SARS-COV-2 InfectionNCT05124574
Transplacental Transmission of COVID-19
An observational study of SARS-COV-2 Infection, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
SARS-CoV-2, the agent responsible for pandemic COVID-19 infection, is transmitted mainly by respiratory droplets. Regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- SARS-COV-2 Infection
- What is being tested?
- Samples concern SARS-COV-2 + pregnant women at the time of childbirth and Samples concern newborns of SARS-COV-2 + mothers at birth
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 2 Mar 2022
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant woman with proven SARS-COV-2 infection during full-term delivery
Who may be able to join
- Social security affiliation
- Signed informed consent
- Pregnant woman with proven SARS-COV-2 infection during full-term delivery
Who cannot join
- Patient vaccinated within 15 days prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Transplacental Transmission of SARS-COV-2 (COVID-19) in a Cohort of 10 Mother/Child Dyads
SARS-CoV-2, the agent responsible for pandemic COVID-19 infection, is transmitted mainly by respiratory droplets. Regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of placental contamination, trans-cervical or by environmental exposure. .
The case described by J. Vivanti of a newborn with neonatal neurological involvement and whose mother had been infected during the last trimester of pregnancy reports possible transplacental transmission in a context of positive and elevated viremia in the mother and positive viremia in the newborn.
Read the detailed description
In 2021, it becomes essential to clarify if and how SARS-COV-2 reaches the fetus, in order to prevent neonatal infection, optimize pregnancy management and better understand the pathogenesis of COVID-19.
SARS-COV-2, ACE2 and TMPRSS2 co-receptors are highly expressed in placental tissues and may be actively involved in transplacental transmission of the virus. From a case of materno-fetal transmission described by our team (publication in progress), we observed placental expression of the Spike SARS-COV-2 protein, but also of the ACE2 receptors, TMPRSS2 and cathepsin L. Cytotrophoblast and syncytiotrophoblast cell stains were positive within the placental villi. Maternal leukocytes were also labeled for these proteins.
- Conditions
- SARS-COV-2 Infection
- Being tested
- Samples concern SARS-COV-2 + pregnant women at the time of childbirth, Samples concern newborns of SARS-COV-2 + mothers at birth
- Keywords
- immune response, SARS-COV-2, ACE2 receptors, MPRSS2, cathepsin L
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples concern SARS-COV-2 + pregnant women at the time of childbirthOther
- nasopharyngeal PCR in the mother (performed systematically in this epidemic context),
- Blood samples: 1 EthyleneDiamineTetraacetic Acid (EDTA) tube (immunohistochemistry), 1 yellow tube (COVID + RT-qPCR serology).
- Sampling of amniotic fluid in case of cesarean section
- Sampling of the placenta for histological and virological study.
Samples concern newborns of SARS-COV-2 + mothers at birthOther
- In the birth room:
- Collection of gastric fluid (PCR SARS-COV-2),
- Cord blood: 1 EDTA tube (immunohistochemistry), 1 yellow tube (SARS-COV-2 + RT-qPCR serology).
- In the newborn at D3 of life:
- 1 yellow tube (SARS-COV-2 + RT-qPCR serology) at the same time as the DNN.
- In symptomatic newborns:
- 1 yellow tube (SARS-COV-2 + RT-qPCR serology).
- nasopharyngeal PCR,
| Study group | Role | What they receive |
|---|---|---|
| mothers infected with SARS-COV-2 at the time of delivery. | Maternal-fetal transmission of SARS-COV-2 is likely and may require co-expression of the virus receptor (ACE2) and at least one activator of virus internalization (TMPRSS2 and/or cathepsin) in a cell to make it susceptible to SARS-COV-2 infection.
To confirm these hypotheses, it is necessary to explore these mechanisms of fetal transmission in a larger number of mothers infected with SARS -CoV-2 at the time of delivery.
Informed information will be given in the delivery room, initially orally by the midwives, to any mother presenting with an SARS-COV-2 infection (symptomatic or not) (whatever the variant involved). An information leaflet will also be given to the patient and consent will be systematically obtained. Receives: Other: Samples concern SARS-COV-2 + pregnant women at the time of childbirth; Other: Samples concern newborns of SARS-COV-2 + mothers at birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spike SARS-COV-2 protein in placental tissues
number of cells expressing the Spike SARS-COV-2 protein
Measured: Baseline : childbirth
Secondary outcomes (3)
ACE2 receptors in placental tissues
number of cells expressing the ACE2 receptors
Measured: Baseline : childbirth
TMPRSS2 in placental tissues
number of cells expressing the TMPRSS2
Measured: Baseline : childbirth
cathepsin L in placental tissues
number of cells expressing the cathepsin L
Measured: Baseline : childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Dec 2021
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Why it stopped: No cases of COVID recorded in maternity wards since April 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-COV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugues PATURAL, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124574
- Sponsor's protocol ID
- IRBN1362021
- Status last verified
- Jun 2023
- First submitted
- 16 Nov 2021
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Transplacental Transmission of SARS-COV-2 (COVID-19) in a Cohort of 10 Mother/Child Dyads
- ClinicalTrials.gov ID
- NCT05124574
- Acronym / sponsor ID
- IRBN1362021
- Conditions
- SARS-COV-2 Infection
- Keywords
- immune response, SARS-COV-2, ACE2 receptors, MPRSS2, cathepsin L
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No cases of COVID recorded in maternity wards since April 2022
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 18 Nov 2021 (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.
SARS-CoV-2, the agent responsible for pandemic COVID-19 infection, is transmitted mainly by respiratory droplets. Regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of placental contamination, trans-cervical or by environmental exposure. .
The case described by J. Vivanti of a newborn with neonatal neurological involvement and whose mother had been infected during the last trimester of pregnancy reports possible transplacental transmission in a context of positive and elevated viremia in the mother and positive viremia in the newborn.
Detailed description
In 2021, it becomes essential to clarify if and how SARS-COV-2 reaches the fetus, in order to prevent neonatal infection, optimize pregnancy management and better understand the pathogenesis of COVID-19.
SARS-COV-2, ACE2 and TMPRSS2 co-receptors are highly expressed in placental tissues and may be actively involved in transplacental transmission of the virus. From a case of materno-fetal transmission described by our team (publication in progress), we observed placental expression of the Spike SARS-COV-2 protein, but also of the ACE2 receptors, TMPRSS2 and cathepsin L. Cytotrophoblast and syncytiotrophoblast cell stains were positive within the placental villi. Maternal leukocytes were also labeled for these proteins.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mothers infected with SARS-COV-2 at the time of delivery. | – | Other: Samples concern SARS-COV-2 + pregnant women at the time of childbirth, Other: Samples concern newborns of SARS-COV-2 + mothers at birthMaternal-fetal transmission of SARS-COV-2 is likely and may require co-expression of the virus receptor (ACE2) and at least one activator of virus internalization (TMPRSS2 and/or cathepsin) in a cell to make it susceptible to SARS-COV-2 infection. To confirm these hypotheses, it is necessary to explore these mechanisms of fetal transmission in a larger number of mothers infected with SARS -CoV-2 at the time of delivery. Informed information will be given in the delivery room, initially orally by the midwives, to any mother presenting with an SARS-COV-2 infection (symptomatic or not) (whatever the variant involved). An information leaflet will also be given to the patient and consent will be systematically obtained. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant woman with proven SARS-COV-2 infection during full-term delivery
Key inclusion criteria (3 listed)
- Social security affiliation
- Signed informed consent
- Pregnant woman with proven SARS-COV-2 infection during full-term delivery
Key exclusion criteria (1 listed)
- Patient vaccinated within 15 days prior to inclusion
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 |
|---|---|---|
| Samples concern SARS-COV-2 + pregnant women at the time of childbirth* nasopharyngeal PCR in the mother (performed systematically in this epidemic context), * Blood samples: 1 EthyleneDiamineTetraacetic Acid (EDTA) tube (immunohistochemistry), 1 yellow tube (COVID + RT-qPCR serology). * Sampling of amniotic fluid in case of cesarean section * Sampling of the placenta for histological and virological study. | Other | mothers infected with SARS-COV-2 at the time of delivery. |
| Samples concern newborns of SARS-COV-2 + mothers at birth* In the birth room: * Collection of gastric fluid (PCR SARS-COV-2), * Cord blood: 1 EDTA tube (immunohistochemistry), 1 yellow tube (SARS-COV-2 + RT-qPCR serology). * In the newborn at D3 of life: - 1 yellow tube (SARS-COV-2 + RT-qPCR serology) at the same time as the DNN. * In symptomatic newborns: * 1 yellow tube (SARS-COV-2 + RT-qPCR serology). * nasopharyngeal PCR, | Other | mothers infected with SARS-COV-2 at the time of delivery. |
Primary outcome
Spike SARS-COV-2 protein in placental tissues
Time frame: Baseline : childbirth
number of cells expressing the Spike SARS-COV-2 protein
3 secondary outcomes
ACE2 receptors in placental tissues
Time frame: Baseline : childbirth
TMPRSS2 in placental tissues
Time frame: Baseline : childbirth
cathepsin L in placental tissues
Time frame: Baseline : childbirth
Results and safety
The study was stopped early (reason given: No cases of COVID recorded in maternity wards since April 2022). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugues PATURAL, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 SARS-COV-2 Infection, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 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: stopped early, as of the sponsor's last update on 23 Jun 2023. 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 France. 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?
The study was stopped early (reason given: No cases of COVID recorded in maternity wards since April 2022). 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?
Spike SARS-COV-2 protein in placental tissues (time frame: Baseline : childbirth). 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 23 Jun 2023.