Azithromycin Plus Hydroxychloroquine for COVID-19 Infection

• Status: Withdrawn
• Trial end date: 2021-08-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iterum Therapeutics, International Limited
• Collaborator: Waterbury Hospital
• Treatments: Azithromycin; Hydroxychloroquine

Criteria

Inclusion Criteria:

1. Adults ≥18 years of age

2. History of a respiratory tract infection (RTI) for more than one but less than six days including two or more of the following signs and symptoms of an RTI:

• Fever (T ≥ 38.0 C, 100.5 F), cough, sputum production, arthralgia/myalgia, anosmia/ageusia or difficulty breathing.

3. A nasal or throat swab or nasal wash positive by PCR for SARS-CoV-2.

4. Has given written informed consent to participate in the study. Due to the public health issues related to this viral infection, witnessed informed consent may be obtained remotely.

Exclusion Criteria:

Exclusion Criteria:

1. Patients likely, in the opinion of the investigator, to require hospitalization within 48 hours of randomization into the study.

2. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in patients with an RTI

3. Concurrent use of any other medications for the purpose of treating a viral infection such as influenza antivirals

4. Inability to swallow oral medication in tablet form

5. Patient has severe chronic kidney disease, or is receiving hemodialysis, or peritoneal dialysis or had a renal transplant

6. Patient is known to have severe neutropenia

7. Patients with a known prolongation of the QT interval or are taking medications which could prolong the QT interval

8. Patient is known to be pregnant

9. Patients with a known history of myasthenia gravis

10. Patients with a history of allergy to azithromycin, hydroxychloroquine or chloroquine

11. Patient is considered unlikely to survive the study period or has a rapidly progressive or terminal illness, including septic shock, associated with a high risk of mortality