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Currently COVID-19 is an international public health emergency. Most COVID-19 patients have mild or uncomplicated disease, but approximately 14% develop severe disease that requires hospitalization and oxygen therapy, and up to 5% of patients require admission to Intensive Care Units.
To date, the only treatments that have shown efficacy in a clinical trial are remdesivir and dexamethasone. The main objective is to provide reliable estimates on the effects of different treatment strategies on the outcome and mortality of patients with SARS-CoV-2 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main randomization.Arm: Emtricitabine / Tenofovir disoproxil fumarate | Experimental | Emtricitabine / Tenofovir disoproxil fumarate |
|
| Main randomization.Arm: No treatment | No Intervention | No treatment | |
| Rescue randomization: Arm: Dexamethasone + Baricitinib | Other | Rescue randomization: patients with oxygen requirements, O2 Sat <95% at any time, and at least one of the following inflammation markers: IL-6, CRP, D-dimer, LDH or ferritin above the upper limit of the normal range. Arms: Dexamethasone + Baricitinib or Dexamethasone. |
|
| Rescue randomization: Arm: Dexamethasone | Other | Rescue randomization: patients with oxygen requirements, O2 Sat <95% at any time, and at least one of the following inflammation markers: IL-6, CRP, D-dimer, LDH or ferritin above the upper limit of the normal range. Arms: Dexamethasone + Baricitinib or Dexamethasone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine/Tenofovir Disoproxil Fumarate 200 MG-245 MG Oral Tablet [TRUVADA] | Drug | Main randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | at 28 days |
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First randomization
Inclusion criteria.
Exclusion criteria.
Second randomization (if applicable):
Patients already included in the study and initially randomized may be re-randomized at any time if they present an O2 Sat <95% (need for oxygen therapy) and at least 1 marker of inflammation of the following: IL-6, CRP, D-Dimer , LDH, or ferritin above the upper limit of the normal range. This randomization can only be done in hospitalized patients. Patients will receive one of the following arms of treatment:
Exclusion criteria (rescue randomization):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
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| Label | URL |
|---|---|
| Related Info | View source |
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Main randomization. Patients will be randomized to Emtricitabine / Tenofovir disoproxil fumarate or no treatment.
Rescue randomization: patients with oxygen requirements, O2 Sat <95% at any time, and at least one of the following inflammation markers: IL-6, CRP, D-dimer, LDH or ferritin above the upper limit of the normal range. Arms:
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| Baricitinib + dexamethasone | Drug | Rescue randomization |
|
| Dexamethasone | Drug | Rescue randomization |
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C000596027 | baricitinib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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