Snake BitesPMSNCT06615960
Safety and Effectiveness of PANAF-Premium TM Snake Venom Antiserum As Standard Treatment for Snakebites
An observational study of Snake Bites, run by Premium Serums & Vaccines Pvt.Ltd. at 1 site in Cameroon.
Trial summary
Snakebite envenomation (SBE) is a major public health problem in many developing countries. Standard snake antivenom (SA) remains the primary treatment and has been shown to reduce mortality in observational studies conducted in several sub-Saharan African (SSA) countries. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Snake Bites
- How many people
- 112 participants
- Where
- 1 siteCameroon
- Study dates
- 26 Aug 2024to Apr 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will recruit participants with a history of snakebites or unknown bites showing signs of envenomation requiring Snake Antiserum. Participants will come from health districts in Mayo Oulo, Gashiga, Poli, and Garoua I, located in the North region of Cameroon. One facility in each district has been selected based on prior snakebite cases: Garoua Regional Hospital, Poli District Hospital, Mayo Oulo District Hospital, and Gashiga District Hospital. No specific gender ratio is required, as previous studies have shown no differences in treatment effectiveness or safety between genders.
Who may be able to join
- Patients of both sex and of any age, with history of snakebites/unknown bites received in study sites
- Willingness to participate in the study by signing the Informed Consent Form (ICF)
- Presence of one or more signs of envenomation detected by clinical examination including positive clot test. Patient may present with one or more of following visible clinical signs and symptoms of snake envenomation being local or systemic -
- Defining local and systemic envenomation
- Local envenomation- (I) Presence of bite marks with or without oozing of blood, blistering and change in color of skin.
- Rapidly progressive or massive swelling involving more than half of the bitten limb within few hours of bite (without tourniquet) (iii) Development of enlarged tender lymph nodes draining the bitten part within couple of hours after bite
- Systemic envenomation- (i) Neurotoxic syndrome- signs of neuro-paralysis like blurring of vision, double vision, difficulty in swallowing, sleepy feeling, drooping of head, slurring of speech and the voice may become indistinct with shallow breathing, ptosis, ataxia, respiratory paralysis and generalized flaccid paralysis.
- Hemotoxic syndrome- spontaneous systemic bleeding, nausea, vomiting, abdominal pain and abdominal tenderness suggestive of gastro-intestinal or retro-peritoneal bleed and/or renal damage, coagulopathy detected by 20 min WBCT with or without external bleeding and shock and a clinical condition/envenomation serious enough to administer SA will be eligible for enrolment
Who cannot join
- Participants not able to give consent
- Participants who are unable to understand the nature, scope, significance and consequences of this clinical trial
- Pre-existing renal disease, uncontrolled chronic obstructive airway disease, congestive heart failure or previous myocardial infarction and consumption of diuretics, anticoagulants and antiplatelet drugs have been causes for exclusion in a few earlier studies as these illnesses and medications could have altered the clinical and laboratory profile of patients with envenomation.
- Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
- Simultaneous participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
- Participants with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial
- Known or persistent abuse of medication, drugs or alcohol Others conditions may include evidence of clinically significant neurological, cardiac, pulmonary, hepatic or renal disease as far as can be assessed by history of participants, physical examination, and/or laboratory examinations.
- NB: Patient previously sensitized with equine antiserum such as Tetanus or Diphtheria antitoxin or patients having received treatment with adrenaline, antihistamine, or steroids as a part of treatment at primary health care center and pregnancy will not be excluded. Since this is a post-marketing study, these patients will be included, and this information will be factored in while collating and analyzing data.
Trial locations and contacts
1 site in 1 country.
Cameroon1 site, 1 recruiting
- Recruiting
Garoua Regional Hospital
Garoua, North Region
Tatiana Djikeussi, +237655190562, chokokamfile@gmail.com
Lorraine Guedem, +237693374545, neklorraine2@gmail.com
About this study
Official title: The Safety and Effectiveness of PANAF- Premium TM Snake Venom Antiserum-Pan Africa Administered As a Standard Treatment for Cases of Snakebites- a Phase IV Open Label Trial
Snakebite envenomation (SBE) is a major public health problem in many developing countries. Standard snake antivenom (SA) remains the primary treatment and has been shown to reduce mortality in observational studies conducted in several sub-Saharan African (SSA) countries. Although it is relatively available in other endemic contexts such as Asia and Latin America, there have been major challenges with the reliable supply of effective products in sub-Saharan Africa for many years. Premium Serums \& Vaccines Pvt. Ltd. (PSVPL) recently introduced its SA brand, namely PANAF-Premium TM, manufactured to address unmet treatment needs in the local context. This serum has received WHO approval for use in sub-Saharan Africa and is used in Cameroon with neutralizing efficacy for 24 species represented in Africa.
This is an open-label, Phase IV post-marketing surveillance study to collect safety and effectiveness data systematically following the administration of PANAF-Premium TM. The study will describe the types, severity, and number of adverse events recorded following the administration of PANAF-Premium TM and its effectiveness for snakebite management. Epidemiological data will also be collected, along with information on the snake species typically responsible for bites in the North region of Cameroon, the type of envenomation, the total dose of SA required for reversal of envenomation, and the total time required for clinical recovery. This will complement the international and national pool of pharmacovigilance data.
Read the detailed description
Background: Snakebite envenomation (SBE) is a major public health problem in many developing countries. Conventional snake antivenom (SA) remains the primary treatment and has been shown to reduce mortality in observational studies conducted in several sub-Saharan African (SSA) countries. Although it is relatively available in other endemic contexts such as Asia and Latin America, there have been major challenges with the reliable supply of effective products in sub-Saharan Africa for many years. Premium Serums \& Vaccines Pvt. Ltd. (PSVPL) recently introduced its SA brand, namely PANAF-Premium TM, manufactured to the latest standards, providing a solution to address unmet treatment needs in the local context. This serum has received WHO approval for use in sub-Saharan Africa and is used in Cameroon with neutralizing efficacy for 24 species represented in Africa. Since antivenom is of animal origin, it can cause adverse reactions ranging from mild itching to fatal anaphylaxis; therefore, patients should be treated appropriately or given prophylactic premedication. Approximately 20% of cases may develop early (within a few hours) or late (five days or more) allergic reactions after administration of snake antivenom. This open-label, Phase IV post-marketing surveillance study aims to collect safety and effectiveness data systematically following administration of PANAF-Premium TM. The study will describe the types, severity, and number of adverse events recorded following administration of PANAF-Premium TM and its effectiveness for snakebite management. Additionally, epidemiological data will be collected regarding the snake species typically responsible for bites in the North Cameroon region, the type of envenomation, the total dose of SA required for reversal of envenomation, and the total time required for clinical recovery. This will also contribute to the international and national pool of pharmacovigilance data.
Method: An open-label, Phase IV post-marketing surveillance trial will be conducted to describe the types, severity, and number of adverse events recorded during snakebite management. The average dose of SA used will be identified, and the duration of recovery, as well as the type of snakes prevalent in the area, will be explored. Eligible patients will be admitted to the hospital, and case management will be in accordance with the standard protocol followed in Cameroon and adapted from the guidelines of the African Society of Venomology. Any medication or procedure necessary to save the patient will be permitted. If antivenom serum is needed, the study drug to be used is PANAF-Premium TM (Snake Venom Antiserum-Pan Africa), manufactured by Premium Serums \& Vaccines Pvt. Ltd. Any suspicious or unexpected serious adverse events (SAEs) will be recorded immediately and reported to the sponsor/ethics committee for further action. There will be no restrictions on the use of any concomitant medication or other interventions or investigations mandated by the patient\'s clinical condition.
- Conditions
- Snake Bites
- Medical subject headings
- Snake Bites
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Panaf Premuim
Measured by the frequency and severity of the recorded Adverse events based on clinical evaluation using DAAD (Division of AIDS grading of AE) grading classification.
Measured: 30 days
Safety of Panaf Premium
Measured by the factors associated with the occurrence of adverse events, assessed through clinical evaluation and review of concomitant medication.
Measured: 30 days
Effectiveness of Panaf Premium
Measured by the number of days required to control toxicity, defined as the time in days to achieve reversal of a positive Whole Blood Clotting Test (WBCT) in cases of hemotoxic envenomation, and/or the time to reverse clinical signs and symptoms based on the African Society of Venimology's classification and grading of envenomation.
Measured: 30 days
Effectiveness of Panaf Premium
Effectiveness will be measured by the average dose of snake antivenom administered and documented throughout the patient\'s follow-up, with complete recovery defined by the resolution of symptoms according to the African Society of Venimology\'s classification and grading system
Measured: 30 days
Secondary outcomes (2)
Identification of Snake Species Responsible for Envenomation
This outcome will be assessed by identifying the snake species responsible for envenomation, based on the description provided by the patient, clinical evaluation, and, where available or laboratory analysis. The investigator will document the snake species involved using classification systems as per guidelines of the African Society of Venimology
Measured: 6 months
Snake bite epidemiology
This outcome will be assessed by calculating the proportion of patients who present with envenomation, categorized by age, sex, and clinical syndrome (e.g., neurotoxic, hemotoxic, or cytotoxic). Data will be collected using patient demographic information, clinical assessments, and envenomation classification systems based on the African Society of Venimology guidelines.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start26 Aug 2024
- Primary completion26 Feb 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Snake BitesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Premium Serums & Vaccines Pvt.Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khadillar, Study director, Premuim serums
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615960
- Sponsor's protocol ID
- PMS1001
- Acronym
- PMS
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This has not yet been decided for the moment
Publications
Gutierrez JM, Calvete JJ, Habib AG, Harrison RA, Williams DJ, Warrell DA. Snakebite envenoming. Nat Rev Dis Primers. 2017 Sep 14;3:17063. doi: 10.1038/nrdp.2017.63.
PubMed 28905944Visser LE, Kyei-Faried S, Belcher DW. Protocol and monitoring to improve snake bite outcomes in rural Ghana. Trans R Soc Trop Med Hyg. 2004 May;98(5):278-83. doi: 10.1016/S0035-9203(03)00065-8.
PubMed 15109550Schiermeier Q. Africa braced for snakebite crisis. Nature. 2015 Sep 17;525(7569):299. doi: 10.1038/525299a. No abstract available.
PubMed 26381961Chippaux JP, Habib AG. Antivenom shortage is not circumstantial but structural. Trans R Soc Trop Med Hyg. 2015 Dec;109(12):747-8. doi: 10.1093/trstmh/trv088. No abstract available.
PubMed 26626337Brown NI. Consequences of neglect: analysis of the sub-Saharan African snake antivenom market and the global context. PLoS Negl Trop Dis. 2012;6(6):e1670. doi: 10.1371/journal.pntd.0001670. Epub 2012 Jun 5.
PubMed 22679521Gutierrez JM. Global Availability of Antivenoms: The Relevance of Public Manufacturing Laboratories. Toxins (Basel). 2018 Dec 24;11(1):5. doi: 10.3390/toxins11010005.
PubMed 30586868Potet J, Smith J, McIver L. Reviewing evidence of the clinical effectiveness of commercially available antivenoms in sub-Saharan Africa identifies the need for a multi-centre, multi-antivenom clinical trial. PLoS Negl Trop Dis. 2019 Jun 24;13(6):e0007551. doi: 10.1371/journal.pntd.0007551. eCollection 2019 Jun.
PubMed 31233536Habib AG, Warrell DA. Antivenom therapy of carpet viper (Echis ocellatus) envenoming: effectiveness and strategies for delivery in West Africa. Toxicon. 2013 Jul;69:82-9. doi: 10.1016/j.toxicon.2013.01.002. Epub 2013 Jan 20.
PubMed 23339853
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of PANAF- Premium TM Snake Venom Antiserum-Pan Africa Administered As a Standard Treatment for Cases of Snakebites- a Phase IV Open Label Trial
- ClinicalTrials.gov ID
- NCT06615960
- Acronym / sponsor ID
- PMS / PMS1001
- Conditions
- Snake Bites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Premium Serums & Vaccines Pvt.Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 26 Feb 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 27 Sep 2024 (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.
Snakebite envenomation (SBE) is a major public health problem in many developing countries. Standard snake antivenom (SA) remains the primary treatment and has been shown to reduce mortality in observational studies conducted in several sub-Saharan African (SSA) countries. Although it is relatively available in other endemic contexts such as Asia and Latin America, there have been major challenges with the reliable supply of effective products in sub-Saharan Africa for many years. Premium Serums \& Vaccines Pvt. Ltd. (PSVPL) recently introduced its SA brand, namely PANAF-Premium TM, manufactured to address unmet treatment needs in the local context. This serum has received WHO approval for use in sub-Saharan Africa and is used in Cameroon with neutralizing efficacy for 24 species represented in Africa.
This is an open-label, Phase IV post-marketing surveillance study to collect safety and effectiveness data systematically following the administration of PANAF-Premium TM. The study will describe the types, severity, and number of adverse events recorded following the administration of PANAF-Premium TM and its effectiveness for snakebite management. Epidemiological data will also be collected, along with information on the snake species typically responsible for bites in the North region of Cameroon, the type of envenomation, the total dose of SA required for reversal of envenomation, and the total time required for clinical recovery. This will complement the international and national pool of pharmacovigilance data.
Detailed description
Background: Snakebite envenomation (SBE) is a major public health problem in many developing countries. Conventional snake antivenom (SA) remains the primary treatment and has been shown to reduce mortality in observational studies conducted in several sub-Saharan African (SSA) countries. Although it is relatively available in other endemic contexts such as Asia and Latin America, there have been major challenges with the reliable supply of effective products in sub-Saharan Africa for many years. Premium Serums \& Vaccines Pvt. Ltd. (PSVPL) recently introduced its SA brand, namely PANAF-Premium TM, manufactured to the latest standards, providing a solution to address unmet treatment needs in the local context. This serum has received WHO approval for use in sub-Saharan Africa and is used in Cameroon with neutralizing efficacy for 24 species represented in Africa. Since antivenom is of animal origin, it can cause adverse reactions ranging from mild itching to fatal anaphylaxis; therefore, patients should be treated appropriately or given prophylactic premedication. Approximately 20% of cases may develop early (within a few hours) or late (five days or more) allergic reactions after administration of snake antivenom. This open-label, Phase IV post-marketing surveillance study aims to collect safety and effectiveness data systematically following administration of PANAF-Premium TM. The study will describe the types, severity, and number of adverse events recorded following administration of PANAF-Premium TM and its effectiveness for snakebite management. Additionally, epidemiological data will be collected regarding the snake species typically responsible for bites in the North Cameroon region, the type of envenomation, the total dose of SA required for reversal of envenomation, and the total time required for clinical recovery. This will also contribute to the international and national pool of pharmacovigilance data.
Method: An open-label, Phase IV post-marketing surveillance trial will be conducted to describe the types, severity, and number of adverse events recorded during snakebite management. The average dose of SA used will be identified, and the duration of recovery, as well as the type of snakes prevalent in the area, will be explored. Eligible patients will be admitted to the hospital, and case management will be in accordance with the standard protocol followed in Cameroon and adapted from the guidelines of the African Society of Venomology. Any medication or procedure necessary to save the patient will be permitted. If antivenom serum is needed, the study drug to be used is PANAF-Premium TM (Snake Venom Antiserum-Pan Africa), manufactured by Premium Serums \& Vaccines Pvt. Ltd. Any suspicious or unexpected serious adverse events (SAEs) will be recorded immediately and reported to the sponsor/ethics committee for further action. There will be no restrictions on the use of any concomitant medication or other interventions or investigations mandated by the patient\'s clinical condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will recruit participants with a history of snakebites or unknown bites showing signs of envenomation requiring Snake Antiserum. Participants will come from health districts in Mayo Oulo, Gashiga, Poli, and Garoua I, located in the North region of Cameroon. One facility in each district has been selected based on prior snakebite cases: Garoua Regional Hospital, Poli District Hospital, Mayo Oulo District Hospital, and Gashiga District Hospital. No specific gender ratio is required, as previous studies have shown no differences in treatment effectiveness or safety between genders.
Key inclusion criteria (8 listed)
- Patients of both sex and of any age, with history of snakebites/unknown bites received in study sites
- Willingness to participate in the study by signing the Informed Consent Form (ICF)
- Presence of one or more signs of envenomation detected by clinical examination including positive clot test. Patient may present with one or more of following visible clinical signs and symptoms of snake envenomation being local or systemic -
- Defining local and systemic envenomation
- Local envenomation- (I) Presence of bite marks with or without oozing of blood, blistering and change in color of skin.
Key exclusion criteria (8 listed)
- Participants not able to give consent
- Participants who are unable to understand the nature, scope, significance and consequences of this clinical trial
- Pre-existing renal disease, uncontrolled chronic obstructive airway disease, congestive heart failure or previous myocardial infarction and consumption of diuretics, anticoagulants and antiplatelet drugs have been causes for exclusion in a few earlier studies as these illnesses and medications could have altered the clinical and laboratory profile of patients with envenomation.
- Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
- Simultaneous participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of Panaf Premuim
Time frame: 30 days
Measured by the frequency and severity of the recorded Adverse events based on clinical evaluation using DAAD (Division of AIDS grading of AE) grading classification.
Safety of Panaf Premium
Time frame: 30 days
Measured by the factors associated with the occurrence of adverse events, assessed through clinical evaluation and review of concomitant medication.
Effectiveness of Panaf Premium
Time frame: 30 days
Measured by the number of days required to control toxicity, defined as the time in days to achieve reversal of a positive Whole Blood Clotting Test (WBCT) in cases of hemotoxic envenomation, and/or the time to reverse clinical signs and symptoms based on the African Society of Venimology's classification and grading of envenomation.
Effectiveness of Panaf Premium
Time frame: 30 days
Effectiveness will be measured by the average dose of snake antivenom administered and documented throughout the patient\'s follow-up, with complete recovery defined by the resolution of symptoms according to the African Society of Venimology\'s classification and grading system
2 secondary outcomes
Identification of Snake Species Responsible for Envenomation
Time frame: 6 months
Snake bite epidemiology
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Background: PubMed 28905944Gutierrez JM, Calvete JJ, Habib AG, Harrison RA, Williams DJ, Warrell DA. Snakebite envenoming. Nat Rev Dis Primers. 2017 Sep 14;3:17063. doi: 10.1038/nrdp.2017.63.
- Background: PubMed 15109550Visser LE, Kyei-Faried S, Belcher DW. Protocol and monitoring to improve snake bite outcomes in rural Ghana. Trans R Soc Trop Med Hyg. 2004 May;98(5):278-83. doi: 10.1016/S0035-9203(03)00065-8.
- Background: PubMed 26381961Schiermeier Q. Africa braced for snakebite crisis. Nature. 2015 Sep 17;525(7569):299. doi: 10.1038/525299a. No abstract available.
- Background: PubMed 26626337Chippaux JP, Habib AG. Antivenom shortage is not circumstantial but structural. Trans R Soc Trop Med Hyg. 2015 Dec;109(12):747-8. doi: 10.1093/trstmh/trv088. No abstract available.
- Background: PubMed 22679521Brown NI. Consequences of neglect: analysis of the sub-Saharan African snake antivenom market and the global context. PLoS Negl Trop Dis. 2012;6(6):e1670. doi: 10.1371/journal.pntd.0001670. Epub 2012 Jun 5.
- Background: PubMed 30586868Gutierrez JM. Global Availability of Antivenoms: The Relevance of Public Manufacturing Laboratories. Toxins (Basel). 2018 Dec 24;11(1):5. doi: 10.3390/toxins11010005.
- Background: PubMed 31233536Potet J, Smith J, McIver L. Reviewing evidence of the clinical effectiveness of commercially available antivenoms in sub-Saharan Africa identifies the need for a multi-centre, multi-antivenom clinical trial. PLoS Negl Trop Dis. 2019 Jun 24;13(6):e0007551. doi: 10.1371/journal.pntd.0007551. eCollection 2019 Jun.
- Background: PubMed 23339853Habib AG, Warrell DA. Antivenom therapy of carpet viper (Echis ocellatus) envenoming: effectiveness and strategies for delivery in West Africa. Toxicon. 2013 Jul;69:82-9. doi: 10.1016/j.toxicon.2013.01.002. Epub 2013 Jan 20.
- Individual participant dataSharing planned: Undecided. This has not yet been decided for the moment
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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.
Khadillar study director
Premuim serums
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Snake Bites, run by Premium Serums & Vaccines Pvt.Ltd. at 1 site in Cameroon.
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 8 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 27 Sep 2024. 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 Cameroon. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Djikeussi (+237655190562, chokokamfile@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Panaf Premuim (time frame: 30 days). The study lists 4 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 NCT06615960, which also lists 8 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 Sep 2024.