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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04259892
Other study ID # C20-06
Secondary ID 2020-A00280-39
Status Suspended
Phase
First received
Last updated
Start date February 4, 2020
Est. completion date December 4, 2022

Study information

Verified date July 2021
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 345
Est. completion date December 4, 2022
Est. primary completion date December 4, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. High/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case; 2. Within the 14 days following the last contact with a laboratory-confirmed SARS-CoV-2 case; 3. Obtaining informed consent. Exclusion Criteria: - Subject deprived of freedom - Subject under a legal protective measure

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
2019-nCoV PCR
Nasopharyngeal swabs

Locations

Country Name City State
France Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon Besançon
France Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin Bordeaux
France Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand Clermont-Ferrand
France Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne Dijon
France Centre d'investigation clinique 1406 CHU Grenoble Grenoble
France Centre d'Investigation Clinique 1403 -CHU Lille Lille
France Centre Investigation Clinique 1433 CHRU de NANCY Nancy
France Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard Paris
France Centre d'Investigation Clinique Hôpital Saint Louis Paris
France Centre Investigation Clinique 1417 Hôpital Cochin Bâtiment Lavoisier Paris
France Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou Rennes
France Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord Saint Denis
France Département maladie infectieux CHU Saint Etienne Saint-Étienne
France Centre d'Investigation Clinique Ile de la Réunion CHU sud Saint-Pierre
France Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau Tours
French Guiana Service de Maladies infectieuses et tropicales Centre hospitalier Cayenne

Sponsors (1)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

France,  French Guiana, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact 12 days (+/-2)
Secondary 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. 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, ...) 12 days (+/-2)
Secondary Factors associated with the time to SARS-CoV-2 nasopharyngeal excretion nasopharyngeal excretion assessed by PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact 12 days (+/-2)
Secondary Factors associated with the time to apparition of any symptom suggestive of SARS-CoV-2 infection 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, ...) 12 days (+/-2)
Secondary Proportion of contact subjects with apparition of any symptom suggestive of SARS-CoV-2 infection 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, ...) 12 days (+/-2)
Secondary 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 ELISA, microneutralisation essay 30 days (+/-7)
Secondary Host genetic variants Whole exome sequencing 1 day
Secondary The time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology. ELISA, microneutralisation essay 365 days (+/-30)
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