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

Early Phase 1SuspendedNCT04348474

Azidus Brasil200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Covid-19

Interventions

Hydroxychloroquine SulfateDRUG

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.

Azithromycin TabletsDRUG

All patients included in the study will receive AZT 500 mg per day for 5 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Informed consent from patient or legal representative. 2. Male or female, and: 1. aged ≥ 70 years; or 2. aged \< 70 with associated risk factors (chronic obstructive pulmonary disease; heart failure, immunosuppressed, obesity (BMI ≥ 35) uncontrolled diabetes and uncontrolled systemic arterial hypertension) 3. 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: 1. Participating in another RCT in the past 12 months; 2. Known allergy to HCQ or chloroquine 3. Any contraindication to HTC or AZT, including retinopathy and prolonged QT, 4. Severely reduced LV function 5. Severely reduced renal function; 6. Pregnancy or breast feeding 7. 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

Locations (1)

Prevent Senior Private Operadora de Saúde LTDA.

São Paulo, Brazil

Outcomes

Primary Outcomes

Change in Clinical Condition

Ordinal scale (7 points ordinal scale that measures illness severity over time)

Time frame: 28 days

Secondary Outcomes

Hospitalization

Number of patients that needed to be hospitalized

Time frame: 28 days

Change in Clinical Condition

Time for normalization of body temperature

Time frame: 28 days

Change in Clinical Condition

Time for normalization of of respiratory rate

Time frame: 28 days

Change in Clinical Condition

Time for cough relief

Time frame: 28 days

Rate of mortality within 28-days

Evaluation of change in acute respiratory syndrome

Time frame: 28 days

Change in Clinical Condition related to comorbidity

Subgroup analysis by comorbidities

Time frame: 28 days

Data from ClinicalTrials.gov

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