Covid19NCT04362956
Clinical and Immunologic Impact of Perinatal SARS-CoV-2 (COVID-19) Infection
An observational study of Covid19 and Pregnancy Related, run by Fundacion Infant at 1 site in Argentina.
Trial summary
This is a multi-center prospective study that aims to investigate the clinical and immunologic impact of SARS-CoV-2 infection in pregnant women and neonates. The goal is to recruit 200 SARS-CoV-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Covid19, Pregnancy Related, Neonatal Infection
- How many people
- 114 participants
- Where
- 1 siteArgentina
- Study dates
- 10 Jul 2020to 1 Oct 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Elegible patients will be all pregnant women of 9 large maternity hospitals in Argentina.
Who may be able to join
- Pregnant women hospitalized presenting with:
- Fever with one or more respiratory symptoms (cough, odinophagia, respiratory difficulty)
- Diagnoses of pneumonia with no other explainable cause.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina
This is a multi-center prospective study that aims to investigate the clinical and immunologic impact of SARS-CoV-2 infection in pregnant women and neonates. The goal is to recruit 200 SARS-CoV-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. Clinical data will be collected from women and neonates. Upper airways samples will be obtained from both for bio-markers investigation. Finally, maternal and umbilical cord serum and human milk will be obtained for antibody assessment.
Read the detailed description
COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, has led to an unprecedented global pandemic affecting persons of all ages. Pregnant women are in a physiologic immunosuppressed situation and have a greater risk and severity of respiratory infection. However, considerable uncertainty exists regarding the potential for vertical transmission (prenatal/congenital or perinatal) of SARS-CoV-2 from infected pregnant women to their newborns and its potential clinical consequences.
This study attempts to provide evidence-based guidelines for managing antenatal, intrapartum, and neonatal care around COVID-19 require an understanding of whether the virus can be transmitted transplacentally; a determination of which maternal body fluids may be infectious; trasnplacental and human milk antibody transfer and data of adequate statistical power that describe which maternal, intrapartum, and neonatal factors influence perinatal transmission.
- Conditions
- Covid19, Pregnancy Related, Neonatal Infection
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical transmission
Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate
Measured: 96 hours from birth
Neonatal protection due to maternal antibodies
Presence of IgG in umbilical cord
Measured: 24 weeks of gestation to birth
Secondary outcomes (2)
Increase risk of neonatal morbidity
Respiratory distress, hypothermia, poor feeding and others
Measured: up to 30 days of life
Increase risk of obstetric complications
Measured: Up to 14 days of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start10 Jul 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Infant
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362956
- Sponsor's protocol ID
- Perinatal COVID-19
- Status last verified
- Feb 2021
- First submitted
- 21 Apr 2020
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larcade R, DeShea L, Lang GA, Caballero MT, Ferretti A, Beasley WH, Tipple TE, Vain N, Prudent L, Lang ML, Polack FP, Ofman G. Maternal-Fetal Immunologic Response to SARS-CoV-2 Infection in a Symptomatic Vulnerable Population: A Prospective Cohort. J Infect Dis. 2022 Mar 2;225(5):800-809. doi: 10.1093/infdis/jiab591.
PubMed 34865064
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina
- ClinicalTrials.gov ID
- NCT04362956
- Acronym / sponsor ID
- Perinatal COVID-19
- Conditions
- Covid19, Pregnancy Related, Neonatal Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Fundacion InfantUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 27 Apr 2020 (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.
This is a multi-center prospective study that aims to investigate the clinical and immunologic impact of SARS-CoV-2 infection in pregnant women and neonates. The goal is to recruit 200 SARS-CoV-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. Clinical data will be collected from women and neonates. Upper airways samples will be obtained from both for bio-markers investigation. Finally, maternal and umbilical cord serum and human milk will be obtained for antibody assessment.
Detailed description
COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, has led to an unprecedented global pandemic affecting persons of all ages. Pregnant women are in a physiologic immunosuppressed situation and have a greater risk and severity of respiratory infection. However, considerable uncertainty exists regarding the potential for vertical transmission (prenatal/congenital or perinatal) of SARS-CoV-2 from infected pregnant women to their newborns and its potential clinical consequences.
This study attempts to provide evidence-based guidelines for managing antenatal, intrapartum, and neonatal care around COVID-19 require an understanding of whether the virus can be transmitted transplacentally; a determination of which maternal body fluids may be infectious; trasnplacental and human milk antibody transfer and data of adequate statistical power that describe which maternal, intrapartum, and neonatal factors influence perinatal transmission.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Elegible patients will be all pregnant women of 9 large maternity hospitals in Argentina.
Key inclusion criteria (3 listed)
- Pregnant women hospitalized presenting with:
Key exclusion criteria (1 listed)
- None
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
Vertical transmission
Time frame: 96 hours from birth
Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate
Neonatal protection due to maternal antibodies
Time frame: 24 weeks of gestation to birth
Presence of IgG in umbilical cord
2 secondary outcomes
Increase risk of neonatal morbidity
Time frame: up to 30 days of life
Increase risk of obstetric complications
Time frame: Up to 14 days of hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Derived from this study: PubMed 34865064Larcade R, DeShea L, Lang GA, Caballero MT, Ferretti A, Beasley WH, Tipple TE, Vain N, Prudent L, Lang ML, Polack FP, Ofman G. Maternal-Fetal Immunologic Response to SARS-CoV-2 Infection in a Symptomatic Vulnerable Population: A Prospective Cohort. J Infect Dis. 2022 Mar 2;225(5):800-809. doi: 10.1093/infdis/jiab591.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 and Pregnancy Related, run by Fundacion Infant at 1 site in Argentina.
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: finished, as of the sponsor's last update on 12 Mar 2025. 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 Argentina. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vertical transmission (time frame: 96 hours from birth). The study lists 2 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 NCT04362956, which also lists 1 linked publication.
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 12 Mar 2025.