COVID-19 PneumoniaPhase 3BESTNCT04305106
Bevacizumab in Patients With Severe Covid-19
A Phase 3 study testing Bevacizumab in people with COVID-19 Pneumonia, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The novel coronavirus (SARS-CoV-2) is a new strain of coronavirus found in human in 2019, which causes epidemic worldwide. Novel coronavirus disease (COVID-19) causes acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in patients with severe COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 588 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2023to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old, both genders;
- Confirmed COVID-19 diagnosis (any body fluid tested positive for SARS-CoV-2 nucleic acid by PCR, or positive for SARS-CoV-2 antigen);
- Respiratory rate ≥ 30 times/min, partial pressure of oxygen (PaO2)/ fraction of inspiration O2 (FiO2)≤ 300mmHg (1mmHg = 0.133kPa), or SpO2 ≤ 93% at rest without supplemental oxygen;
- Article (3) above is newly appeared within 7 days;
- Chest radiography or computed tomography shows bilateral chest infiltrates.
Who cannot join
- Unable to obtain informed consent.
- Physician with more than 5 years of clinical experience determines that death was inevitable within 24 hours.
- Severe hepatic dysfunction (Child Pugh score ≥ C, or AST> 5 times the upper limit); Severe renal dysfunction (estimated glomerular filtration rate ≤ 30mL/ min/1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
- Uncontrolled hypertension (sitting systolic blood pressure> 160mmHg, or diastolic blood pressure>100mmHg); previous history of hypertension crisis or hypertensive encephalopathy.
- Poorly controlled heart diseases, such as NYHA class II and above cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia need treatment or intervention.
- Severe or above chronic obstructive pulmonary disease (GOLD grade, FEV1/FVC < 0.5).
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- Hereditary bleeding tendency or coagulopathy;
- Arterial/venous thromboembolic events within 6 months before enrollment, such as ischemic stroke, transient ischemic attack, deep venous thrombosis, pulmonary embolism, etc. Severe vascular disease (including aneurysms or arterial thrombosis requiring surgery) within 6 months before enrollment.
- Unhealed wounds, active gastric ulcers or fractures. Gastrointestinal perforation, gastrointestinal fistula, abdominal abscess, visceral fistula formation within 6 months before enrollment. Major surgery (including preoperative Chest biopsy) or major trauma (such as a fracture) within 28 days before enrollment. May have surgery during the trial.
- Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous system bleeding, and nosebleeds within 1 month before enrollment.
- Malignant tumors within 5 years before enrollment.
- Allergic to bevacizumab or its components.
- Active tuberculosis, uncontrollable infection, untreated active hepatitis or HIV-positive patients.
- Pregnant and lactating women and those planning to get pregnant.
- Participated in other clinical trials, not considered suitable for this study by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jiaojiao Pang, Dr, +86 18560089129, jiaojiaopang@126.com
About this study
Official title: The Efficacy and Safety of Bevacizumab in Patients With Severe Covid-19: a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial
The novel coronavirus (SARS-CoV-2) is a new strain of coronavirus found in human in 2019, which causes epidemic worldwide. Novel coronavirus disease (COVID-19) causes acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in patients with severe COVID-19. Pulmonary edema is the key detrimental feature of ALI/ARDS. Autopsy of patients died from COVID-19 reported that, pulmonary mucus exudation was more severe and obvious than SARS infection. Pulmonary CT scanning and pathological findings also suggest that pulmonary edema caused by inflammatory exudation is a distinguished feature of COVID-19. Vascular endothelial growth factor (VEGF), also known as vascular permeability factor (VPF), is known as the most potent factor to increase vascular permeability, with the induction effect 50,000 times stronger than histamine. Bevacizumab is an anti-VEGF recombinant humanized monoclonal antibody, which has been used in anti-tumor treatment since 2004, with considerable reliability and clinical safety. This trial will provide high level evidence to answer whether bevacizumab is efficacy and safe medication for patients with severe COVID-19.
Read the detailed description
Evident increase of VEGF levels in serum has been displayed on novel pneumonia patients. The investigators also conducted a pilot study of 93 patients with severe COVID-19 that confirmed the significantly elevated level of plasma and serum VEGF.
At the beginning of 2020, the investigators proposed the concept of using anti-VEGF treatment for patients with severe COVID-19 and conducted a pilot study (NCT04275414). Among the 27 enrolled participants treated with bevacizumab, it was found that the clinical recovery status, PaO2/FiO2, and pulmonary exudation on imaging were significantly improved than the external controls in the same center during the same period. This provides good preliminary basis for this RCT.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Bevacizumab, Placebo, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Recombinant anti-VEGF humanized monoclonal antibody injection
Bevacizumab (7.5mg/kg BW) + Saline (100ml) Bevacizumab will be administered in a single dose with no less than 90 minutes of intravenous infusion under ECG monitoring.
PlaceboOther
Also called Inactive excipient
Placebo (7.5mg/kg BW) + Saline (100ml) The placebo drug will be administered in a single dose with no less than 90 minutes of intravenous infusion under ECG monitoring.
Standard careOther
Standard care, including prophylactic doses of low molecular weight heparin or unfractionated heparin without contraindications, and therapeutic doses of anticoagulants with the evidence of thrombosis risk or occurrence.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Bevacizumab 7.5mg/kg body weight, intravenous drip, single-dose administration, and standard of care, including prophylactic doses of low molecular weight heparin or unfractionated heparin without contraindications, and therapeutic doses of anticoagulants with the evidence of thrombosis risk or occurrence. Receives: Drug: Bevacizumab; Other: Standard care |
| Placebo | Placebo comparator | Placebo (inactive excipient) 7.5mg/kg body weight, intravenous drip, single-dose administration, and standard of care, including prophylactic doses of low molecular weight heparin or unfractionated heparin without contraindications, and therapeutic doses of anticoagulants with the evidence of thrombosis risk or occurrence. Receives: Other: Placebo; Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time from randomization to clinical improvement
The time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever comes first.
Measured: 28 days
Secondary outcomes (11)
Intubation rate
Intubation rate
Measured: From date of randomization until the date of discharge, up to 28 days
Duration of mechanical ventilation (days)
Days of mechanical ventilation
Measured: From date of randomization until the date of discharge, up to 28 days
Duration of non-invasive ventilator or nasal high flow oxygen inhalation
Days of non-invasive ventilator or nasal high flow oxygen inhalation
Measured: From date of randomization until the date of discharge, up to 28 days
All-cause mortality
All-cause mortality
Measured: From date of randomization until the date of discharge, up to 60 days
Time to reach level 1 on the seven-category ordinal scale
Days from randomization to the clinical status of reaching level 1 on the seven--category ordinal scale
Measured: up to 60 days
PaO2/FiO2 level
The ratio of partial pressure of oxygen to fraction of inspiration O2
Measured: day 1, day 3, day 7 and day 14 after randomization, or before discharge
Improvement of pulmonary lesions
The change of volumes of pulmonary exudation shown on CT compared to baseline
Measured: day 7 and day 14 after randomization, or before discharge
Improvement of lymphocyte count
The change of the level of lymphocyte count compared to baseline
Measured: day 7 and day 14 after randomization, or before discharge
Improvement of CRP
The change of the level of C-reactive protein compared to baseline
Measured: day 7 and day 14 after randomization, or before discharge
Improvement of LDH
The change of the level of lactate dehydrogenase compared to baseline
Measured: day 7 and day 14 after randomization, or before discharge
SAE, AE
Serious adverse event, adverse event
Measured: From date of randomization until the date of discharge, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start12 Jan 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Renmin Hospital of Wuhan University, Second Affiliated Hospital of Xi'an Jiaotong University, Zhejiang Provincial People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Anqing Municipal Hospital, First Affiliated Hospital of Wannan Medical College, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Shandong Provincial Hospital, Linyi People's Hospital, Jining Medical University, Jining First People's Hospital, Weifang Second People's Hospital, Weifang Medical University, Yantai Yuhuangding Hospital, Weihai Municipal Hospital, Rizhao People's Hospital, Qingdao Municipal Hospital, Qilu Hospital of Shandong University (Qingdao), Weifang People's Hospital, Weifang Hospital of Traditional Chinese Medicine, Zibo Central Hospital, Zibo Municipal Hospital
- Responsible party
- Sponsor
- Investigators
- Yihai Cao, Dr, Principal investigator, Qilu Hospital of Shandong University, Karolinska InstitutetYuguo Chen, Dr, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305106
- Sponsor's protocol ID
- QLEmer
- Acronym
- BEST
- Status last verified
- Jan 2023
- First submitted
- 9 Mar 2020
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the study protocol, SAP, ICF, CSR and analytic code on the day of article publication.
Publications
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Pang J, Xu F, Aondio G, Li Y, Fumagalli A, Lu M, Valmadre G, Wei J, Bian Y, Canesi M, Damiani G, Zhang Y, Yu D, Chen J, Ji X, Sui W, Wang B, Wu S, Kovacs A, Revera M, Wang H, Jing X, Zhang Y, Chen Y, Cao Y. Efficacy and tolerability of bevacizumab in patients with severe Covid-19. Nat Commun. 2021 Feb 5;12(1):814. doi: 10.1038/s41467-021-21085-8.
PubMed 33547300
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Bevacizumab in Patients With Severe Covid-19: a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04305106
- Acronym / sponsor ID
- BEST / QLEmer
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Renmin Hospital of Wuhan University, Second Affiliated Hospital of Xi'an Jiaotong University, Zhejiang Provincial People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Anqing Municipal Hospital, First Affiliated Hospital of Wannan Medical College, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Shandong Provincial Hospital, Linyi People's Hospital, Jining Medical University, Jining First People's Hospital, Weifang Second People's Hospital, Weifang Medical University, Yantai Yuhuangding Hospital, Weihai Municipal Hospital, Rizhao People's Hospital, Qingdao Municipal Hospital, Qilu Hospital of Shandong University (Qingdao), Weifang People's Hospital, Weifang Hospital of Traditional Chinese Medicine, Zibo Central Hospital, Zibo Municipal Hospital
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Mar 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.
The novel coronavirus (SARS-CoV-2) is a new strain of coronavirus found in human in 2019, which causes epidemic worldwide. Novel coronavirus disease (COVID-19) causes acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in patients with severe COVID-19. Pulmonary edema is the key detrimental feature of ALI/ARDS. Autopsy of patients died from COVID-19 reported that, pulmonary mucus exudation was more severe and obvious than SARS infection. Pulmonary CT scanning and pathological findings also suggest that pulmonary edema caused by inflammatory exudation is a distinguished feature of COVID-19. Vascular endothelial growth factor (VEGF), also known as vascular permeability factor (VPF), is known as the most potent factor to increase vascular permeability, with the induction effect 50,000 times stronger than histamine. Bevacizumab is an anti-VEGF recombinant humanized monoclonal antibody, which has been used in anti-tumor treatment since 2004, with considerable reliability and clinical safety. This trial will provide high level evidence to answer whether bevacizumab is efficacy and safe medication for patients with severe COVID-19.
Detailed description
Evident increase of VEGF levels in serum has been displayed on novel pneumonia patients. The investigators also conducted a pilot study of 93 patients with severe COVID-19 that confirmed the significantly elevated level of plasma and serum VEGF.
At the beginning of 2020, the investigators proposed the concept of using anti-VEGF treatment for patients with severe COVID-19 and conducted a pilot study (NCT04275414). Among the 27 enrolled participants treated with bevacizumab, it was found that the clinical recovery status, PaO2/FiO2, and pulmonary exudation on imaging were significantly improved than the external controls in the same center during the same period. This provides good preliminary basis for this RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: Bevacizumab, Other: Standard careBevacizumab 7.5mg/kg body weight, intravenous drip, single-dose administration, and standard of care, including prophylactic doses of low molecular weight heparin or unfractionated heparin without contraindications, and therapeutic doses of anticoagulants with the evidence of thrombosis risk or occurrence. |
| Placebo | Placebo comparator | Other: Placebo, Other: Standard carePlacebo (inactive excipient) 7.5mg/kg body weight, intravenous drip, single-dose administration, and standard of care, including prophylactic doses of low molecular weight heparin or unfractionated heparin without contraindications, and therapeutic doses of anticoagulants with the evidence of thrombosis risk or occurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: ≥18 years old, both genders;
- Confirmed COVID-19 diagnosis (any body fluid tested positive for SARS-CoV-2 nucleic acid by PCR, or positive for SARS-CoV-2 antigen);
- Respiratory rate ≥ 30 times/min, partial pressure of oxygen (PaO2)/ fraction of inspiration O2 (FiO2)≤ 300mmHg (1mmHg = 0.133kPa), or SpO2 ≤ 93% at rest without supplemental oxygen;
- Article (3) above is newly appeared within 7 days;
- Chest radiography or computed tomography shows bilateral chest infiltrates.
Key exclusion criteria (15 listed)
- Unable to obtain informed consent.
- Physician with more than 5 years of clinical experience determines that death was inevitable within 24 hours.
- Severe hepatic dysfunction (Child Pugh score ≥ C, or AST> 5 times the upper limit); Severe renal dysfunction (estimated glomerular filtration rate ≤ 30mL/ min/1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
- Uncontrolled hypertension (sitting systolic blood pressure> 160mmHg, or diastolic blood pressure>100mmHg); previous history of hypertension crisis or hypertensive encephalopathy.
- Poorly controlled heart diseases, such as NYHA class II and above cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia need treatment or intervention.
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 |
|---|---|---|
| BevacizumabAlso: Recombinant anti-VEGF humanized monoclonal antibody injectionBevacizumab (7.5mg/kg BW) + Saline (100ml) Bevacizumab will be administered in a single dose with no less than 90 minutes of intravenous infusion under ECG monitoring. | Drug | Bevacizumab |
| PlaceboAlso: Inactive excipientPlacebo (7.5mg/kg BW) + Saline (100ml) The placebo drug will be administered in a single dose with no less than 90 minutes of intravenous infusion under ECG monitoring. | Other | Placebo |
| Standard careStandard care, including prophylactic doses of low molecular weight heparin or unfractionated heparin without contraindications, and therapeutic doses of anticoagulants with the evidence of thrombosis risk or occurrence. | Other | Bevacizumab, Placebo |
Primary outcome
The time from randomization to clinical improvement
Time frame: 28 days
The time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever comes first.
11 secondary outcomes
Intubation rate
Time frame: From date of randomization until the date of discharge, up to 28 days
Duration of mechanical ventilation (days)
Time frame: From date of randomization until the date of discharge, up to 28 days
Duration of non-invasive ventilator or nasal high flow oxygen inhalation
Time frame: From date of randomization until the date of discharge, up to 28 days
All-cause mortality
Time frame: From date of randomization until the date of discharge, up to 60 days
Time to reach level 1 on the seven-category ordinal scale
Time frame: up to 60 days
PaO2/FiO2 level
Time frame: day 1, day 3, day 7 and day 14 after randomization, or before discharge
Improvement of pulmonary lesions
Time frame: day 7 and day 14 after randomization, or before discharge
Improvement of lymphocyte count
Time frame: day 7 and day 14 after randomization, or before discharge
Improvement of CRP
Time frame: day 7 and day 14 after randomization, or before discharge
Improvement of LDH
Time frame: day 7 and day 14 after randomization, or before discharge
SAE, AE
Time frame: From date of randomization until the date of discharge, up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 33547300Pang J, Xu F, Aondio G, Li Y, Fumagalli A, Lu M, Valmadre G, Wei J, Bian Y, Canesi M, Damiani G, Zhang Y, Yu D, Chen J, Ji X, Sui W, Wang B, Wu S, Kovacs A, Revera M, Wang H, Jing X, Zhang Y, Chen Y, Cao Y. Efficacy and tolerability of bevacizumab in patients with severe Covid-19. Nat Commun. 2021 Feb 5;12(1):814. doi: 10.1038/s41467-021-21085-8.
- Individual participant dataSharing planned: Yes. We will share the study protocol, SAP, ICF, CSR and analytic code on the day of article publication.
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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.
Yihai Cao, Dr principal investigator
Qilu Hospital of Shandong University, Karolinska Institutet
Yuguo Chen, Dr principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab in people with COVID-19 Pneumonia, run by Qilu Hospital of Shandong University at 1 site in China.
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 15 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiaojiao Pang, Dr (18560089129, jiaojiaopang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time from randomization to clinical improvement (time frame: 28 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 NCT04305106, which also lists 2 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 27 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.