Cov-CONTACT: Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection. COVID-19.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Procedures added by the research:
Phone calls for collection of reported symptoms. Nasopharyngeal swabs for determination of the presence of SARS-CoV-2 detected by PCR.
Blood sampling for determination of the presence of SARS-CoV-2 IgM or IgG. Saliva or blood sampling for whole exome sequencing of the subject.
Study Design
Outcome Measures
Primary Outcome Measures
- 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. [12 days (+/-2)]
PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact
Secondary Outcome Measures
- Time to apparition of any symptom suggestive of SARS-CoV-2 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. [12 days (+/-2)]
Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...)
- Factors associated with the time to SARS-CoV-2 nasopharyngeal excretion [12 days (+/-2)]
nasopharyngeal excretion assessed by PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact
- Factors associated with the time to apparition of any symptom suggestive of SARS-CoV-2 infection [12 days (+/-2)]
Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...)
- Proportion of contact subjects with apparition of any symptom suggestive of SARS-CoV-2 infection [12 days (+/-2)]
Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...)
- Proportion of contact subjects with positive serology defined as the presence of SARS-CoV-2 IgM or IgG at day 30 (+/-7) following last contact [30 days (+/-7)]
ELISA, microneutralisation essay
- Host genetic variants [1 day]
Whole exome sequencing
- The time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology. [365 days (+/-30)]
ELISA, microneutralisation essay
Eligibility Criteria
Criteria
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.
Exclusion Criteria:
-
Subject deprived of freedom
-
Subject under a legal protective measure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon | Besançon | France | 25030 | |
| 2 | Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin | Bordeaux | France | 33076 | |
| 3 | Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand | Clermont-Ferrand | France | 63000 | |
| 4 | Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne | Dijon | France | 21 079 | |
| 5 | Centre d'investigation clinique 1406 CHU Grenoble | Grenoble | France | 38043 | |
| 6 | Centre d'Investigation Clinique 1403 -CHU Lille | Lille | France | 59037 | |
| 7 | Centre Investigation Clinique 1433 CHRU de NANCY | Nancy | France | 54511 | |
| 8 | Centre d'Investigation Clinique Hôpital Saint Louis | Paris | France | 75010 | |
| 9 | Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard | Paris | France | 75018 | |
| 10 | Centre Investigation Clinique 1417 Hôpital Cochin Bâtiment Lavoisier | Paris | France | 75679 | |
| 11 | Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou | Rennes | France | 35033 | |
| 12 | Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord | Saint Denis | France | 97400 | |
| 13 | Centre d'Investigation Clinique Ile de la Réunion CHU sud | Saint-Pierre | France | 97448 | |
| 14 | Département maladie infectieux CHU Saint Etienne | Saint-Étienne | France | 42055 | |
| 15 | Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau | Tours | France | 37000 | |
| 16 | Service de Maladies infectieuses et tropicales Centre hospitalier | Cayenne | French Guiana | 97306 |
Sponsors and Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
Investigators
- Principal Investigator: Xavier Duval, MD, Institut National de la Santé Et de la Recherche Médicale, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C20-06
- 2020-A00280-39