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

• Status: Suspended
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Collaborator: PREVENT SENIOR PRIVATE OPERADORA DE SAÚDE LTDA
• Treatments: Azithromycin; Hydroxychloroquine

Criteria

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