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

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

Status

Suspended

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04348474

Enrollment

200

Registered

2020-04-16

Start date

2020-04-20

Completion date

2023-07-31

Last updated

2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19

Brief summary

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

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.

Interventions

DRUGHydroxychloroquine Sulfate

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.

DRUGAzithromycin Tablets

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Hospitalization	28 days	Number of patients that needed to be hospitalized
Change in Clinical Condition	28 days	Time for normalization of body temperature
Rate of mortality within 28-days	28 days	Evaluation of change in acute respiratory syndrome
Change in Clinical Condition related to comorbidity	28 days	Subgroup analysis by comorbidities

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026