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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001273-73 | EudraCT Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The Investigators propose to set up a preventive trial of infection in hospital workers at risk of coronavirus infection by comparing the rate of SARS-Cov-2 infection in a population of negative SARS-Cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a Placebo
Randomized clinical trial with 3 arms : hydroxychloroquine group, 300 subjects/azithromycin group, 300 subjects/ placebo of hydroxychloroquine group, 300 subjects. Hospital workers workers will be invited to participate in the study in each hospital and they will be included after giving their consent, assessment of their eligibility criteria, endonasal PCR and serolology at baseline. They will be randomized in one of the 3 arms, receive their treatment and will be followed by physical visit (at Day 2, Day 5, Day 15, Day 28) and by phone (at Day) 40 days with clinical data collection (tolerance and clinical signs of infection). At the end of treatment, another serology will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Title : hydroxychloroquine | Active Comparator | ||
| Placebo of hydroxychloroquine | Placebo Comparator |
| |
| azythromycin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydroxychloroquine | Drug | 200 mg BID per day | ||
| azithromycin |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of hydroxychloroquine and azithromycin on the prevention of SARS-CoV-2 contamination in hospital workers exposed to 40 days of treatment. | The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR | Clinical signs suggesting SARS-2 CoV infection confirmed by positive endonasal PCR | 40 days |
| Reducing seroconversion for SARS-CoV-2 without any clinical sign |
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Inclusion Criteria:
Hospital workers working at AP-HP hospitals over the age of 18
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Ma Treluyer, MD PhD | Assitance publique - Hôpitaux de Paris. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopial Avicenne | Bobigny | 93000 | France | |||
| Hôpital GHU Paris Saclay |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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250 mg per day |
|
| hydroxychloroquine placebo | Drug | 200 mg BID per day |
|
number of seroconversion by serology between Day 0 and Day 40.
| 3 months |
| Evaluation of drug tolerance in the study | number of cardiological severe adverse events assessed (ECG abnormalities : widening QT, ventricular arythmia, and cardiac arrests), other serious adverse events including hospitalizations, and deaths | 40 days |
| Evaluation on work stopping of hospital workers | Number of work stoppages over the period | 40 days |
| Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine | Plasmatic concentrations of treatments | 40 days |
| Incidence of cardiologic events | number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments | 40 days |
| Le Kremlin-Bicêtre |
| 92100 |
| France |
| Hôpital Saint Antoine | Paris | 75012 | France |
| Hôpital Broca | Paris | 75013 | France |
| Hôpital La Pitié-Salpétrière | Paris | 75013 | France |
| Hôpital Cochin | Paris | 75014 | France |
| Hôpital européen Georges Pompidou | Paris | 75015 | France |
| Hôpital Necker | Paris | 75015 | France |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |