RECRUITING

Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence

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 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is not known how long after someone gets sick with COVID-19 and recovers that they can still infect other people. It is also not known how quickly people make antibodies against the virus, which help clear infection from the body. The investigators will enroll 300 people who had COVID-19 based on lab testing or confirmed exposure to participate. An additional 25 participants who have never tested positive for COVID and have not had the vaccine will be enrolled as negative controls. Participants will complete a survey at enrollment. The investigators will also collect blood, nose swab, saliva, stool, semen, and breast milk to test for the virus. The investigators will ask participants to complete a survey and give specimens up to 12 times over 24 months. This information will be used to study how long the virus can live in different parts of the body, antibody development, and post-infectious complications. The investigators hope that this information will allow medical and public health providers to make recommendations to better care for patients in the convalescent phase of COVID-19 infection.

Official Title

Characterizing SARS-CoV-2 Persistence in Host Reservoirs, Post-viral Sequelae, and Associations With Host and Viral Determinants in a Cohort of Convalescent COVID-19 Cases

Quick Facts

Study Start:2020-03-26
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04448145

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:7 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Laboratory confirmed SARS-CoV-2 using currently available laboratory testing techniques (e.g.,RT-PCR, Immunoglobulin M (IgM) /IgG) or clinical history compatible with a COVID-19 like illness(fever, cough, shortness of breath).
  2. * Negative participants with no known prior COVID-19 diagnosis or COVID vaccine
  3. * At least 7 years of age
  4. * Participants are eligible to provide semen and breast milk samples if they are 18 years of age or older
  1. * Age \<7
  2. * Intercurrent conditions that in the opinion of the investigator would confound the findings of the study.

Contacts and Locations

Study Contact

Michael Yin, MD, MS
CONTACT
212-305-7185
mty4@cumc.columbia.edu
Lawrence Purpura, MD, MPH
CONTACT
212-305-2220
lp2745@cumc.columbia.edu

Principal Investigator

Michael Yin, MD, MS
PRINCIPAL_INVESTIGATOR
Associate Professor of Medicine

Study Locations (Sites)

Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Michael Yin, MD, MS, PRINCIPAL_INVESTIGATOR, Associate Professor of Medicine

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 Date2020-03-26
Study Completion Date2024-12

Study Record Updates

Study Start Date2020-03-26
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Novel Coronavirus

Additional Relevant MeSH Terms

  • COVID-19
  • Corona Virus Infection
  • SARS-CoV 2