Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Open Label, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Mild Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus

Conditions
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Covid-19

Intervention / Treatment
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* Drug: Hydroxychloroquine Sulfate
* Drug: Azithromycin Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent from patient or legal representative. Male or female, and: aged ≥ 70 years; or aged < 70 with associated risk factors (chronic obstructive pulmonary disease; heart failure, immunosuppressed, obesity (BMI ≥ 35) uncontrolled diabetes and uncontrolled systemic arterial hypertension) 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: Participating in another RCT in the past 12 months; Known allergy to HCQ or chloroquine Any contraindication to HTC or AZT, including retinopathy and prolonged QT, Severely reduced LV function Severely reduced renal function; Pregnancy or breast feeding Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCQ + AZT<br>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. | Drug: Hydroxychloroquine Sulfate<br>* 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.<br>* Other names: Reuquinol;Drug: Azithromycin Tablets<br>* All patients included in the study will receive AZT 500 mg per day for 5 days.<br>* Other names: Azithromycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Condition | Ordinal scale (7 points ordinal scale that measures illness severity over time) | 28 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |