Azithromycin Plus Hydroxychloroquine for COVID-19 Infection

NCT05026801 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: IT005-501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Tract Infection Viral

Keywords

Coronavirus

Outcome Measures

Primary Outcomes (1)

• Microbiologic response

  Presence or absence of SARS-CoV-2 by PCR on nasopharyngeal specimen

  Day 3 (+/- 1 day)

Secondary Outcomes (1)

• Combined clinical and microbiologic response

  Day 3 (+/- 1 day)

Study Arms (2)

Azithromycin plus hydroxychloroquine

ACTIVE COMPARATOR

Azithromycin 500 mg plus hydroxychloroquine 600 mg by mouth daily for six consecutive days

Drug: Azithromycin plus hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Azithromycin plus hydroxychloroquine

Interventions

Azithromycin plus hydroxychloroquine DRUG

All patients will receive active comparator. One group will receive placebo on D1-3 followed by active comparator D4-9, while the other group will receive active comparator D1-6 followed by placebo D7-9.

Also known as: Placebo

Azithromycin plus hydroxychloroquine; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age
• 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.
• A nasal or throat swab or nasal wash positive by PCR for SARS-CoV-2.
• 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.

You may not qualify if:

• Patients likely, in the opinion of the investigator, to require hospitalization within 48 hours of randomization into the study.
• Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in patients with an RTI
• Concurrent use of any other medications for the purpose of treating a viral infection such as influenza antivirals
• Inability to swallow oral medication in tablet form
• Patient has severe chronic kidney disease, or is receiving hemodialysis, or peritoneal dialysis or had a renal transplant
• Patient is known to have severe neutropenia
• Patients with a known prolongation of the QT interval or are taking medications which could prolong the QT interval
• Patient is known to be pregnant
• Patients with a known history of myasthenia gravis
• Patients with a history of allergy to azithromycin, hydroxychloroquine or chloroquine
• 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

Sponsors & Collaborators

• Iterum Therapeutics, International Limited: lead
• Waterbury Hospital: collaborator

Study Sites (1)

Waterbury Hospial

Waterbury, Connecticut, 06708, United States

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Azithromycin; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael Dunne, MD

  Iterum Therapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately 200 patients with symptoms of a RTI who test positive for SARS-CoV-2 by polymerase chain reaction (PCR) will receive a combination of azithromycin 500 mg and chloroquine 500 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. A sequential probability ratio test will be employed in which comparisons between each regimen will be made with every Day 3 PCR endpoint; if the p value crosses a p=0.001 threshold for any pairwise comparison, the less efficacious arm will be closed to further enrollment and superiority will be declared.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: August 30, 2021
• Study Start: February 8, 2021
• Primary Completion: August 26, 2021
• Study Completion: August 26, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 30 days of study completion.
• Access Criteria: Data access requests will be reviewed on a case by case basis. Requestors will be required to sign a Data Access Agreement.

Locations

US (1)