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Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.
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This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.
This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.
We aim to demonstrate decrease in hospital related complications among ambulatory patients with mild COVID-19 by treating them with HCQ and AZT on top of standard care compared to patients who receive standard care only.
Ambulatory patients on day 3 of symptoms and with confirmed diagnosis of COVID-19 will receive the treatment.
Patients that do not fulfill the inclusion/exclusion criteria or that is not willing to participate in the study will be invited to consent the use of their data as part of a "control" group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCQ + AZT | Experimental | All patients included in the study will receive hydroxychloroquine (HCQ) 400 mg (00 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (AZT) (500 mg/ 5 days) on top of standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine Sulfate | Drug | All patients included in the study will receive HCQ (400 mg BID on D1 and 400 mg/day on D2 to D7) for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Condition | Ordinal scale (7 points ordinal scale that measures illness severity over time) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization | Number of patients that needed to be hospitalized | 28 days |
| Change in Clinical Condition | Time for normalization of body temperature |
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Inclusion Criteria:
Informed consent from patient or legal representative.
Male or female, and:
One or more mild symptoms characteristic of COVID-19 for 3 days, such as fever, cough and signs of respiratory distress, which do not require hospitalization.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prevent Senior Private Operadora de Saúde LTDA. | São Paulo | Brazil |
It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
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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 |
|---|---|
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Azithromycin Tablets | Drug | All patients included in the study will receive AZT 500 mg per day for 5 days. |
|
|
| 28 days |
| Change in Clinical Condition | Time for normalization of of respiratory rate | 28 days |
| Change in Clinical Condition | Time for cough relief | 28 days |
| Rate of mortality within 28-days | Evaluation of change in acute respiratory syndrome | 28 days |
| Change in Clinical Condition related to comorbidity | Subgroup analysis by comorbidities | 28 days |
| 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 |