HOPE: A Trial of Hydroxichloroquine Plus Azithromycin in High Risk COVID-19

• Status: Withdrawn
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, double blind, randomized clinical trial for high-risk patients over 18 years of age, symptomatic for COVID-19 infection, without any severity criteria

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Latin American Cooperative Oncology Group
• Collaborator: Oncoclínicas
• Treatments: Azithromycin; Hydroxychloroquine

Criteria

Inclusion Criteria:

• Age ≥ 18 years and by 1 of the following criteria:

1. Cancer diagnosis and systemic antineoplastic treatment (chemotherapy or hormone therapy or immunotherapy or small molecule therapy), or having received the last dose within 90 days from randomization, or

2. Antineoplastic treatment with radiotherapy or had received the last fraction within 90 days from randomization, or

3. Undergone surgery for cancer treatment within 90 days from randomization, or

4. Need for continuous treatment for chronic disease. asthma, COPD, pulmonary fibrosis, pulmonary hypertension, smoking, systemic arterial hypertension, ischemic heart disease, hypertensive heart disease, symptomatic valve heart disease, cardiac arrhythmia, chronic renal failure, stroke, diabetes, autoimmune or other disease at the discretion of the investigator.

• Confirmed diagnosis of SARS-CoV-2 infection;

• Symptoms of SARS-Cov-2 (COVID-19) infection but without showing signs / symptoms of severity;

• Respiratory rate <24ipm;

• HR <130 bpm (in the absence of fever);

• Oxygen saturation > 90%