Covid19NCT04507893
Comparison Between Positive and Negative COVID-19 Pneumonia
An observational study of Covid19 and Interstitial Pneumonia, run by University of Palermo at 3 sites in Italy.
Trial summary
In the late 2019 a new Coronavirus was identified as the cause of a group of atypical interstitial pneumonia cases in Wuhan, a city in the Chinese province of Hubei. In February 2020, the World Health Organization designated COVID-19 disease, which stands for Coronavirus 2019 disease. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Covid19, Interstitial Pneumonia
- What is being tested?
- Clinical, laboratory and imaging characteristics of pneumonia
- How many people
- 80 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Mar 2020to 1 Apr 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective, multicenter study, conducted on patients with interstitial pneumonia, admitted, consecutively, to the Internal Medicine I Unit of the "Villa Sofia - Cervello" Hospitals of Palermo, and two other Units dedicated to Patients affected with COVID-19, in the same hospital, from March 15, 2020 to May 31, 2020.
Who may be able to join
- All consecutive patients referred to the Emergency Unit of the "V. Cervello" Hospital, in Palermo, Italy, for clinical symptoms suggestive of suspected COVID-19 infection.
- In details, we consider patients referred for one or more of the following manifestations: respiratory symptoms, fever, taste or smell loss.
- To be included their records must include:
- detailed clinical history
- radiological findings (High-resolution CT, HRCT)
- results of viral RNA research for SARS-COV2, by PCR on nasopharyngeal swab, repeated two times (at the admission and again after 48 hours from the admission in the Emergency Unit)
Show all 9Show fewer
- laboratory results regarding routine hemato-chemical assays
- oxygen therapy
- treatment used.
Who cannot join
- age <18 years
- incomplete medical records with respect to the parameters sought
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Infectious diseases Unit of the "Cervello-Villa Sofia" Hospital
Palermo, PA, 90146
Internal Medicine Division of the "Cervello-Villa Sofia" Hospital
Palermo, PA, 90146
Pulmonology Unit Dedicated to COVID-19 Patients
Palermo, PA, 90146
About this study
Official title: Clinical, Laboratory and Imaging Comparison Between COVID-19 Pneumonia Confirmed by PCR Detection on Nasopharyngeal Swab and Negative Swab Pneumonia
In the late 2019 a new Coronavirus was identified as the cause of a group of atypical interstitial pneumonia cases in Wuhan, a city in the Chinese province of Hubei. In February 2020, the World Health Organization designated COVID-19 disease, which stands for Coronavirus 2019 disease. Following the progressive spread of the infection in other countries of the world, WHO declared the Pandemic on 11 March 2020. Italy was the first European country involved in the spread of the infection and among those with the highest number of victims. The Coronavirus responsible for COVID-19 has, as its main target organ, the respiratory system, being able to determine a serious acute respiratory syndrome similar to that of the cases found during the SARS epidemic of 2003: hence the name of the virus as SARS-CoV-2. The diagnosis of SARS-COV-2 infection is made by direct detection by PCR of viral RNA on different biological materials from patients with suspicious symptoms, and the first level diagnostic test is generally the nasopharyngeal swab. However, even if the specificity of the nasopharyngeal swab is high, its sensitivity can be affected by technical causes (sampling mode), as well as by intrinsic factors related to the method. The purpose of the study is to identify the clinical, laboratory and imaging characteristic which are similar or which can differentiate the hospitalized patients affected by COVID-19 pneumonia (with positive PCR on naso-pharyngeal swab) and patients with pneumonia with negative PCR for COVID-19. To do this, the investigators will compare the clinical, laboratory and imaging characteristics between interstitial pneumonia secondary to SARS-COV-2 infection, confirmed by molecular biology investigations (viral RNA research by PCR on nasopharyngeal swab) and cases of interstitial pneumonia negative to the nasopharyngeal swab.
Read the detailed description
In the late 2019 a new Coronavirus was identified as the cause of a group of atypical interstitial pneumonia cases in Wuhan, a city in the Chinese province of Hubei. In February 2020, the World Health Organization designated COVID-19 disease, which stands for Coronavirus 2019 disease. Following the progressive spread of the infection in other countries of the world, WHO declared the Pandemic on 11 March 2020. Italy was the first European country involved in the spread of the infection and among those with the highest number of victims. The Coronavirus responsible for COVID-19 has, as its main target organ, the respiratory system, being able to determine a serious acute respiratory syndrome similar to that of the cases found during the SARS epidemic of 2003: hence the name of the virus as SARS-CoV-2. Multisystem involvement and hyperinflammatory organ and systemic response are responsible for the patient's death. Overall, hospital mortality from COVID-19 is approximately 15% to 20%, but up to 40% among patients requiring ICU admission. The diagnosis of SARS-COV-2 infection is made by direct detection of viral RNA on different biological materials from patients with suspicious symptoms, and the first level diagnostic test is generally the nasopharyngeal swab; molecular investigations can also be carried out on samples from the distal respiratory tract (BronchoAlveolar Lavage, BAL). However, even if the specificity of the nasopharyngeal swab is high, its sensitivity can be affected by technical causes (sampling mode), as well as by intrinsic factors related to the method. The sensitivity data available are around 40-70%. The result is the possibility of a consistent series of false negatives (at least one third), represented by patients which have clinical characteristics compatible with SARS-COV-2 infection, but resulted, however, negative to the nasopharyngeal swab. These cases are framed as COVID-19-like cases and constitute a serious problem for the risk of not to recognize hospitalized patients suffering from COVID-19 infection.
The purpose of the study is to identify the clinical, laboratory and imaging characteristic which are similar or which can differentiate the hospitalized patients affected by COVID-19 pneumonia (with positive PCR on naso-pharyngeal swab) and patients with pneumonia with negative PCR for COVID-19. To do this, the investigators will compare the clinical, laboratory and imaging characteristics between interstitial pneumonia secondary to SARS-COV-2 infection, confirmed by molecular biology investigations (viral RNA research by PCR on nasopharyngeal swab) and cases of interstitial pneumonia negative to the nasopharyngeal swab. The cases studied will be represented by patients hospitalized for interstitial pneumonia in the participating hospital centers in the period between mid-March 2020 and end of May 2020. For these cases, all available data contained in the medical records of patients, enrolled within the time frame indicated above, will be retrospectively analyzed. Due to relative lack of sensitivity of COVID-19 PCR assay in nasopharyngeal swab, patients affected with COVID-19 infection can be mixed with other hospitalized patients and with unprotected health staff. On the basis of the comparison of the clinical, laboratory and imaging data the study would identify the characteristics which can differentiate patients with SARS-COV-2 pneumonia, confirmed by nasopharyngeal swab, and interstitial pneumonia and negative COVID-19 PCR on swab. The investigators aim to highlight any similarities or differences or the need for differentiated treatments.
- Conditions
- Covid19, Interstitial Pneumonia
- Being tested
- Clinical, laboratory and imaging characteristics of pneumonia
- Medical subject headings
- COVID-19, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical, laboratory and imaging characteristics of pneumoniaOther
Evaluation of the clinical, laboratory and imaging characteristics in patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "negative COVID-19 patients".
| Study group | Role | What they receive |
|---|---|---|
| SARS-COV-2 PNEUMONIA CONFIRMED BY PCR ON NASOPHARYNGEAL SWAB | Hospitalized patients affected by COVID-19 interstitial pneumonia (with positive PCR on naso-pharyngeal swab) Receives: Other: Clinical, laboratory and imaging characteristics of pneumonia | |
| NEGATIVE SARS-COV-2 PNEUMONIA | Hospitalized patients affected by negative COVID-19 interstitial pneumonia (with negative PCR on naso-pharyngeal swab) Receives: Other: Clinical, laboratory and imaging characteristics of pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the clinical characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Accuracy of severity of respiratory insufficiency - evaluated as need of three step "nasal oxygen, oxygen mask, invasive ventilation" - in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls"
Measured: 75 Days
Evaluation of the laboratory characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Accuracy of the association of 3 haemato-chemical abnormalities (lymphopenia + increased serum transaminases + increased serum LDH) in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls".
Measured: 75 Days
Evaluation of the imaging characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Accuracy of thorax CT scan in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls".
Measured: 75 Days
Secondary outcomes (3)
Evaluation of mortality of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Evaluation of mortality in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.
Measured: 75 Days
Evaluation of clinical severity of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Evaluation of clinical severity in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.
Measured: 75 Days
Evaluation of hospital stay length of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Evaluation of hospital stay length in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.
Measured: 75 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start15 Mar 2020
- Primary completion30 Sep 2020
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasquale Mansueto, University of Palermo
- Investigators
- Antonio Carroccio, MD, Principal investigator, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507893
- Sponsor's protocol ID
- ACPM26
- Status last verified
- May 2022
- First submitted
- 5 Aug 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Mitri C, Arcoleo G, Mazzuca E, Camarda G, Farinella EM, Soresi M, Carroccio A; IMUSG. COVID-19 and non-COVID-19 pneumonia: a comparison. Ann Med. 2021 Dec;53(1):2321-2331. doi: 10.1080/07853890.2021.2010797.
PubMed 34854790
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Laboratory and Imaging Comparison Between COVID-19 Pneumonia Confirmed by PCR Detection on Nasopharyngeal Swab and Negative Swab Pneumonia
- ClinicalTrials.gov ID
- NCT04507893
- Acronym / sponsor ID
- ACPM26
- Conditions
- Covid19, Interstitial Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 11 Aug 2020 (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.
In the late 2019 a new Coronavirus was identified as the cause of a group of atypical interstitial pneumonia cases in Wuhan, a city in the Chinese province of Hubei. In February 2020, the World Health Organization designated COVID-19 disease, which stands for Coronavirus 2019 disease. Following the progressive spread of the infection in other countries of the world, WHO declared the Pandemic on 11 March 2020. Italy was the first European country involved in the spread of the infection and among those with the highest number of victims. The Coronavirus responsible for COVID-19 has, as its main target organ, the respiratory system, being able to determine a serious acute respiratory syndrome similar to that of the cases found during the SARS epidemic of 2003: hence the name of the virus as SARS-CoV-2. The diagnosis of SARS-COV-2 infection is made by direct detection by PCR of viral RNA on different biological materials from patients with suspicious symptoms, and the first level diagnostic test is generally the nasopharyngeal swab. However, even if the specificity of the nasopharyngeal swab is high, its sensitivity can be affected by technical causes (sampling mode), as well as by intrinsic factors related to the method. The purpose of the study is to identify the clinical, laboratory and imaging characteristic which are similar or which can differentiate the hospitalized patients affected by COVID-19 pneumonia (with positive PCR on naso-pharyngeal swab) and patients with pneumonia with negative PCR for COVID-19. To do this, the investigators will compare the clinical, laboratory and imaging characteristics between interstitial pneumonia secondary to SARS-COV-2 infection, confirmed by molecular biology investigations (viral RNA research by PCR on nasopharyngeal swab) and cases of interstitial pneumonia negative to the nasopharyngeal swab.
Detailed description
In the late 2019 a new Coronavirus was identified as the cause of a group of atypical interstitial pneumonia cases in Wuhan, a city in the Chinese province of Hubei. In February 2020, the World Health Organization designated COVID-19 disease, which stands for Coronavirus 2019 disease. Following the progressive spread of the infection in other countries of the world, WHO declared the Pandemic on 11 March 2020. Italy was the first European country involved in the spread of the infection and among those with the highest number of victims. The Coronavirus responsible for COVID-19 has, as its main target organ, the respiratory system, being able to determine a serious acute respiratory syndrome similar to that of the cases found during the SARS epidemic of 2003: hence the name of the virus as SARS-CoV-2. Multisystem involvement and hyperinflammatory organ and systemic response are responsible for the patient's death. Overall, hospital mortality from COVID-19 is approximately 15% to 20%, but up to 40% among patients requiring ICU admission. The diagnosis of SARS-COV-2 infection is made by direct detection of viral RNA on different biological materials from patients with suspicious symptoms, and the first level diagnostic test is generally the nasopharyngeal swab; molecular investigations can also be carried out on samples from the distal respiratory tract (BronchoAlveolar Lavage, BAL). However, even if the specificity of the nasopharyngeal swab is high, its sensitivity can be affected by technical causes (sampling mode), as well as by intrinsic factors related to the method. The sensitivity data available are around 40-70%. The result is the possibility of a consistent series of false negatives (at least one third), represented by patients which have clinical characteristics compatible with SARS-COV-2 infection, but resulted, however, negative to the nasopharyngeal swab. These cases are framed as COVID-19-like cases and constitute a serious problem for the risk of not to recognize hospitalized patients suffering from COVID-19 infection.
The purpose of the study is to identify the clinical, laboratory and imaging characteristic which are similar or which can differentiate the hospitalized patients affected by COVID-19 pneumonia (with positive PCR on naso-pharyngeal swab) and patients with pneumonia with negative PCR for COVID-19. To do this, the investigators will compare the clinical, laboratory and imaging characteristics between interstitial pneumonia secondary to SARS-COV-2 infection, confirmed by molecular biology investigations (viral RNA research by PCR on nasopharyngeal swab) and cases of interstitial pneumonia negative to the nasopharyngeal swab. The cases studied will be represented by patients hospitalized for interstitial pneumonia in the participating hospital centers in the period between mid-March 2020 and end of May 2020. For these cases, all available data contained in the medical records of patients, enrolled within the time frame indicated above, will be retrospectively analyzed. Due to relative lack of sensitivity of COVID-19 PCR assay in nasopharyngeal swab, patients affected with COVID-19 infection can be mixed with other hospitalized patients and with unprotected health staff. On the basis of the comparison of the clinical, laboratory and imaging data the study would identify the characteristics which can differentiate patients with SARS-COV-2 pneumonia, confirmed by nasopharyngeal swab, and interstitial pneumonia and negative COVID-19 PCR on swab. The investigators aim to highlight any similarities or differences or the need for differentiated treatments.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-COV-2 PNEUMONIA CONFIRMED BY PCR ON NASOPHARYNGEAL SWAB | – | Other: Clinical, laboratory and imaging characteristics of pneumoniaHospitalized patients affected by COVID-19 interstitial pneumonia (with positive PCR on naso-pharyngeal swab) |
| NEGATIVE SARS-COV-2 PNEUMONIA | – | Other: Clinical, laboratory and imaging characteristics of pneumoniaHospitalized patients affected by negative COVID-19 interstitial pneumonia (with negative PCR on naso-pharyngeal swab) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective, multicenter study, conducted on patients with interstitial pneumonia, admitted, consecutively, to the Internal Medicine I Unit of the "Villa Sofia - Cervello" Hospitals of Palermo, and two other Units dedicated to Patients affected with COVID-19, in the same hospital, from March 15, 2020 to May 31, 2020.
Key inclusion criteria (9 listed)
- All consecutive patients referred to the Emergency Unit of the "V. Cervello" Hospital, in Palermo, Italy, for clinical symptoms suggestive of suspected COVID-19 infection.
- In details, we consider patients referred for one or more of the following manifestations: respiratory symptoms, fever, taste or smell loss.
- detailed clinical history
- radiological findings (High-resolution CT, HRCT)
- results of viral RNA research for SARS-COV2, by PCR on nasopharyngeal swab, repeated two times (at the admission and again after 48 hours from the admission in the Emergency Unit)
Key exclusion criteria (2 listed)
- age <18 years
- incomplete medical records with respect to the parameters sought
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 |
|---|---|---|
| Clinical, laboratory and imaging characteristics of pneumoniaEvaluation of the clinical, laboratory and imaging characteristics in patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "negative COVID-19 patients". | Other | NEGATIVE SARS-COV-2 PNEUMONIA, SARS-COV-2 PNEUMONIA CONFIRMED BY PCR ON NASOPHARYNGEAL SWAB |
Primary outcome
Evaluation of the clinical characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Time frame: 75 Days
Accuracy of severity of respiratory insufficiency - evaluated as need of three step "nasal oxygen, oxygen mask, invasive ventilation" - in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls"
Evaluation of the laboratory characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Time frame: 75 Days
Accuracy of the association of 3 haemato-chemical abnormalities (lymphopenia + increased serum transaminases + increased serum LDH) in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls".
Evaluation of the imaging characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Time frame: 75 Days
Accuracy of thorax CT scan in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls".
3 secondary outcomes
Evaluation of mortality of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Time frame: 75 Days
Evaluation of clinical severity of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Time frame: 75 Days
Evaluation of hospital stay length of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls".
Time frame: 75 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 18 May 2022.
- Derived from this study: PubMed 34854790Di Mitri C, Arcoleo G, Mazzuca E, Camarda G, Farinella EM, Soresi M, Carroccio A; IMUSG. COVID-19 and non-COVID-19 pneumonia: a comparison. Ann Med. 2021 Dec;53(1):2321-2331. doi: 10.1080/07853890.2021.2010797.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Carroccio, MD principal investigator
University of Palermo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Interstitial Pneumonia, run by University of Palermo at 3 sites in Italy.
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 9 inclusion and 2 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 18 May 2022. 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 Italy. 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?
Evaluation of the clinical characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls". (time frame: 75 Days). 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 NCT04507893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.