Covid19Phase 2CombiVacSNCT05378191
Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose
A Phase 2 study testing COMIRNATY in people with Covid19, run by Instituto de Investigación Hospital Universitario La Paz at 5 sites in Spain.
Trial summary
CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the following factors: study site, sex and age. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- COMIRNATY
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesSpain
- Study dates
- 22 Apr 2021to 30 Dec 2022
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult subjects (18 years old) having received a prime VAXZEVRIA vaccination between 8 and 12 weeks before the screening visit
- Participants must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study.
- Subjects in good health or stable clinical situation.
- Participant is willing and able to adhere to the procedures specified in this protocol.
Who cannot join
- Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC within 24 hours prior to the planned dose of study vaccine.
- Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to COMIRNATY excipients.
- Subjects with any contraindication to the administration of COMIRNATY, included pregnancy.
- Subjects with prior documented COVID19 since VAXZEVRIA vaccination.
- Subjects have symptoms or signs compatible with COVID19.
- Subjects participating in a clinical trial in the last three months.
- Any condition or situation precluding or interfering the compliance with the protocol.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Hospital Vall d´Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
About this study
Official title: A Phase 2, Comparative, Randomised, Adaptive Trial to Evaluate the Safety and Immunogenicity of One Dose of Comirnaty® in Subjects That Had Received One Dose of Vaxzevria®
CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the following factors: study site, sex and age. This protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of VAXZEVRIA.
Read the detailed description
This is a randomized, non-blinded, controlled, adaptive, multicenter, Phase II study in subjects aged ≥18 years and in good health or stable clinical situation that have received a previous single dose of VAXZEVRIA. Subjects will be randomized to immediately receive or not a dose of COMIRNATY in a ratio of 2:1. If primary analysis at day 14th confirms the starting hypothesis, subjects randomized to no vaccination will be considered for administration of one dose of COMINARTY at day 28th according to Public Health Department of the Ministry of Health recommendations on heterologous vaccination. In case the primary analysis does not confirm the starting hypothesis, subjects will be followed at the time points defined in the flow-chart without administration of COMIRNATY.
Other heterologous vaccination strategies could be incorporated if deemed necessary for public health reasons. This could include the use of different vaccination strategies including those already marketed vaccines for comparative assessment of their safety and efficacy on SARS-CoV-2 and its variants.
- Conditions
- Covid19
- Being tested
- COMIRNATY
- Keywords
- heterologous vaccination
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMIRNATYDrug
Also called COVID-19, mRNA vaccine
One dose of COMIRNATY
| Study group | Role | What they receive |
|---|---|---|
| VACCINATION | Active comparator | One standard dose of COMIRNATY in adult subjects (18 years old) having received prior VAXZEVRIA vaccination. Receives: Drug: COMIRNATY |
| NO INTERVENTION | No intervention | No vaccination in adult subjects (18 years old) having received prior VAXZEVRIA vaccination. If primary analysis at day 14th confirms the starting hypothesis, subjects randomized to this arm will be considered for administration of one dose of COMINARTY at day 28th according to Public Health Department of the Ministry of Health recommendations on heterologous vaccination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the humoral immune response against SARS-CoV-2, 14 days after vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA, as compared with no dosing.
Antibodies against SARS-CoV-2 spike protein. Measure: BAU/mL
Measured: 14 days after randomization
Secondary outcomes (7)
To assess the humoral immune response against SARS-CoV-2, 28 days after vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA.
Antibodies against SARS-CoV-2 spike protein. Measure: BAU/mL
Measured: 28 days after randomization
To assess the long-term (up to 1 year) humoral immune response against SARS-CoV-2 of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA.
Antibodies against SARS-CoV-2 spike protein (BAU/mL)
Measured: 3, 6 and 12 months after randomization
To assess the occurrence of symptomatic molecularly confirmed COVID-19 and severity of COVID-19 signs and symptoms after the administration of a dose of COMIRNATY in subjects that received a prior single dose of VAXZEVRIA.
Number of participants with molecularly confirmed COVID-19 and presence and severity of COVID-19 signs and symptoms as measured by Symptoms of Infection with Coronavirus-19
Measured: Month 1 - 12
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (solicited adverse events)
Number of solicited local and systemic adverse events (AEs) for 7 days after vaccine
Measured: Day 1-7
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (unsolicited adverse events)
Number of unsolicited local and systemic adverse events (AEs) for 28 days after vaccine
Measured: Day 1-28
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (serious adverse events)
Number of Serious adverse events (SAEs) throughout the study (from randomization until end of the study).
Measured: Month 1-12
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (Medically-attended adverse events)
Number of Medically-attended adverse events (MAAEs) from the day of vaccination until 6 months after the last vaccination
Measured: Month 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start22 Apr 2021
- Primary completion22 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to immediately receive or not a dose of COMIRNATY in a ratio of 2:1. If primary analysis at 14 days confirms the starting hypothesis, subjects randomized to no vaccination will be considered for administration of one dose of COMINARTY at day 28th according to Public Health Department of the Ministry of Health recommendations on heterologous vaccination.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
- Investigators
- Cristobal Belda Iniesta, MD, PhD, Study chair, Instituto de Salud Carlos IIIJesús Frías Iniesta, MD, PhD, Principal investigator, Spanish Clinical Research Network - SCReNJose R Arribas, MD, PhD, Study director, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378191
- Sponsor's protocol ID
- 5859
- Acronym
- CombiVacS
- Status last verified
- May 2022
- First submitted
- 21 Sep 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will submit data to European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) and share data result.
Publications
Garcia-Perez J, Borobia AM, Perez-Olmeda M, Portoles A, Castano L, Campins-Arti M, Bertran MJ, Bermejo M, Arribas JR, Lopez A, Ascaso-Del-Rio A, Arana-Arri E, Fuentes Camps I, Vilella A, Cascajero A, Garcia-Morales MT, Castillo de la Osa M, Perez Ingidua C, Lora D, Jimenez-Santana P, Pino-Rosa S, Gomez de la Camara A, De La Torre-Tarazona E, Calonge E, Cruces R, Belda-Iniesta C, Alcami J, Frias J, Carcas AJ, Diez-Fuertes F; CombiVacS Study Group. Immunogenicity of a third dose with mRNA-vaccines in the ChAdOx1-S/BNT162b2 vaccination regimen against SARS-CoV-2 variants. iScience. 2024 Aug 14;27(9):110728. doi: 10.1016/j.isci.2024.110728. eCollection 2024 Sep 20.
PubMed 39286494Garcia-Perez J, Gonzalez-Perez M, Castillo de la Osa M, Borobia AM, Castano L, Bertran MJ, Campins M, Portoles A, Lora D, Bermejo M, Conde P, Hernandez-Gutierrez L, Carcas A, Arana-Arri E, Tortajada M, Fuentes I, Ascaso A, Garcia-Morales MT, Erick de la Torre-Tarazona H, Arribas JR, Imaz-Ayo N, Mellado-Pau E, Agusti A, Perez-Ingidua C, Gomez de la Camara A, Ochando J, Belda-Iniesta C, Frias J, Alcami J, Perez-Olmeda M; CombiVacS study Group. Immunogenic dynamics and SARS-CoV-2 variant neutralisation of the heterologous ChAdOx1-S/BNT162b2 vaccination: Secondary analysis of the randomised CombiVacS study. EClinicalMedicine. 2022 Jul 1;50:101529. doi: 10.1016/j.eclinm.2022.101529. eCollection 2022 Aug.
PubMed 35795713Borobia AM, Carcas AJ, Perez-Olmeda M, Castano L, Bertran MJ, Garcia-Perez J, Campins M, Portoles A, Gonzalez-Perez M, Garcia Morales MT, Arana-Arri E, Aldea M, Diez-Fuertes F, Fuentes I, Ascaso A, Lora D, Imaz-Ayo N, Baron-Mira LE, Agusti A, Perez-Ingidua C, Gomez de la Camara A, Arribas JR, Ochando J, Alcami J, Belda-Iniesta C, Frias J; CombiVacS Study Group. Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet. 2021 Jul 10;398(10295):121-130. doi: 10.1016/S0140-6736(21)01420-3. Epub 2021 Jun 25.
PubMed 34181880
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Comparative, Randomised, Adaptive Trial to Evaluate the Safety and Immunogenicity of One Dose of Comirnaty® in Subjects That Had Received One Dose of Vaxzevria®
- ClinicalTrials.gov ID
- NCT05378191
- Acronym / sponsor ID
- CombiVacS / 5859
- Conditions
- Covid19
- Keywords
- heterologous vaccination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Spanish Clinical Research Network - SCReN
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 22 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 18 May 2022 (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.
CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the following factors: study site, sex and age. This protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of VAXZEVRIA.
Detailed description
This is a randomized, non-blinded, controlled, adaptive, multicenter, Phase II study in subjects aged ≥18 years and in good health or stable clinical situation that have received a previous single dose of VAXZEVRIA. Subjects will be randomized to immediately receive or not a dose of COMIRNATY in a ratio of 2:1. If primary analysis at day 14th confirms the starting hypothesis, subjects randomized to no vaccination will be considered for administration of one dose of COMINARTY at day 28th according to Public Health Department of the Ministry of Health recommendations on heterologous vaccination. In case the primary analysis does not confirm the starting hypothesis, subjects will be followed at the time points defined in the flow-chart without administration of COMIRNATY.
Other heterologous vaccination strategies could be incorporated if deemed necessary for public health reasons. This could include the use of different vaccination strategies including those already marketed vaccines for comparative assessment of their safety and efficacy on SARS-CoV-2 and its variants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized to immediately receive or not a dose of COMIRNATY in a ratio of 2:1. If primary analysis at 14 days confirms the starting hypothesis, subjects randomized to no vaccination will be considered for administration of one dose of COMINARTY at day 28th according to Public Health Department of the Ministry of Health recommendations on heterologous vaccination.
| Arm | Type | Receives |
|---|---|---|
| VACCINATION | Active comparator | Drug: COMIRNATYOne standard dose of COMIRNATY in adult subjects (18 years old) having received prior VAXZEVRIA vaccination. |
| NO INTERVENTION | No intervention | –No vaccination in adult subjects (18 years old) having received prior VAXZEVRIA vaccination. If primary analysis at day 14th confirms the starting hypothesis, subjects randomized to this arm will be considered for administration of one dose of COMINARTY at day 28th according to Public Health Department of the Ministry of Health recommendations on heterologous vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult subjects (18 years old) having received a prime VAXZEVRIA vaccination between 8 and 12 weeks before the screening visit
- Participants must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study.
- Subjects in good health or stable clinical situation.
- Participant is willing and able to adhere to the procedures specified in this protocol.
Key exclusion criteria (7 listed)
- Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC within 24 hours prior to the planned dose of study vaccine.
- Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to COMIRNATY excipients.
- Subjects with any contraindication to the administration of COMIRNATY, included pregnancy.
- Subjects with prior documented COVID19 since VAXZEVRIA vaccination.
- Subjects have symptoms or signs compatible with COVID19.
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 |
|---|---|---|
| COMIRNATYAlso: COVID-19, mRNA vaccineOne dose of COMIRNATY | Drug | VACCINATION |
Primary outcome
To assess the humoral immune response against SARS-CoV-2, 14 days after vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA, as compared with no dosing.
Time frame: 14 days after randomization
Antibodies against SARS-CoV-2 spike protein. Measure: BAU/mL
7 secondary outcomes
To assess the humoral immune response against SARS-CoV-2, 28 days after vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA.
Time frame: 28 days after randomization
To assess the long-term (up to 1 year) humoral immune response against SARS-CoV-2 of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA.
Time frame: 3, 6 and 12 months after randomization
To assess the occurrence of symptomatic molecularly confirmed COVID-19 and severity of COVID-19 signs and symptoms after the administration of a dose of COMIRNATY in subjects that received a prior single dose of VAXZEVRIA.
Time frame: Month 1 - 12
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (solicited adverse events)
Time frame: Day 1-7
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (unsolicited adverse events)
Time frame: Day 1-28
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (serious adverse events)
Time frame: Month 1-12
To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (Medically-attended adverse events)
Time frame: Month 1-6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 39286494Garcia-Perez J, Borobia AM, Perez-Olmeda M, Portoles A, Castano L, Campins-Arti M, Bertran MJ, Bermejo M, Arribas JR, Lopez A, Ascaso-Del-Rio A, Arana-Arri E, Fuentes Camps I, Vilella A, Cascajero A, Garcia-Morales MT, Castillo de la Osa M, Perez Ingidua C, Lora D, Jimenez-Santana P, Pino-Rosa S, Gomez de la Camara A, De La Torre-Tarazona E, Calonge E, Cruces R, Belda-Iniesta C, Alcami J, Frias J, Carcas AJ, Diez-Fuertes F; CombiVacS Study Group. Immunogenicity of a third dose with mRNA-vaccines in the ChAdOx1-S/BNT162b2 vaccination regimen against SARS-CoV-2 variants. iScience. 2024 Aug 14;27(9):110728. doi: 10.1016/j.isci.2024.110728. eCollection 2024 Sep 20.
- Derived from this study: PubMed 35795713Garcia-Perez J, Gonzalez-Perez M, Castillo de la Osa M, Borobia AM, Castano L, Bertran MJ, Campins M, Portoles A, Lora D, Bermejo M, Conde P, Hernandez-Gutierrez L, Carcas A, Arana-Arri E, Tortajada M, Fuentes I, Ascaso A, Garcia-Morales MT, Erick de la Torre-Tarazona H, Arribas JR, Imaz-Ayo N, Mellado-Pau E, Agusti A, Perez-Ingidua C, Gomez de la Camara A, Ochando J, Belda-Iniesta C, Frias J, Alcami J, Perez-Olmeda M; CombiVacS study Group. Immunogenic dynamics and SARS-CoV-2 variant neutralisation of the heterologous ChAdOx1-S/BNT162b2 vaccination: Secondary analysis of the randomised CombiVacS study. EClinicalMedicine. 2022 Jul 1;50:101529. doi: 10.1016/j.eclinm.2022.101529. eCollection 2022 Aug.
- Derived from this study: PubMed 34181880Borobia AM, Carcas AJ, Perez-Olmeda M, Castano L, Bertran MJ, Garcia-Perez J, Campins M, Portoles A, Gonzalez-Perez M, Garcia Morales MT, Arana-Arri E, Aldea M, Diez-Fuertes F, Fuentes I, Ascaso A, Lora D, Imaz-Ayo N, Baron-Mira LE, Agusti A, Perez-Ingidua C, Gomez de la Camara A, Arribas JR, Ochando J, Alcami J, Belda-Iniesta C, Frias J; CombiVacS Study Group. Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet. 2021 Jul 10;398(10295):121-130. doi: 10.1016/S0140-6736(21)01420-3. Epub 2021 Jun 25.
- Individual participant dataSharing planned: Yes. Will submit data to European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) and share data result.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Cristobal Belda Iniesta, MD, PhD study chair
Instituto de Salud Carlos III
Jesús Frías Iniesta, MD, PhD principal investigator
Spanish Clinical Research Network - SCReN
Jose R Arribas, MD, PhD study director
Hospital Universitario La Paz
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COMIRNATY in people with Covid19, run by Instituto de Investigación Hospital Universitario La Paz at 5 sites in Spain.
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 4 inclusion and 7 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 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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 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.
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?
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?
To assess the humoral immune response against SARS-CoV-2, 14 days after vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA, as compared with no dosing. (time frame: 14 days after randomization). 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 NCT05378191, which also lists 3 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 18 May 2022.