COVID-19 Research and NICHD

NICHD aims to improve understanding of how SARS-CoV-2 infection and disease affect women who are pregnant or have just given birth, as well as their newborns. These efforts seek to determine whether pregnancy influences the course of COVID-19, to establish the risk of transmitting SARS-CoV-2 to the fetus during pregnancy or to the infant during breastfeeding, to delineate how COVID-19 affects the long-term health of mothers and their children, and to ensure that any COVID-19–related treatments are adequately formulated and tested for their specific needs.

Some newly initiated NICHD research projects include the following:

• In the Gestational Research Assessments for COVID-19 (GRAVID) study, NICHD-funded researchers will analyze medical records of up to 24,500 women who have given birth recently at a clinical center within NICHD’s Maternal-Fetal Medicine Units (MFMU) Network. This group of 12 U.S. clinical centers covers more than 160,000 deliveries per year and has appropriate racial, ethnic, and geographic diversity to allow researchers to generalize study findings to the U.S. population. The study will evaluate whether pregnant and immediately postpartum women experience increased morbidity and mortality during the COVID-19 pandemic than before it; whether pregnant women with SARS-CoV-2 experience higher morbidity and mortality than pregnant women who don’t have SARS-CoV-2; and describe maternal and neonatal outcomes data for pregnant and immediately postpartum women with confirmed SARS-CoV-2 infection. They will also contribute the outcomes data to the COVID-19 Pregnancy Registry Study, which is also conducted through the MFMU Network.
• A similar study will be conducted to estimate the prevalence of SARS-CoV-2 infection during pregnancy at eight sites within the NICHD-funded Global Network for Women’s and Children’s Health Research. Using antibody testing at delivery, the study seeks to compare the maternal, fetal, and neonatal outcomes of women infected with SARS-CoV-2 to those of non-infected women. The study will enroll approximately 2,000 pregnant women for each site in Kenya, Zambia, Guatemala, India (Belagavi and Nagpur), Democratic Republic of the Congo, Pakistan, and Bangladesh.
• NICHD’s Perinatology Research Branch is studying the effects of COVID-19 on pregnant women who give birth at Detroit Medical Center in Michigan.
• NICHD is also supporting researchers at the Johns Hopkins Center for Humanitarian Healthin compiling a repository of recent peer-reviewed journal articles on COVID-19, breastfeeding, infant feeding, and breast milk .

Diana W. Bianchi, M.D., the director of NICHD, describes some of the institute’s activities in a recent HHS blog post, The Impact of the Pandemic on Pregnancy: A Research Response .

There is a great deal to learn about how SARS-CoV-2 affects children. Children can become infected with the virus that causes COVID-19 and can get sick with COVID-19. Most have mild or no symptoms. Children with underlying medical conditions and infants less than 1 year old may be at increased risk for severe illness from COVID-19.

Physicians around the world have reported an increase in cases and deaths linked to Multisystem Inflammatory Syndrome in Children (MIS-C) that seems to be related to previous exposure to the SARS-CoV-2 virus. MIS-C is a spectrum of inflammatory processes with features that overlap with toxic shock syndrome and are similar to the heart condition known as Kawasaki disease. MIS-C can present with symptoms seemingly unrelated to COVID-19, such as severe abdominal pain. MIS-C usually affects school-age children, specifically those who were previously healthy and who may have initially had only mild COVID-19 symptoms or no symptoms at all.

NICHD’s activities related to COVID-19 in children and MIS-C include the following:

• As part of NIH’s Collaboration to Assess Risk and Identify Long-term Outcomes for Children with COVID (CARING for Children with COVID) program, the NICHD-funded Pediatric Trials Network (PTN) is conducting the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02) study on the dosing and safety of drugs currently being used to treat children with COVID-19. PTN researchers are analyzing blood samples collected from routine medical procedures to understand how drugs move through the bodies of children, from newborns to adolescents younger than 21 years of age. They also will collect information on potential side effects and patient outcomes, such as the type of respiratory support needed and length of hospital stay. The study is not designed to evaluate which drug is the best treatment for COVID-19. The CARING for Children with COVID project aims to better understand why symptoms vary among children with COVID-19 disease, and how to identify children at risk for severe illness from SARS-CoV-2 infection, including MIS-C. NIH effort seeks to understand MIS-C, range of SARS-CoV-2 effects on children explains more about the CARING for Children with COVID program.
• An NICHD-led project—Predicting Viral-Associated Inflammatory Disease Severity in Children with Laboratory Diagnostics and Artificial Intelligence (PreVAIL kIds)—aims to encourage development of cutting-edge approaches for understanding the underlying factors that influence the spectrum of conditions that may occur in children infected with the SARS-CoV-2 virus. Part of the trans-NIH RADx initiative, PreVAIL kIds aims to understand the range of symptoms of COVID-19 and the factors leading to MIS-C. Studies funded through PreVAIL kIds will evaluate genes and other biomarkers in COVID-19 pediatric cases, as well as examine how the virus interacts with its host and how the immune system responds.

Learn more about SARS-CoV-2 and COVID-19 in children by reading the NIH Director’s Blog post, What We Know About COVID-19’s Effects on Child and Maternal Health, which features highlights from an interview with NICHD Director Diana W. Bianchi, M.D., and NIH Director Francis S. Collins, M.D., Ph.D.

Safe Return to School For All summarizes current evidence and best practices to help administrators, educators, and families and students—including students with disabilities—return to school safely in the context of COVID-19. The information provided is based on collaborative research from the NICHD-funded Washington University Intellectual and Developmental Disabilities Research Center, the University of Missouri-Kansas City Institute of Human Development, and the Kennedy Krieger Institute (Maryland), in collaboration with the Special School District of St. Louis County, Missouri.

NICHD is participating in NIH’s RADx-UP program to understand the factors associated with disparities in COVID-19 morbidity and mortality and to reduce disparities for underserved and vulnerable populations disproportionately affected by, have the highest infection rates of, and/or are most at risk for complications or poor outcomes from COVID-19.

The RADx-UP program, part of the overall RADx initiative, will work closely with and within communities to develop and rapidly implement interventions and increase access and use of U.S. Food and Drug Administration-approved tests for COVID-19 and antibody testing for present and past infections among underserved populations. The objective of RADx-UP is to collect high-quality testing data to understand the prevalence, treatment, and outcome disparities  of COVID-19 and to identify the effects of public health measures on underserved populations. To learn more about RADx-UP, read the NICHD Director’s Corner blog post, NIH One Step Closer to Speeding Delivery of COVID-19 Testing Technologies to Those Who Need It Most Through RADx-UP.

NICHD is also studying how people with intellectual and developmental disabilities are disproportionately affected by COVID-19. Read more about what researchers in the NICHD-funded Intellectual & Developmental Disabilities Research Centers (IDDRC) Network are learning about COVID-19 in this community.

Through NICHD’s intramural program, NICHD researchers who lead their own laboratories and research programs at NIH are also leveraging their areas of expertise to address the pandemic.

Some of this research focuses on understanding the biology of SARS-CoV-2, its effects on the placenta and on lung tissue, and what mechanisms lead to severe symptoms and death among older people and those with underlying health conditions. Other NICHD researchers are studying possible targets for prevention and treatment measures.

NICHD researchers are also working to develop and improve technologies and resources to help advance COVID-19 research. These activities include creating materials that protect surfaces from viral particles and improving methods of testing possible vaccines and treatments. Some recent papers on COVID-19 from NICHD intramural researchers include the following:

• Prevalence of Diabetes and Hypertension and Their Associated Risks for Poor Outcomes in Covid-19 Patients (PMID: 32885126)
• Endocrine Conditions and COVID-19 (PMID: 32512611)
• Hookah Smoking and COVID-19: Call for Action (PMID: 32392495)
• Does the human placenta express the canonical cell entry mediators for SARS-CoV-2? (PMID: 32662421)

The following NOTs and FOAs related to COVID-19 are relevant for NICHD:

• NOT-MH-21-225: Notice of Special Interest (NOSI): COVID-19 Related School Disruptions Impact on Mental Health, Cognitive, Social, and Emotional Development of Children
• NOT-OD-21-097: Notice of Intent to Publish a Research Opportunity Announcement for RADx-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)
• RFA-OD-20-023: Emergency Awards: RADx-rad Predicting Viral-Associated Inflammatory Disease Severity in Children with Laboratory Diagnostics and Artificial Intelligence (PreVAIL kIds) (R61/R33 Clinical Trial Optional)
• RFA-OD-20-019: Emergency Awards: RADx-rad Data Coordination Center (DCC) (U24 Clinical Trial Not Allowed)
• PAR-20-237: Community Interventions to Address the Consequences of the COVID-19 Pandemic among Health Disparity and Vulnerable Populations (R01 - Clinical Trial Optional)
• PAR-20-243: Digital Healthcare Interventions to Address the Secondary Health Effects Related to Social, Behavioral, and Economic Impact of COVID-19 (R01 - Clinical Trial Optional)
• NOT-OD-20-129: NOSI regarding the Availability of Urgent Competitive Revisions and Administrative Supplements for Research on Coronavirus Disease 2019 (COVID-19) in Individuals with Down Syndrome for the INCLUDE Project
• PA-20-135: Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional)
• NOT-MD-20-022: Notice of Special Interest (NOSI): Competitive and Administrative Supplements for Community Interventions to Reduce the Impact of COVID-19 on Health Disparity and Other Vulnerable Populations
• NOT-MD-20-023: Notice of Intent to Publish an FOA for Community Interventions to Address the Consequences of the COVID-19 Pandemic for Health Disparity and Vulnerable Populations (R01 - Clinical Trial Optional)
• NOT-MH-20-053: NOSI: Digital Healthcare Interventions to Address the Secondary Health Effects Related to Social, Behavioral, and Economic Impact of COVID-19
• NOT-MH-20-058: Notice of Intent to Publish a Funding Opportunity Announcement for Digital Healthcare Interventions to Address the Secondary Health Effects Related to Social, Behavioral, and Economic Impact of COVID-19 (R01 - Clinical Trial Optional)
• NOT-OD-20-097: NOSI Regarding the Availability of Administrative Supplements and Urgent Competitive Revisions for Research on the 2019 Novel Coronavirus and the Behavioral and Social Sciences
• NOT-OD-20-112: Notice of Intent to Publish Funding Opportunity Announcements for the RADx-UP Initiatives
• NOT-OD-20-119: NOSI: Emergency Competitive Revisions for Social, Ethical, and Behavioral Implications (SEBI) Research on COVID-19 Testing among Underserved and/or Vulnerable Populations
• NOT-OD-20-120: NOSI: Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations
• NOT-OD-20-121: NOSI: Limited Competition for Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations
• RFA-OD-20-013: Emergency Awards: RADx-UP Coordination and Data Collection Center (CDCC) (U24 Clinical Trial Optional)

• A complete list of current NOTs and FOAs for all of NIH can be found by visiting the Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding webpage
• NIH provides up-to-date information on COVID-19 research and activities.
• NIH’s Rapid Acceleration of Diagnostics (RADx) webpage includes details on the RADx Tech and RADx-UP programs.
• Overview of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative.
• The Coronavirus.gov website provides information about COVID-19 symptoms, diagnoses, and treatments.

For up-to-date NICHD COVID-19 news, funding opportunities, and research spotlights, follow NICHD on Facebook , Instagram , Twitter , or LinkedIn .