Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection. COV… (NCT04259892) | Clinical Trial Compass
CompletedNot Applicable
Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection. COVID-19.
France, French Guiana324 participantsStarted 2020-02-04
Plain-language summary
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.
Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.
Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.
Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. High/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case;
. Within the 14 days following the last contact with a laboratory-confirmed SARS-CoV-2 case;
. Obtaining informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tracked how long people shed the SARS-CoV-2 virus after being exposed to a confirmed COVID-19 case — based on what this study found, how does that change how long I or a close contact of mine should isolate after a high-risk exposure?
2Since this study measured viral excretion starting from the first exposure all the way to 12 days after the last contact, does that mean the standard quarantine window I've heard about is still considered accurate, or has newer data changed that recommendation?
3This trial is now completed — has my doctor seen or can they point me to the published findings, and do those results affect any guidance they'd give me about monitoring for infection after a known COVID-19 exposure?
4Because this was a Phase N/A observational study rather than a treatment trial, it was measuring what naturally happens during infection rather than testing a therapy — does my doctor think the findings are relevant to decisions about testing timing or return-to-work guidance in my specific situation?
5If I or a family member has had a high or moderate risk contact with someone who had COVID-19, what does my doctor recommend I actually do right now — and does the evidence from studies like this one inform that advice?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to SARS-CoV-2 nasopharyngeal excretion, from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.
Timeframe: 12 days (+/-2)
Trial details
NCT IDNCT04259892
SponsorInstitut National de la Santé Et de la Recherche Médicale, France