Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease

Inclusion Criteria:

1. Informed consent must be obtained prior to participation in the study

2. Adult patient ≥ 18 years old

3. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
polymerase chain reaction (PCR) test from respiratory tract specimen (e.g
nasopharyngeal swab)

4. Onset of signs and symptoms of COVID19 illness ≤ 7 days prior to randomization
(including but not limited to fever, cough, myalgias, fatigue, abnormal chest imaging)

5. Currently hospitalized or requiring hospitalization due to COVID-19 disease

Exclusion Criteria:

1. Use of other investigational drugs or newly approved COVID-19 treatments within 5-half
lives or 30 days of enrolment

2. History of hypersensitivity to any of the study treatments or its excipients or to
drugs of similar chemical classes

3. Participation in any other clinical trial of an experimental treatment for COVID-19

4. Expectation of concurrent treatment with any other agents or potential direct acting
antiviral activity against SARS-Co V-2 during study drug dosing

5. Requires, in the judgement of the investigator, admission to the intensive care unit
(ICU) or mechanical ventilatory support (invasive or non-invasive) prior to first dose
of study drug (There might be a patient who cannot be admitted to the ICU, even if the
patient's condition is severe enough, due to administrative reasons under the current
circumstances. This case is also considered under admission to the ICU judged by the
investigator)

6. Evidence of cytokine storm syndrome or multi-organ system failure

7. Confirmed co-infection with influenza

8. Creatinine clearance < 45 mL/min or requiring acute renal replacement therapy

9. History or current diagnosis of ECG abnormalities indicating significant risk of
safety for participants participating in the study

10. Any other condition which in the opinion of the investigator, would put the safety of
the participant at risk, impede compliance or hinder completion of the study

11. Pregnant or nursing (lactating) women

12. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they agree to use basic methods of contraception during
dosing of study treatment.