Transplacental Transmission of COVID-19

SARS-COV-2 Infection Clinical Trial

Official title:

Prospective Evaluation of Transplacental Transmission of SARS-COV-2 (COVID-19) in a Cohort of 10 Mother/Child Dyads

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05124574
• Other study ID #: IRBN1362021
• Status: Terminated
• Start date: December 1, 2021
• Est. completion date: March 2, 2022

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Social security affiliation

• Signed informed consent

• Pregnant woman with proven SARS-COV-2 infection during full-term delivery

Exclusion Criteria:

• Patient vaccinated within 15 days prior to inclusion

Related Conditions & MeSH terms

• COVID-19
• SARS-COV-2 Infection

Intervention

Other:
• 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.
• 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,

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spike SARS-COV-2 protein in placental tissues	number of cells expressing the Spike SARS-COV-2 protein	Baseline : childbirth
Secondary	ACE2 receptors in placental tissues	number of cells expressing the ACE2 receptors	Baseline : childbirth
Secondary	TMPRSS2 in placental tissues	number of cells expressing the TMPRSS2	Baseline : childbirth
Secondary	cathepsin L in placental tissues	number of cells expressing the cathepsin L	Baseline : childbirth