drugset / Trial / NCT05026801
Azithromycin Plus Hydroxychloroquine for COVID-19 Infection
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a randomized, double-blinded, Phase 3, multi-center trial of the clinical and microbiologic response of patients with a respiratory tract infection (RTI) due to coronavirus treated with a combination of azithromycin and hydroxychloroquine. Approximately 200 patients with symptoms of an RTI who test positive for SARS-CoV-2 by polymerase chain reaction (PCR) will receive a combination of azithromycin 500 mg and hydroxychloroquine 600 mg or matching placebos for six consecutive days. There will be two treatment regimens into which patients are randomized so that all patients will receive some active therapy.
Timeline
- Start
- 2021-02-08
- Primary completion
- 2021-08-26
- Completion
- 2021-08-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azithromycin | Small molecule | 500 mg | Oral |
| Comparator | Hydroxychloroquine | Small molecule | 600 mg | Oral |