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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality.
Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Early administration of tocilizumab associated with hydroxychloroquine and azithromycin. |
|
| Control | Active Comparator | Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | 162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | Through hospitalization, an average of 2 weeks | |
| Need for mechanical ventilation in the Intensive Care Unit | Through hospitalization, an average of 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pere Domingo, MD, PhD | Contact | pdomingo@santpau.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Principality of Asturias | Spain |
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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 |
|---|---|
| C502936 | tocilizumab |
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Hydroxychloroquine |
| Drug |
400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total) |
|
| Azithromycin | Drug | 500 mg / day v.o. for 3 days |
|
| Hospital General Universitario de Alicante | Recruiting | Alicante | Valencia | Spain |
|
| Hospital General Universitario de Elche | Recruiting | Elche | Valencia | Spain |
|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
|
| Hospital del Mar | Recruiting | Barcelona | Spain |
|
| Hospital Sant Joan DespĂ | Recruiting | Barcelona | Spain |
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| Hospital Clinico San Carlos | Recruiting | Madrid | Spain |
|
| 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 |