Ebola VirusPhase 2/3NCT03719586
Investigational Therapeutics for the Treatment of People With Ebola Virus Disease
A Phase 2/3 study testing ZMapp, Remdesivir and MAb114 in people with Ebola Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
Trial summary
Background: Ebola virus can cause serious illness or death. No medicines are approved to treat it. Researchers need to test new medicines to see if they help people recover from Ebola and are safe to give. They need to test the drugs and compare them in a controlled way. Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Ebola Virus
- What is being tested?
- ZMapp, Remdesivir and MAb114
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 681 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Nov 2018to 18 Aug 2020
- Phase
- Phase 2/3
- 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 Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males or females of any age with documented positive RT-PCR in blood for acute Ebola virus infection within 3 days prior to enrollment and who have symptoms of any duration.
- Willingness of study participant to accept randomization to any assigned treatment arm.
- All males and females of childbearing potential must be willing to use effective methods of contraception, from time of enrollment until Day 58 of study.
- Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.
- Ability to provide informed consent personally, or by a legally acceptable representative if the patient is unable to do so.
Who cannot join
- Patients who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through Day 28.
- Prior treatment with any investigational antiviral drug therapy against Ebola virus infection within 5 half-lives or 30 days, whichever is longer, prior to enrollment. (Patients who have received an experimental (or, in future, potentially a licensed) immunization against Ebola virus remain eligible.)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Democratic Republic of the Congo1 site
Ebola Treatment Centers throughout the DRC
Kinshasa Gombe
About this study
Official title: A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for the Treatment of Patients With Ebola Virus Disease
Background:
Ebola virus can cause serious illness or death. No medicines are approved to treat it. Researchers need to test new medicines to see if they help people recover from Ebola and are safe to give. They need to test the drugs and compare them in a controlled way. Researchers want to test 4 drugs with people who have Ebola and are in treatment centers.
Read more
Objective:
To study the safety and effectiveness of 4 drugs for people with Ebola virus.
Eligibility:
People of any age with Ebola infection who are in treatment centers
Design:
Participants will be screened with questions, medical history, and blood tests.
Participants will be randomly assigned to get 1 of 3 study drugs:
- ZMapp by IV over about 4 hours. It will be given 3 times, 3 days apart.
- Remdesivir by IV over about 1 hour. It will be given once a day for 10 days.
- Mab114 by IV for 30-60 minutes. It will be given 1 time.
- REGN-EB3 by IV for about 2 hours. It will be given 1 time.
For at least a week, participants will stay in isolation in a clinic. They will:
- Get supportive care and be monitored
- Have a small plastic tube (IV) put in an arm vein for several days to give fluids and collect blood.
- Get their study drug.
- Be monitored for disease signs and drug side effects. They may get medicines for side effects.
- Have blood and urine tests.
Participants will stay in the clinic until they finish the study drug and are well enough to leave.
Participants will have 2 follow-up visits over 2 months. They will answer questions and give blood and semen samples.
...
Read the detailed description
Species Zaire ebolaviruses (EBOV) are members of the Filoviridae and are known primarily as the underlying cause of severe viral hemorrhagic fevers with disturbingly high case fatality rates. Between 1994 and the present, there have been many filovirus outbreaks affecting mostly central Africa, with 2 large outbreaks in 1995 in Kikwit, Democratic Republic of Congo (DRC), and in Gulu, Uganda in 2000-2001. The 2013-2016 West African outbreak significantly exceeded all previous outbreaks in geographic range, number of patients affected, and in disruption of typical activities of civil society. In 2018 there have been two additional outbreaks of EBOV infection, both in the Democratic Republic of the Congo and constituting the 9th and 10th recorded outbreaks of this infection in that country. The 10th outbreak is currently ongoing in the DRC as of December 2018 and has raised great concern because of the potential to expand greatly in scope and to spread to surrounding regions.
It has been suggested that one of the most important elements necessary to improve survival from Ebola virus infection is the provision of supportive care inclusive of hemodynamic support in the form of aggressive fluid replacement, ability to diagnose and correct severe metabolic derangements, early treatment of sepsis, and other standards of modern medical care. A small number of investigational therapeutics have been developed as putative antiviral strategies for treating this infection. Unfortunately, phase 1/2 data supporting the safety and efficacy of these agents are often limited, and thus there remains some degree of equipoise as to which of these interventions should be prioritized in the treatment of severe infection. The triple monoclonal antibody product ZMapp was studied through a randomized controlled trial (RCT) in the 2014-2016 West African outbreak and remains perhaps the best characterized of the available investigational products, but the end of that outbreak forced the RCT to close prior to crossing pre-specified evidentiary boundaries.
A WHO Research and Development Ebola Therapeutics Committee has agreed that, given the lethality of Ebola virus and the combination of human and non-human primate (NHP) efficacy data for ZMapp, either ZMapp+oSOC or oSOC alone could potentially be positioned as the control arm in comparative trials depending upon the preferences of the host countries. The DRC has chosen to use ZMapp + oSOC in the current protocol. However, both the nature and number of control and invegstigational arms may change over the course of the trial. Such changes would require protocol amendments.
This multicenter, multi-outbreak, randomized controlled trial will study the comparative safety and efficacy of additional investigational therapeutics compared to ZMapp in patients with known EBOV disease (Zaire) receiving oSOC. The primary endpoint of this comparison will be mortality by Day 28, with a number of secondary endpoints also planned that should generate important knowledge about the safety, ease of administration, and antiviral activity of all of these investigational interventions.
- Conditions
- Ebola Virus
- Being tested
- ZMapp, Remdesivir, MAb114, REGN-EB3
- Keywords
- EBOV, Viral Hemorrhagic Fever, Ebola Treatment Center, Filovirus, Zaire Ebola Virus
- Medical subject headings
- Hemorrhagic Fevers, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZMappDrug
Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
RemdesivirDrug
Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg remdesivir 2.5 mg/kg)
MAb114Drug
50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
REGN-EB3Drug
150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Remdesivir plus optimized Standard of Care (oSOC) Receives: Drug: Remdesivir |
| B | Experimental | MAb114 plus optimized Standard of Care (oSOC) Receives: Drug: MAb114 |
| C | Experimental | REGN-EB3 plus optimized Standard of Care (oSOC) Receives: Drug: REGN-EB3 |
| Control | Experimental | Zmapp plus optimized Standard of Care (oSOC) Receives: Drug: ZMapp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of Participants with Mortality by Day 28
Measured: 28 days
Secondary outcomes (3)
Time in Days to First Negative Ebola Virus RT-PCR in Blood.
This was a measure of the median number of days that it took for the serum PCR to first turn negative after having been positive throughout the patient's earlier course.
Measured: up to Day 28
Viremia as Determined by CTnp Values on PCR
These are the median CTnp pCR values measured serially on the 4 treatment arms as per protocol.
caveats: Undetectable ctNP values are imputed as ctNP=45.0 (the limit of detection). Missing values (due to gaps in sample collection, discharge, or death) are handled by carrying forward the last observation.
The Day 28 visit includes a ±7-day visit window. The priority for defining the ctNP value for this timepoint, according to days post-randomization, is: 28, 27, 29, 26, 30, 25, 31, 24, 32, 23, 33, 22, 34, 21. For example, the ctNP result from the sample collected 26 days post-randomization will only be used for this timepoint if there are no sample results for 28, 27, or 29 days post-randomization.
Measured: Days 1, 2, 3, 4, 6, 8, 10, 14, and 28.
Incidence of Serious Adverse Events/AEs
The number of Serious Adverse Events that were tentatively ascribed to one of the four treatment arms by the site investigator and, upon extensive further review and adjudication by an independent Pharmacovigilance committee, were still felt potentially attributable to study drug as opposed to the underlying Ebola infection.
Measured: up to Day 58
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start21 Nov 2018
- Primary completion9 Sep 2019
- Study completion18 Aug 2020
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 (2)Papers the sponsor has linked to this study.
- Other trials for Ebola VirusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 681 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard T Davey, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719586
- Sponsor's protocol ID
- 190003
- Other IDs
- 19-I-0003
- Status last verified
- Nov 2020
- First submitted
- 24 Oct 2018
- Last updated
- 8 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ottoni MP, Ricciardone JD, Nadimpalli A, Singh S, Katsomya AM, Pokoso LM, Petrucci R. Ebola-negative neonates born to Ebola-infected mothers after monoclonal antibody therapy: a case series. Lancet Child Adolesc Health. 2020 Dec;4(12):884-888. doi: 10.1016/S2352-4642(20)30278-9.
PubMed 33217357Mulangu S, Dodd LE, Davey RT Jr, Tshiani Mbaya O, Proschan M, Mukadi D, Lusakibanza Manzo M, Nzolo D, Tshomba Oloma A, Ibanda A, Ali R, Coulibaly S, Levine AC, Grais R, Diaz J, Lane HC, Muyembe-Tamfum JJ; PALM Writing Group; Sivahera B, Camara M, Kojan R, Walker R, Dighero-Kemp B, Cao H, Mukumbayi P, Mbala-Kingebeni P, Ahuka S, Albert S, Bonnett T, Crozier I, Duvenhage M, Proffitt C, Teitelbaum M, Moench T, Aboulhab J, Barrett K, Cahill K, Cone K, Eckes R, Hensley L, Herpin B, Higgs E, Ledgerwood J, Pierson J, Smolskis M, Sow Y, Tierney J, Sivapalasingam S, Holman W, Gettinger N, Vallee D, Nordwall J; PALM Consortium Study Team. A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics. N Engl J Med. 2019 Dec 12;381(24):2293-2303. doi: 10.1056/NEJMoa1910993. Epub 2019 Nov 27.
PubMed 31774950
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for the Treatment of Patients With Ebola Virus Disease
- ClinicalTrials.gov ID
- NCT03719586
- Acronym / sponsor ID
- 190003
- Conditions
- Ebola Virus
- Keywords
- EBOV, Viral Hemorrhagic Fever, Ebola Treatment Center, Filovirus, Zaire Ebola Virus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 681 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Posted 8 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Ebola virus can cause serious illness or death. No medicines are approved to treat it. Researchers need to test new medicines to see if they help people recover from Ebola and are safe to give. They need to test the drugs and compare them in a controlled way. Researchers want to test 4 drugs with people who have Ebola and are in treatment centers.
Objective:
To study the safety and effectiveness of 4 drugs for people with Ebola virus.
Eligibility:
People of any age with Ebola infection who are in treatment centers
Design:
Participants will be screened with questions, medical history, and blood tests.
Participants will be randomly assigned to get 1 of 3 study drugs:
- ZMapp by IV over about 4 hours. It will be given 3 times, 3 days apart.
- Remdesivir by IV over about 1 hour. It will be given once a day for 10 days.
- Mab114 by IV for 30-60 minutes. It will be given 1 time.
- REGN-EB3 by IV for about 2 hours. It will be given 1 time.
For at least a week, participants will stay in isolation in a clinic. They will:
- Get supportive care and be monitored
- Have a small plastic tube (IV) put in an arm vein for several days to give fluids and collect blood.
- Get their study drug.
- Be monitored for disease signs and drug side effects. They may get medicines for side effects.
- Have blood and urine tests.
Participants will stay in the clinic until they finish the study drug and are well enough to leave.
Participants will have 2 follow-up visits over 2 months. They will answer questions and give blood and semen samples.
...
Detailed description
Species Zaire ebolaviruses (EBOV) are members of the Filoviridae and are known primarily as the underlying cause of severe viral hemorrhagic fevers with disturbingly high case fatality rates. Between 1994 and the present, there have been many filovirus outbreaks affecting mostly central Africa, with 2 large outbreaks in 1995 in Kikwit, Democratic Republic of Congo (DRC), and in Gulu, Uganda in 2000-2001. The 2013-2016 West African outbreak significantly exceeded all previous outbreaks in geographic range, number of patients affected, and in disruption of typical activities of civil society. In 2018 there have been two additional outbreaks of EBOV infection, both in the Democratic Republic of the Congo and constituting the 9th and 10th recorded outbreaks of this infection in that country. The 10th outbreak is currently ongoing in the DRC as of December 2018 and has raised great concern because of the potential to expand greatly in scope and to spread to surrounding regions.
It has been suggested that one of the most important elements necessary to improve survival from Ebola virus infection is the provision of supportive care inclusive of hemodynamic support in the form of aggressive fluid replacement, ability to diagnose and correct severe metabolic derangements, early treatment of sepsis, and other standards of modern medical care. A small number of investigational therapeutics have been developed as putative antiviral strategies for treating this infection. Unfortunately, phase 1/2 data supporting the safety and efficacy of these agents are often limited, and thus there remains some degree of equipoise as to which of these interventions should be prioritized in the treatment of severe infection. The triple monoclonal antibody product ZMapp was studied through a randomized controlled trial (RCT) in the 2014-2016 West African outbreak and remains perhaps the best characterized of the available investigational products, but the end of that outbreak forced the RCT to close prior to crossing pre-specified evidentiary boundaries.
A WHO Research and Development Ebola Therapeutics Committee has agreed that, given the lethality of Ebola virus and the combination of human and non-human primate (NHP) efficacy data for ZMapp, either ZMapp+oSOC or oSOC alone could potentially be positioned as the control arm in comparative trials depending upon the preferences of the host countries. The DRC has chosen to use ZMapp + oSOC in the current protocol. However, both the nature and number of control and invegstigational arms may change over the course of the trial. Such changes would require protocol amendments.
This multicenter, multi-outbreak, randomized controlled trial will study the comparative safety and efficacy of additional investigational therapeutics compared to ZMapp in patients with known EBOV disease (Zaire) receiving oSOC. The primary endpoint of this comparison will be mortality by Day 28, with a number of secondary endpoints also planned that should generate important knowledge about the safety, ease of administration, and antiviral activity of all of these investigational interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: RemdesivirRemdesivir plus optimized Standard of Care (oSOC) |
| B | Experimental | Drug: MAb114MAb114 plus optimized Standard of Care (oSOC) |
| C | Experimental | Drug: REGN-EB3REGN-EB3 plus optimized Standard of Care (oSOC) |
| Control | Experimental | Drug: ZMappZmapp plus optimized Standard of Care (oSOC) |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females of any age with documented positive RT-PCR in blood for acute Ebola virus infection within 3 days prior to enrollment and who have symptoms of any duration.
- Willingness of study participant to accept randomization to any assigned treatment arm.
- All males and females of childbearing potential must be willing to use effective methods of contraception, from time of enrollment until Day 58 of study.
- Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.
- Ability to provide informed consent personally, or by a legally acceptable representative if the patient is unable to do so.
Key exclusion criteria (2 listed)
- Patients who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through Day 28.
- Prior treatment with any investigational antiviral drug therapy against Ebola virus infection within 5 half-lives or 30 days, whichever is longer, prior to enrollment. (Patients who have received an experimental (or, in future, potentially a licensed) immunization against Ebola virus remain eligible.)
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 |
|---|---|---|
| ZMappThree doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1 | Drug | Control |
| RemdesivirAdministered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg remdesivir 2.5 mg/kg) | Drug | A |
| MAb11450 mg/kg of body weight administered intravenously on Day 1 as a single infusion | Drug | B |
| REGN-EB3150 mg/kg of body weight administered intravenously on Day 1 as a single infusion | Drug | C |
Primary outcome
Mortality
Time frame: 28 days
Number of Participants with Mortality by Day 28
3 secondary outcomes
Time in Days to First Negative Ebola Virus RT-PCR in Blood.
Time frame: up to Day 28
Viremia as Determined by CTnp Values on PCR
Time frame: Days 1, 2, 3, 4, 6, 8, 10, 14, and 28.
Incidence of Serious Adverse Events/AEs
Time frame: up to Day 58
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33217357Ottoni MP, Ricciardone JD, Nadimpalli A, Singh S, Katsomya AM, Pokoso LM, Petrucci R. Ebola-negative neonates born to Ebola-infected mothers after monoclonal antibody therapy: a case series. Lancet Child Adolesc Health. 2020 Dec;4(12):884-888. doi: 10.1016/S2352-4642(20)30278-9.
- Derived from this study: PubMed 31774950Mulangu S, Dodd LE, Davey RT Jr, Tshiani Mbaya O, Proschan M, Mukadi D, Lusakibanza Manzo M, Nzolo D, Tshomba Oloma A, Ibanda A, Ali R, Coulibaly S, Levine AC, Grais R, Diaz J, Lane HC, Muyembe-Tamfum JJ; PALM Writing Group; Sivahera B, Camara M, Kojan R, Walker R, Dighero-Kemp B, Cao H, Mukumbayi P, Mbala-Kingebeni P, Ahuka S, Albert S, Bonnett T, Crozier I, Duvenhage M, Proffitt C, Teitelbaum M, Moench T, Aboulhab J, Barrett K, Cahill K, Cone K, Eckes R, Hensley L, Herpin B, Higgs E, Ledgerwood J, Pierson J, Smolskis M, Sow Y, Tierney J, Sivapalasingam S, Holman W, Gettinger N, Vallee D, Nordwall J; PALM Consortium Study Team. A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics. N Engl J Med. 2019 Dec 12;381(24):2293-2303. doi: 10.1056/NEJMoa1910993. Epub 2019 Nov 27.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Richard T Davey, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ZMapp, Remdesivir and MAb114 in people with Ebola Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
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 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 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Democratic Republic of the Congo. 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 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?
Yes. Results are posted in the registry (first posted 8 Sep 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?
Mortality (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 NCT03719586, 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 8 Sep 2021.