N3C Public Health Answers to Speed Tractable Results (PHASTR)
NCATS launched N3C PHASTR to address high-impact questions that were not being investigated by the research community. The effort was also funded by the NIH National Institute of General Medical Sciences.
The following questions were proposed for applicants:
Does metformin show a reduction of severe outcomes of COVID-19 or of Long COVID in the N3C Data Enclave
A recent clinical trial (COVID-OUT) demonstrated that metformin lowered the odds of emergency department visits, hospitalizations, or death by over 40% and also decreased the incidence of long COVID as diagnosed by a medical provider. The fundamental question being asked is: Does metformin reduce the incidence of severe outcomes of COVID-19 and/or prevent Long COVID?
https://www.nejm.org/doi/full/10.1056/NEJMoa2201662
https://www.medrxiv.org/content/10.1101/2022.12.21.22283753v1
Application Deadline: Aug 31, 2023
Contract Amount: 50000
Does molnupiravir show a reduction of severe outcomes of COVID-19 in the N3C Data Enclave
Molnupiravir has demonstrated variable effects on the risk of hospitalization or mortality among outpatients with COVID-19. Prior results from the randomized, placebo-controlled MOVe-OUT trial demonstrated a statistically significant reduction in the risk of all-cause hospitalization or death in unvaccinated patients at increased risk, while a more recent randomized open-label study (PANORAMIC) in a high-risk vaccinated population disclosed no impact on all-cause hospitalization or death (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02597-1/fulltext). The question to be addressed is: Does molnupiravir reduce the risk of hospitalization or death within one month of COVID-19 in at-risk patients with COVID-19 in the N3C population, controlling for confounding variables such as vaccination, risk factors for severe outcomes, concomitant therapy, and variant epoch.
Application Deadline: Aug 31, 2023
Contract Amount: 50000
Is Long COVID associated with an increased risk of mortality?
Long COVID (post-acute sequelae of COVID-19) has been associated with a variety of clinical manifestations that may produce lasting morbidity, but the impact of Long COVID on mortality risk remains unclear. A recent descriptive study of death certificate data in the US National Vital Statistics System (https://stacks.cdc.gov/view/cdc/121968) has disclosed cases in which long COVID terms appeared in death certificates, indicating Long COVID as an underlying or contributing cause of death. The fundamental question being asked is: Is Long COVID associated with an increased risk of mortality relative to patients who experience acute COVID-19 not followed by Long COVID, and a population of uninfected individuals.
Application Deadline: Feb 15, 2023
Contract Amount: 50000
Use of the N3C enclave and machine learning to create generalizable algorithms that predict patient outcomes at (a) diagnosis, and (b) time of hospitalization
Over the last three years, many studies have sought to identify risk factors for more severe SARS-CoV-2 infection and adverse outcomes of COVID-19. Since the onset of the pandemic, progressive insights have been gained into demographic and clinical features, co-morbidities, various biomarkers, therapeutic strategies, and social factors that affect acute disease outcomes among outpatients and inpatients. The fundamental question being asked is: Based on knowledge concerning prognostic factors that has accrued since 2019, can the N3C enclave be leveraged to identify generalizable algorithms that predict hospitalization, disease severity, and mortality associated with SARS-CoV-2 infection?
Application Deadline: Feb 15, 2023
Contract Amount: 50000
Does the use of UDCA (ursodeoxycholic acid) at baseline reduce the incidence and/or severity of COVID-19?
Recently published preclinical data (link below) suggest ursodeoxycholic acid (UDCA) may inhibit SARS-CoV-2 infection through downregulation of expression of the ACE2 receptor. Although this agent is used in clinical practice for other indications, it has not been evaluated in clinical trials to assess its impact on SARS-CoV-2 infection. The fundamental question being asked is: Does UDCA use at baseline reduce the incidence and/or severity of COVID-19?
https://www.nature.com/articles/s41586-022-05594-0
Application Deadline: Feb 15, 2023
Contract Amount: 50000
SARS-CoV-2 Reinfection Severity
Does reinfection with SARS-CoV-2 compared to first infection produce clinical illness that is more severe, the same as, or less severe compared to initial SARS-CoV-2 infection?
https://www.researchsquare.com/article/rs-1749502/v1
Application Deadline: Nov 25, 2022
Contract Amount: 50000
Neurologic sequelae COVID
What is the spectrum of neurologic sequelae at 12 months following infection in survivors of acute COVID, compared to individuals who have not had COVID?
https://www.nature.com/articles/s41591-022-02001-z
Application Deadline: Nov 25, 2022
Contract Amount: 50000
About PHASTR
Background
The N3C PHASTR initiative was designed to quickly address high-impact questions that can be answered with N3C data. These questions were identified by NCATS and NIH leadership. Successful proposals were awarded a short-term contract.
Goals
Provided fast, actionable analysis of high-impact, public health research questions. Engaged the community capable of working with N3C “big data” to answer public health-related research questions of interest. Successful offerors were offered a subcontract by the NCATS contractor to complete the work
Contact Information
For questions about the initiative, please contact publichealth@nih.gov. For other inquiries about N3C, email
FAQs
Public health questions came from a variety of sources, including investigators, NIH staff, policy, and regulatory agencies.
This varied with each question and started after the contract had been finalized with the institution. The time can be found in the Application Information Section Clock.
Each question had a detailed description of what was expected. NCATS' goal was to make the results of the information broadly available, and NCATS posted them on the N3C public health dashboard. This included a short description of the results as well as any tabular output needed for visualization of the information.
All subcontractor proposals were reviewed by a federal prime contractor, Axle Informatics; an information contractor; and their scientific specialist.
For inquiries about the initiative, please contact publichealth@nih.gov. For other inquiries about N3C, email n3c.info@govcollab.io.
The contract mechanism was chosen because expectations and deliverables are clearly defined.
Yes, all analyses were within the N3C Data Enclave.
To Cite the N3C: "The analyses described in this [publication/report/presentation] were conducted with data or tools accessed through the NCATS N3C Data Enclave https://covid.clinicalcohort.org and N3C Attribution & Publication Policy v 1.2-2020-08-25b supported by NCATS Contract No. 75N95023D00001 and [insert additional funding agencies or sources and reference numbers as declared by the contributors in their form response above]. This research was possible because of the patients whose information is included within the data and the organizations (https://ncats.nih.gov/n3c/resources/data-contribution/data-transfer-agreement-signatories) and scientists who have contributed to the on-going development of this community resource [https://doi.org/10.1093/jamia/ocaa196]."
For publication submission information, please see the Publication Review Page