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This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | CQ 450mg twice daily (3 tablets of 150mg, every 12 hours) on day 1, followed by CQ 450mg once daily (3 tablets of 150mg) from D2 to D5. Oral administration. |
|
| Placebo | Placebo Comparator | Placebo tables of equal characteristics and duration of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroquine Diphosphate | Drug | 150mg tablets Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with onset of severe acute respiratory syndrome (SARS) | Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires. | 7 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization | after randomization, up to 28 days |
| Number of participants in need of intensive care support |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients with chronic use of drugs known to prolong QTc interval.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz | Manaus | Amazonas | 69093-415 | Brazil |
all patient data will be shared after study publication
after study publication
Upon formal request to researchers.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C023676 | chloroquine diphosphate |
| D002738 | Chloroquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Placebo oral tablet | Drug | 150mg placebo tablets |
|
Proportion of participants in need and duration of intensive care support after randomization
| during and after intervention, up to 28 days |
| Viral concentration | Viral load change in blood and oropharyngeal swab samples | After randomization, up to 7 days |
| Cumulative incidence of serious adverse events | Incidence of serious adverse events during and after treatment | During and after intervention, up to 28 days |
| Cumulative incidence of grade 3 and 4 adverse events | Incidence of grade 3 and 4 adverse events during and after treatment | During and after intervention, up to 28 days |
| Proportion of patients with discontinued treatment | proportion of discontinuation or temporary suspension of treatment (for any reason) | after randomization, up to 28 days |
| Incidence of cardiac lesions | proportion of patients with increased levels of troponin I | after randomization, up to 120 days |
| Incidence of cardiac disfunctions | proportion and magnitude of QTcF interval increases higher than 500ms | after randomization, up to 120 days |
| Change in respiratory capacity | Changes measured on day 120 will be compared to baseline, through spirometry. | Day 120 after randomization |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006571 | Heterocyclic Compounds |