Corona Virus InfectionPhase 2/3NCT04418128
Clinical Efficacy of Nafamostat Mesylate for COVID-19 Pneumonia
A Phase 2/3 study testing Nafamostat Mesylate in people with Corona Virus Infection and COVID-19, run by Gyeongsang National University Hospital.
Trial summary
In-vitro studies revealed that nafamostat mesylate has antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and anti-inflammatory and anti-coagulation effect. However, there is no clinical studies on the efficacy of nafamostat in patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Corona Virus Infection, COVID-19
- What is being tested?
- Nafamostat Mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2020to 30 Apr 2021
- Phase
- Phase 2/3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Patients who have been confirmed of COVID-19 infection and has evidence for pneumonia
- Confirmation of COVID-19 infection by RT-PCR of SARS-CoV-2
- Definite diagnosis of new infiltration of the lungs by chest CT scan of chest radiographic inspection
- Patients who are within 72 hours of COVID-19 pneumonia confirmation
- Patients with 3(hospitalization, not requiring supplemental oxygen) or higher in seven-category ordinal scale of clinical status
Show all 16Show fewer
- Seven-category ordinal scale of clinical status
- not hospitalized with resumption of normal activities;
- not hospitalized, but unable to resume normal activities;
- hospitalization, not requiring supplemental oxygen;
- hospitalization, requiring supplemental oxygen;
- hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation;
- hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation;
- death.
- Patients who are eligible for diagnosis/evaluation to chest CT scan and related to it
- Patients should be able to understand the essence of the clinical trial and to submit a written consent document. For the patients who can understand the nature of the research but cannot sign the document, a relative can agree to the study.
Who cannot join
- Patients who have a record of HIV or AIDS
- Female patients, either who are pregnant within 6 months before the investigation, who breast-fed babies within 3 months before the investigation, or who may get pregnant or breast-feed within 1 month after the investigation is over
- Patients at high risk of death within 3 days of randomized assignment, by the judge of the investigator
- Patients with liver cirrhosis whose Child-Puch score is B or C
- Patients who have liver disease abnormalities with ALT or AST > 5 times ULN
- Patients who can be in danger or who shows clinically-important other conditions which may interfere with the evaluation or completion of the test procedure, as the investigator's opinion
- Patients who are not appropriate for the test, as the investigator's opinion
- Patients who have hypersensitivity to the investigational drug
Trial locations and contacts
No sites are listed yet.
Kyunglan Moon, MD contact
About this study
Official title: Treatment Effect of Nafamostat Mesylate in Patients With COVID-19 Pneumonia: Open Labelled Randomized Controlled Clinical Trial
In-vitro studies revealed that nafamostat mesylate has antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and anti-inflammatory and anti-coagulation effect. However, there is no clinical studies on the efficacy of nafamostat in patients with COVID-19.
This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult patients hospitalized with COVID-19 pneumonia.
Read the detailed description
- The COVID-19 epidemic expanded to the whole world since it started from the Wuhan area in China in Dec. 2019. The Republic of Korea experiences a sharp increase in the patient since 24th Feb. 2020. An analysis of more than 70,000 patients in China, about 15% of them cause severe pneumonia, 5% require treatment in the intensive care unit, half of them die of the disease.
- There is no proven therapeutics for COVID-19 patients yet. Currently, the treatment with Kaletra, Hydroxychloroquine, etc. did not show apparent effect, and there are no other drugs that can apply to patients who get worse even with those drugs or severe.
- There are research reports that defective innate immunity and accelerated activation of the complement cascade, caused by the SARS-CoV-2, induce rapidly progressing pneumonitis.
- Action mechanism of Nafamostat mesilate A. Show anti-viral effect by an inhibition serine protease, which is required for the host membrane fusion of viral envelop protein. In vitro experiments showed that the drug is effective in MERS-CoV, Influenza virus, and SARS-CoV-2.
- Show anti-inflammatory effect by inhibition of the complement pathway, and inhibition of cytokine production.
This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult patients hospitalized with COVID-19 pneumonia.
- Conditions
- Corona Virus Infection, COVID-19
- Being tested
- Nafamostat Mesylate
- Keywords
- Nafamostat, Pneumonia, TMPSS2, Serine protease inhibitor
- Medical subject headings
- Coronavirus Infections, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nafamostat MesylateDrug
The Nafamostat mesilate group received continuous intravenous infusion of 0.1-0.2 mg/kg/h of nafamostat mesilate mixed with 5% DW.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | No intervention | The conventional therapy comprised, as necessary, Lopinavir/ritonavir, Hydroxychlorquine, supplemental oxygen, Non-invasive and invasive ventilation, antibiotic agents, renal-replacement therapy (e.g.: CRRT, HD), extracorporeal membrane oxygenation (ECMO). |
| Conventional therapy + Nafamostat mesylate | Experimental | * The conventional therapy comprised, as necessary, Lopinavir/ritonavir, Hydroxychlorquine, supplemental oxygen, Non-invasive and invasive ventilation, antibiotic agents, renal-replacement therapy (e.g.: CRRT, HD), extracorporeal membrane oxygenation (ECMO).
* Nafamostat mesylate injection day), taking into account the severity and underlying disease of the clinical trial patient.
* Method of administration: Nafamostat injection is mixed with 1,000 ml of 5% DW infusion, followed by continuous infusion over 24 hours.
* Duration of administration: The researcher administers for 10-14 days considering the severity and underlying disease of the clinical trial patient. Receives: Drug: Nafamostat Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with clinical improvement
Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status.
- Seven-category ordinal scale of clinical status
- not hospitalized with resumption of normal activities;
- not hospitalized, but unable to resume normal activities;
- hospitalization, not requiring supplemental oxygen;
- hospitalization, requiring supplemental oxygen;
- hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation;
- hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation;
- death.
Measured: Day 14 & Day 28
Secondary outcomes (16)
Time to clinical improvement (TTCI)
Time to clinical improvement (TTCI) was defined as time from randomization to a decline of 2 categories on the seven-category ordinal scale of clinical status or live discharge from the hospital, whichever came first.
Measured: up to 28 days
Clinical status assessed by 7-category ordinal scale
- Seven-category ordinal scale of clinical status
- not hospitalized with resumption of normal activities;
- not hospitalized, but unable to resume normal activities;
- hospitalization, not requiring supplemental oxygen;
- hospitalization, requiring supplemental oxygen;
- hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation;
- hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation;
- death.
- Higher scores of Seven-category ordinal scale mean serious clinical status.
Measured: days 7, 14, and 28
Change in National Early Warning Score (NEWS)
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The range of NEW score is from zero to 23. Higher scores of NEWS mean the higher risk of poor outcomes. The NEW Score is being used as an efficacy measure.
Measured: Day 1 trough Day 28
Time to National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours
Measured: Day 1 through Day 28
Duration of hospitalization
Measured: Day 1 through Day 28
Duration of new non-invasive ventilation or high flow oxygen use
Measured: Day 1 through Day 28
Incidence of new non-invasive ventilation or high flow oxygen use
Measured: Day 1 through Day 28
Duration of new supplement oxygen use
Measured: Day 1 through Day 28
Incidence of new supplement oxygen use
Measured: Day 1 through Day 28
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use
Measured: Day 1 through Day 28
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use
Measured: Day 1 through Day 28
Mortality at day 28
Measured: Day 1 through Day 28
Time (days) from treatment initiation to death
Measured: Day 1 through Day 28
Proportions of patients with a negative nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR
Measured: days 3, 7, 10, 14, and 21
Viral load change (log10 viral load) of nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR
Measured: days 3, 7, 10, 14, and 21
Adverse events that occurred during treatment
Measured: Day 1 through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start10 Jun 2020 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an open-labelled, randomized clinical trial to evaluate the efficacy of nafamostate in patients with COVID-19 pneumonia.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IN-GYU BAE, MD, Gyeongsang National University Hospital
- Investigators
- IN-GYU BAE, MD, Principal investigator, Gyeongsang National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418128
- Sponsor's protocol ID
- 2020-04-012
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5):e01753-18. doi: 10.1128/mBio.01753-18.
PubMed 30301856Yamaya M, Shimotai Y, Hatachi Y, Lusamba Kalonji N, Tando Y, Kitajima Y, Matsuo K, Kubo H, Nagatomi R, Hongo S, Homma M, Nishimura H. The serine protease inhibitor camostat inhibits influenza virus replication and cytokine production in primary cultures of human tracheal epithelial cells. Pulm Pharmacol Ther. 2015 Aug;33:66-74. doi: 10.1016/j.pupt.2015.07.001. Epub 2015 Jul 10.
PubMed 26166259Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
PubMed 32142651Hoffmann M, Schroeder S, Kleine-Weber H, Muller MA, Drosten C, Pohlmann S. Nafamostat Mesylate Blocks Activation of SARS-CoV-2: New Treatment Option for COVID-19. Antimicrob Agents Chemother. 2020 May 21;64(6):e00754-20. doi: 10.1128/AAC.00754-20. Print 2020 May 21. No abstract available.
PubMed 32312781Moon K, Hong KW, Bae IG. Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial. Trials. 2021 Nov 23;22(1):832. doi: 10.1186/s13063-021-05760-1.
PubMed 34814935
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effect of Nafamostat Mesylate in Patients With COVID-19 Pneumonia: Open Labelled Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04418128
- Acronym / sponsor ID
- 2020-04-012
- Conditions
- Corona Virus Infection, COVID-19
- Keywords
- Nafamostat, Pneumonia, TMPSS2, Serine protease inhibitor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Study start
- 10 Jun 2020 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 5 Jun 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-vitro studies revealed that nafamostat mesylate has antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and anti-inflammatory and anti-coagulation effect. However, there is no clinical studies on the efficacy of nafamostat in patients with COVID-19.
This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult patients hospitalized with COVID-19 pneumonia.
Detailed description
- The COVID-19 epidemic expanded to the whole world since it started from the Wuhan area in China in Dec. 2019. The Republic of Korea experiences a sharp increase in the patient since 24th Feb. 2020. An analysis of more than 70,000 patients in China, about 15% of them cause severe pneumonia, 5% require treatment in the intensive care unit, half of them die of the disease.
- There is no proven therapeutics for COVID-19 patients yet. Currently, the treatment with Kaletra, Hydroxychloroquine, etc. did not show apparent effect, and there are no other drugs that can apply to patients who get worse even with those drugs or severe.
- There are research reports that defective innate immunity and accelerated activation of the complement cascade, caused by the SARS-CoV-2, induce rapidly progressing pneumonitis.
- Action mechanism of Nafamostat mesilate A. Show anti-viral effect by an inhibition serine protease, which is required for the host membrane fusion of viral envelop protein. In vitro experiments showed that the drug is effective in MERS-CoV, Influenza virus, and SARS-CoV-2.
- Show anti-inflammatory effect by inhibition of the complement pathway, and inhibition of cytokine production.
This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult patients hospitalized with COVID-19 pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an open-labelled, randomized clinical trial to evaluate the efficacy of nafamostate in patients with COVID-19 pneumonia.
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | No intervention | –The conventional therapy comprised, as necessary, Lopinavir/ritonavir, Hydroxychlorquine, supplemental oxygen, Non-invasive and invasive ventilation, antibiotic agents, renal-replacement therapy (e.g.: CRRT, HD), extracorporeal membrane oxygenation (ECMO). |
| Conventional therapy + Nafamostat mesylate | Experimental | Drug: Nafamostat Mesylate* The conventional therapy comprised, as necessary, Lopinavir/ritonavir, Hydroxychlorquine, supplemental oxygen, Non-invasive and invasive ventilation, antibiotic agents, renal-replacement therapy (e.g.: CRRT, HD), extracorporeal membrane oxygenation (ECMO). * Nafamostat mesylate injection day), taking into account the severity and underlying disease of the clinical trial patient. * Method of administration: Nafamostat injection is mixed with 1,000 ml of 5% DW infusion, followed by continuous infusion over 24 hours. * Duration of administration: The researcher administers for 10-14 days considering the severity and underlying disease of the clinical trial patient. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
Key exclusion criteria (8 listed)
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 |
|---|---|---|
| Nafamostat MesylateThe Nafamostat mesilate group received continuous intravenous infusion of 0.1-0.2 mg/kg/h of nafamostat mesilate mixed with 5% DW. | Drug | Conventional therapy + Nafamostat mesylate |
Primary outcome
Proportion of patients with clinical improvement
Time frame: Day 14 & Day 28
Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status. * Seven-category ordinal scale of clinical status 1. not hospitalized with resumption of normal activities; 2. not hospitalized, but unable to resume normal activities; 3. hospitalization, not requiring supplemental oxygen; 4. hospitalization, requiring supplemental oxygen; 5. hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6. hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 7. death.
16 secondary outcomes
Time to clinical improvement (TTCI)
Time frame: up to 28 days
Clinical status assessed by 7-category ordinal scale
Time frame: days 7, 14, and 28
Change in National Early Warning Score (NEWS)
Time frame: Day 1 trough Day 28
Time to National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours
Time frame: Day 1 through Day 28
Duration of hospitalization
Time frame: Day 1 through Day 28
Duration of new non-invasive ventilation or high flow oxygen use
Time frame: Day 1 through Day 28
Incidence of new non-invasive ventilation or high flow oxygen use
Time frame: Day 1 through Day 28
Duration of new supplement oxygen use
Time frame: Day 1 through Day 28
Incidence of new supplement oxygen use
Time frame: Day 1 through Day 28
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use
Time frame: Day 1 through Day 28
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use
Time frame: Day 1 through Day 28
Mortality at day 28
Time frame: Day 1 through Day 28
Time (days) from treatment initiation to death
Time frame: Day 1 through Day 28
Proportions of patients with a negative nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR
Time frame: days 3, 7, 10, 14, and 21
Viral load change (log10 viral load) of nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR
Time frame: days 3, 7, 10, 14, and 21
Adverse events that occurred during treatment
Time frame: Day 1 through Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 30301856Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5):e01753-18. doi: 10.1128/mBio.01753-18.
- Background: PubMed 26166259Yamaya M, Shimotai Y, Hatachi Y, Lusamba Kalonji N, Tando Y, Kitajima Y, Matsuo K, Kubo H, Nagatomi R, Hongo S, Homma M, Nishimura H. The serine protease inhibitor camostat inhibits influenza virus replication and cytokine production in primary cultures of human tracheal epithelial cells. Pulm Pharmacol Ther. 2015 Aug;33:66-74. doi: 10.1016/j.pupt.2015.07.001. Epub 2015 Jul 10.
- Results publication: PubMed 32142651Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
- Results publication: PubMed 32312781Hoffmann M, Schroeder S, Kleine-Weber H, Muller MA, Drosten C, Pohlmann S. Nafamostat Mesylate Blocks Activation of SARS-CoV-2: New Treatment Option for COVID-19. Antimicrob Agents Chemother. 2020 May 21;64(6):e00754-20. doi: 10.1128/AAC.00754-20. Print 2020 May 21. No abstract available.
- Derived from this study: PubMed 34814935Moon K, Hong KW, Bae IG. Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial. Trials. 2021 Nov 23;22(1):832. doi: 10.1186/s13063-021-05760-1.
- 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.
Kyunglan Moon, MD contact
IN-GYU BAE, MD principal investigator
Gyeongsang National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nafamostat Mesylate in people with Corona Virus Infection and COVID-19, run by Gyeongsang National University Hospital.
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 16 inclusion and 8 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 9 Jun 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 IN-GYU BAE, MD (+82-55-750-8055, ttezebae@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with clinical improvement (time frame: Day 14 & Day 28). 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 NCT04418128, which also lists 5 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 9 Jun 2020.