RECRUITING

COVID-19 International Drug Pregnancy Registry

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Covid19

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is to evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from the first day of the last menstrual period (LMP) to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP.

Official Title

COVID-19 International Drug Pregnancy Registry (COVID-PR)

Quick Facts

Study Start:2021-12-01
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05013632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant or recently pregnant (up to 30 days after the end of pregnancy) at time of enrollment
  2. * Age ≥18 years at time of enrollment
  3. * With mild to severe COVID-19 during pregnancy
  4. * Either
  5. * Treated for COVID-19 with at least one of the medications included in Table 1 during pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP or
  6. * Hospitalized and did not receive any pharmacological treatment specifically indicated for mild, moderate, or severe COVID-19 during pregnancy
  7. * Resident of a country where a Central Institutional Review Board (IRB) or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study
  8. * Signed the informed consent form and submitted the baseline module "COVID-19 Medications During This Pregnancy"
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Diego Wyszynski, MD, MHS, PhD
CONTACT
18006163791
covid-pr@pregistry.com

Principal Investigator

Diego Wyszynski, MD, MHS, PhD
PRINCIPAL_INVESTIGATOR
Pregistry

Study Locations (Sites)

Pregistry
Los Angeles, California, 90045
United States

Collaborators and Investigators

Sponsor: Pregistry

  • Diego Wyszynski, MD, MHS, PhD, PRINCIPAL_INVESTIGATOR, Pregistry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-01
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2021-12-01
Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Covid19