Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Hospitalized Patients With Moderate to Severe COVID-19

• Status: Suspended
• Trial end date: 2020-06-30
• 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 D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.

• 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, aged ≥ 18 years;

3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;

4. At least one of the characteristic symptoms of COVID-19

5. Hospitalized for up to 36h with non-invasive ventilation or up to 24h with invasive ventilation.

6. Negative result for pregnancy test (if applicable).

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