death in patients with Idiopathic Pulmonary Fibrosis (IPF).
Subjects will be randomized 1:1 to either receive a prescription drug voucher for oral antimicrobial therapy in the form of one double strength 160 milligrams (mg) trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms (kg) or 100mg twice daily if weight > 50 kg. Patients randomized to receive antimicrobial therapy will be given co-trimoxazole unless they have an allergy, contraindication to co-trimoxazole, renal insufficiency (glomerular filtration rate (GFR) < 30 milliliters (ml)), are hyperkalemic (potassium > 5 milliequivalents(mEq)/liter(L)), or are concomitantly taking an angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), or potassium sparing diuretic in which case they will receive doxycycline.
Participation in this study will be between 12 months and 36 months depending on time of enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial therapy | Experimental | Drug: Antimicrobial therapy: Co-trimoxazole or DoxycyclineCo-trimoxazole OR doxycycline |
| Standard of care | Other | Other: No Intervention: Standard of CareStandard of care for patients with IPF for comparison |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 40 years of age
- Diagnosed with idiopathic pulmonary fibrosis (IPF) by enrolling investigator
- Signed informed consent
Key exclusion criteria (13 listed)
- Received antimicrobial therapy in the past 30 days
- Contraindicated for antibiotic therapy, including but not exclusive to:
- Pregnant or anticipate becoming pregnant
- Use of an investigational study agent for IPF therapy within the past 30 days, or an IV infusion with a half-life of four (4) weeks.
- Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine.
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 therapy: Co-trimoxazole or Doxycycline160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months | Drug | Antimicrobial therapy |
| No Intervention: Standard of CareStandard of care | Other | Standard of care |
Primary outcome
Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality
Time frame: Randomization to up to 35 months
16 secondary outcomes
Number of Participants With Death From Any Cause
Time frame: Randomization to up to 35 months
Number of Participants With First Non-elective, Respiratory Hospitalization
Time frame: Randomization to up to 35 months
Number of Participants With First Non-elective, All-cause Hospitalization
Time frame: Randomization to up to 35 months
Total Number of Non-elective Respiratory Hospitalizations
Time frame: Randomization to up to 35 months
Total Number of Non-elective All-cause Hospitalizations
Time frame: Randomization to up to 35 months
Percent Change in Forced Vital Capacity (FVC)
Time frame: Randomization to 12 months
Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)
Time frame: Randomization to 12 months
Total Number of Respiratory Infections
Time frame: Randomization to up to 35 months
Change in UCSD-Shortness of Breath Questionnaire
Time frame: Randomization to 12 months
Change in Fatigue Severity Scale Score
Time frame: Randomization to 12 months
Change in Leicester Cough Questionnaire Score
Time frame: Randomization to 12 months
Change in EuroQol Index (EQ-5D) Score
Time frame: Randomization to 12 months
Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score
Time frame: Randomization to 12 months
Change in Short Form-12 Health Survey (SF-12) 6D Score
Time frame: Randomization to 12 months
Change in Short Form-12 Health Survey (SF-12) Physical Score
Time frame: Randomization to 12 months
Change in SF-12 Health Survey (SF-12) Mental Score
Time frame: Randomization to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38030064Kim JS, Murray S, Yow E, Anstrom KJ, Kim HJ, Flaherty KR, Martinez FJ, Noth I. Comparison of Pirfenidone and Nintedanib: Post Hoc Analysis of the CleanUP-IPF Study. Chest. 2024 May;165(5):1163-1173. doi: 10.1016/j.chest.2023.11.035. Epub 2023 Nov 27.
- Derived from this study: PubMed 33974018Martinez FJ, Yow E, Flaherty KR, Snyder LD, Durheim MT, Wisniewski SR, Sciurba FC, Raghu G, Brooks MM, Kim DY, Dilling DF, Criner GJ, Kim H, Belloli EA, Nambiar AM, Scholand MB, Anstrom KJ, Noth I; CleanUP-IPF Investigators of the Pulmonary Trials Cooperative. Effect of Antimicrobial Therapy on Respiratory Hospitalization or Death in Adults With Idiopathic Pulmonary Fibrosis: The CleanUP-IPF Randomized Clinical Trial. JAMA. 2021 May 11;325(18):1841-1851. doi: 10.1001/jama.2021.4956.
- Derived from this study: PubMed 32164673Anstrom KJ, Noth I, Flaherty KR, Edwards RH, Albright J, Baucom A, Brooks M, Clark AB, Clausen ES, Durheim MT, Kim DY, Kirchner J, Oldham JM, Snyder LD, Wilson AM, Wisniewski SR, Yow E, Martinez FJ; CleanUP-IPF Study Team. Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy - the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial. Respir Res. 2020 Mar 12;21(1):68. doi: 10.1186/s12931-020-1326-1.
- Individual participant dataSharing planned: Yes. All collected IPD will be uploaded in a de-identified manner into BioLINCC with open access for interested investigators
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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.
Fernando Martinez, MD, MS principal investigator
Weill Cornell Medical Medicine
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antimicrobial therapy: Co-trimoxazole or Doxycycline in people with Idiopathic Pulmonary Fibrosis, run by Weill Medical College of Cornell University at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2021). 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?
Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality (time frame: Randomization to up to 35 months). 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 NCT02759120, which also lists 3 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 8 Apr 2021.