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This study was canceled before enrollment due to a decision by the Sponsor
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| Name | Class |
|---|---|
| Federal University of São Paulo | OTHER |
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The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Hydroxychloroquine (400 mg) |
|
| Group 2 | Experimental | Hydroxychloroquine (400 mg) + azithromycin (500 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine Sulfate | Drug | 400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Individual response rate | The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day. | 14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality rates at Day 28th after randomization | 28 days after randomization |
| Duration of mechanical ventilation | Number of days that the patient was on mechanical ventilation which was under ventilation from basal line |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of serious adverse events | Rates of serious adverse events | Day 14th |
Inclusion Criteria:
or
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apsen Farmacêutica S.A. | São Paulo | 04753-001 | Brazil |
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| Hydroxychloroquine Sulfate + Azythromycin | Drug | 400 mg, orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once a day, orally, for 10 days associated with azithromycin, intravenously or orally, 500 mg / day, for 1 day and then 250mg / day for another 4 days. |
|
|
| baseline |
| Proportion of patients which needed mechanical ventilation during study | Proportion of patients who do not receive mechanical ventilation at the beginning of the study and then needed mechanical ventilation during hospitalization. | hospitalization within 28 days |
| World Health Organization (WHO) Ordinal scale | The ordinal scale is an assessment of the clinical status at the first clinical evaluation in a clinical study. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. | 28 days after inclusion and compared to baseline |
| Duration of hospitalization | Length of hospital stay in days for hospitalization | hospitalization within 28 days |
| Rates of drug discontinuation | Rates of drug discontinuation in all causes under study | hospitalization within 28 days |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D045169 | Severe Acute Respiratory Syndrome |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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