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Facing the challenge of finding an efficient treatment for COVID-19, the viral pneumonia caused by the Coronavirus SARS-Cov-2, this study intended to test if Chloroquine or Hydroxychloroquine, two drugs with strong in-vitro antiviral role proven by numerous studies and with a well defined safety profile established, for efficacy in treating COVID-19 and improving an ordinal primary outcome composed by a 9-levels scale, which was recomended by the World Health Organization.
This is a Phase 3, Pragmatic, Multicentric Randomized Controled Trial of efficacy to test the effect of either Chloroquine or Hydroxychloroquine for 5 days in the recomended dose standardized by brazilian Ministry of Health.
Patients were randomized (1:1) using stratified randomization by hospital and severity at the moment of randomization (stipulated by use of mechanical ventilation or not) into two arms: Intervention and Control. Intervention group recieved a loading dose of 900mg of Chloroquine or 800mg of Hydroxycloroquine in the first day, followed by 450mg of chloroquine of 400mg of hydroxychloroquine. Primary and secondary outcomes were evaluated on the 5th, 7th, 10th, 14th, 28th day after randomization.
Although the outcomes presented in the latest version were updated late on ClinicalTrials.org, on October 23, 2020, these outcomes were already present in the trial protocol approved by the Brazilian National Commission for Ethics in Research on April 8, 2020 (approval number: 3960331) and amending the protocol, approved by the same National Commission on May 25, 2020 (approval number: 4044848)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Treatment with either Chloroquine or Hydroxychloroquine according to what was available in the hospital: Chloroquine - 900mg on the first day, followed by 450mg in the next 4 days. Hydroxychloroquine - 800mg on the first day, followed by 450mg in the next 4 days. + Standard treatment available and recomended by the Brazilian Guidelines for COVID-19. |
|
| Control | Active Comparator | Standard treatment available and recomended by the Brazilian Guidelines for COVID-19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroquine | Drug | 5 days of treatment with Chloroquine + Standard Care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization (WHO) 9-levels ordinal scale (from 0-8) | Evaluation of the clinical status of patients on the 14th day after randomization defined by the 9-levels ordinal scale, with lower scores meaning better outcomes. | 14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization (WHO) 9-levels ordinal scale (from 0-8) | Evaluation of the clinical status of patients on the 5th, 7th, 10th and 28th day after randomization defined by the 9-levels ordinal scale, with lower scores meaning better outcomes. | 5, 7, 10 and 28 days after randomization |
| Mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia | Safety outcome: Any kind of arrhythmia identified by the attending physician at the time of the intercurrence, confirmed by an electrocardiogram (ECG), sometime until the 28th day | 28 days after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Estudos e Pesquisa em Emergencias Clinicas e Terapia Intensiva | Curitiba | Paraná | 82530200 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33907251 | Derived | Rea-Neto A, Bernardelli RS, Camara BMD, Reese FB, Queiroga MVO, Oliveira MC. An open-label randomized controlled trial evaluating the efficacy of chloroquine/hydroxychloroquine in severe COVID-19 patients. Sci Rep. 2021 Apr 27;11(1):9023. doi: 10.1038/s41598-021-88509-9. |
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Two arms - Intervention and Control Intervention received unblinded treatment with Chloroquine or Hyroxycloroquine for 5 days, as well as standard treatment available and recomended by the Brazilian Guidelines for COVID-19.
Control group received just the standard treatment available and recomended by the Brazilian Guidelines for COVID-19.
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| Hydroxychloroquine |
| Drug |
5 days of treatment with Hydroxychloroquine + Standard Care |
|
| standard care | Other | Standard Care according to Brazilian Guidelines for treating COVID-19 |
|
All-cause mortality at 28 days after randomization |
| 28 days after randomization |
| Ventilation free days | Number of days without need of Mechanical Ventilation at 28 days after randomization | 28 days after randomization |
| ICU Lenght of Stay | ICU Lenght of Stay on survivors at 28 days after randomization | 28 days after randomization |
| Hospital Lenght of Stay | Hospital Lenght of Stay on survivors at 28 days after randomization | 28 days after randomization |
| Acute Kidney Disease incidence | Acute Kidney Disease incidence measured by Kidney Disease Improving Global Outcomes (KDIGO) stage 3 sometime until the 28th day after randomization. | 28 days after randomization |
| Percentage of patients needing dialysis | Percentage of patients needing dialysis sometime until the 28th day. | 28 days after randomization |
| Coagulopathy incidence | Presence of coagulopathy sometime until the 28th day (platelets < 150000 and/or INR >1.5 and/or KPTT > 35 seconds). | 28 days after randomization |
| Mean of C Reactive Protein Levels | Mean of C Reactive Protein Levels on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization | 5, 7, 10, 14 and 28 days after randomization |
| Sequential Organ Failure Assessment (SOFA) scores | Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization. | 5, 7, 10, 14 and 28 days after randomization |
| Neutrophils/lymphocytes ratio | Neutrophils/lymphocytes ratio on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization. | 5, 7, 10, 14 and 28 days after randomization |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D006886 | Hydroxychloroquine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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