Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) (PRIORITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323839
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date March 24, 2020
First Posted Date March 27, 2020
Last Update Posted Date April 24, 2020
Actual Study Start Date March 20, 2020
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 24, 2020)
  • Clinical presentation [ Time Frame: Baseline to 12 months ]
    presenting symptoms and testing
  • Disease prognosis outcomes [ Time Frame: Baseline to 12 months ]
    Clinical outcomes with resolution of illness
  • Pregnancy outcomes [ Time Frame: Baseline to 12 months ]
    Pregnancy outcomes among women infected with COVID-19
  • Obstetric outcomes [ Time Frame: Baseline to 12 months ]
    Obstetric outcomes among women infected with COVID-19
  • Neonatal outcomes [ Time Frame: Baseline to 12 months ]
    Neonatal outcomes among infants born to women with COVID-19
  • Modes of transmission of COVID-19 [ Time Frame: Baseline to 12 months ]
    Transmission of COVID-19 from mother to infant
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)
Official Title PRIORITY (Pregnancy Coronavirus Outcomes Registry)
Brief Summary PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) is a prospective cohort study of pregnant and recently pregnant women who are: either patients under investigation for COVID-19 or a confirmed case of COVID-19. Data from PRIORITY will be used to evaluate the impact of COVID-19 on the clinical course and pregnancy outcomes of pregnant women and women within 6 weeks of pregnancy.
Detailed Description

The investigators will recruit women age 13 or older under investigation for COVID-19 or with confirmed COVID-19 at any clinical state across the United States. Eligible participants will be identified through voluntary physician referrals.

When an eligible patient is referred to the PRIORITY Coordinating Center at UCSF, a UCSF study coordinator will follow-up by phone with the patient and consent verbally. The participant will be asked to complete an approval to release medical information. The investigators will use patient questionnaires to assess symptoms, maternal clinical course, pregnancy outcomes, and neonatal outcomes from initial investigation of COVID-19 to 12 months. The investigators will also obtain all medical records for the participant to data abstract key clinical and pregnancy outcomes.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women or women who have been pregnant in the last 6 weeks and are under investigation for COVID-19 or who have tested positive for COVID-19.
Condition
  • Pregnancy
  • Coronavirus
  • COVID-19
Intervention
  • Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19
    This is an observational study with no intervention
  • Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19
    This is an observational study with no intervention
Study Groups/Cohorts
  • Pregnant Women
    Women who are currently pregnant and are suspected or diagnosed COVID-19 positive.
    Intervention: Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19
  • Post-partum women
    Women who have been pregnant in the past 6 weeks and are suspected or diagnosed COVID-19 positive.
    Intervention: Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 22, 2020)
2000
Original Estimated Enrollment
 (submitted: March 24, 2020)
1000
Estimated Study Completion Date March 31, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Pregnant women or women who have been pregnant within the last 6 weeks
  2. Able to give informed consent
  3. Diagnosed with COVID-19; or being evaluated for COVID-19 ("patient under investigation") since January 1, 2020

Exclusion Criteria:

1. <13 years of age.

Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Persons assigned gender female at birth.
Ages 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ruth Gebrezghi (415) 754-3749 PRIORITYCOVID19@ucsf.edu
Contact: Vanessa Monzon (415) 754-3749 PRIORITYCOVID19@ucsf.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04323839
Other Study ID Numbers 20-30410
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators University of California, Los Angeles
Investigators
Principal Investigator: Vanessa Jacoby, MD, MAS University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date April 2020