COVID-19NCT05564884
Neonatal SARS-CoV-2 Anti-spike Protein Receptor-binding Domain Antibodies at Delivery
An observational study of COVID-19, run by Rabin Medical Center at 1 site in Israel.
Trial summary
To assess the association between neonatal SARS-CoV-2 antibody level at delivery and infant COVID-19 infection under age 6 months, and to identify predictive factors for neonatal antibody level at delivery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- COVID-19
- What is being tested?
- no intervantion
- Type of treatment
- Vaccines
- How many people
- 58 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Sep 2021to 1 Nov 2022
- How long will I take part?
- 6 Months
- 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
- Women only
- Child, Adult, Older adult
Study population: Mothers prior to transfer to the delivery room and followed at the Maternity and Infant Ward
Who may be able to join
- included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection
Who cannot join
- preterm birth at <34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association of Neonatal SARS-CoV-2 Anti-spike Protein Receptor-binding Domain Antibodies at Delivery With Infant COVID-19 Infection Under Age 6 Months: a Prospective Cohort Study
To assess the association between neonatal SARS-CoV-2 antibody level at delivery and infant COVID-19 infection under age 6 months, and to identify predictive factors for neonatal antibody level at delivery.
Read the detailed description
This prospective observational study was conducted at the Rabin Medical Center, Israel. Mothers were enrolled from September 2021 to mid-February 2022, prior to transfer to the delivery room, and followed at the Maternity and Infant Ward. The study was approved by the institutional ethics committee (RMC- 0275-21). Written informed consent was obtained from the participating mothers. Inclusion criteria included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection. Exclusion criteria included (a) preterm birth at <34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.
- Conditions
- COVID-19
- Being tested
- no intervantion
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervantionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Unvaccinated, Prior natural COVID-19 infection | Unvaccinated, Prior natural COVID-19 infection Receives: Other: no intervantion | |
| Vaccinated, No prior natural COVID-19 infection | Vaccinated, No prior natural COVID-19 infection Receives: Other: no intervantion | |
| Vaccinated, Prior natural COVID-19 infection | Vaccinated, Prior natural COVID-19 infection Receives: Other: no intervantion |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal anti-spike antibody levels
Primary outcomes were neonatal anti-spike antibody levels at delivery and infant microbiologically-confirmed COVID-19 infection at age <6 months
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 posted4 Oct 2022
- Study start12 Sep 2021
- Primary completion24 Feb 2022
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liat Ashkenazi-Hoffnung, Principal investigator, Schneider children medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564884
- Sponsor's protocol ID
- RMC-0275-21
- Status last verified
- Sep 2022
- First submitted
- 29 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to ethics committee approval.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Neonatal SARS-CoV-2 Anti-spike Protein Receptor-binding Domain Antibodies at Delivery With Infant COVID-19 Infection Under Age 6 Months: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05564884
- Acronym / sponsor ID
- RMC-0275-21
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 4 Oct 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.
To assess the association between neonatal SARS-CoV-2 antibody level at delivery and infant COVID-19 infection under age 6 months, and to identify predictive factors for neonatal antibody level at delivery.
Detailed description
This prospective observational study was conducted at the Rabin Medical Center, Israel. Mothers were enrolled from September 2021 to mid-February 2022, prior to transfer to the delivery room, and followed at the Maternity and Infant Ward. The study was approved by the institutional ethics committee (RMC- 0275-21). Written informed consent was obtained from the participating mothers. Inclusion criteria included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection. Exclusion criteria included (a) preterm birth at <34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unvaccinated, Prior natural COVID-19 infection | – | Other: no intervantionUnvaccinated, Prior natural COVID-19 infection |
| Vaccinated, No prior natural COVID-19 infection | – | Other: no intervantionVaccinated, No prior natural COVID-19 infection |
| Vaccinated, Prior natural COVID-19 infection | – | Other: no intervantionVaccinated, Prior natural COVID-19 infection |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers prior to transfer to the delivery room and followed at the Maternity and Infant Ward
Key inclusion criteria (1 listed)
- included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection
Key exclusion criteria (1 listed)
- preterm birth at <34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.
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 |
|---|---|---|
| no intervantionno intervention | Other | Unvaccinated, Prior natural COVID-19 infection, Vaccinated, No prior natural COVID-19 infection, Vaccinated, Prior natural COVID-19 infection |
Primary outcome
neonatal anti-spike antibody levels
Time frame: 6 months
Primary outcomes were neonatal anti-spike antibody levels at delivery and infant microbiologically-confirmed COVID-19 infection at age <6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No. According to ethics committee approval.
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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.
Liat Ashkenazi-Hoffnung principal investigator
Schneider children medical center
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 COVID-19, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 4 Oct 2022. 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 Israel. 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?
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?
neonatal anti-spike antibody levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2022.