Hydroxychloroquine with or without Azithromycin for the Treatment of COVID-19 Infection

PRIMARY OBJECTIVE:

I. Determine change in viral load at day 6 compared to baseline between two regimens to treat COVID-19 and a contemporaneous control group.

SECONDARY OBJECTIVES:

I. Time to resolution of symptoms (symptom questionnaire).

II. Change in the fever curve resulting in shorter time to afebrile for 48 hours.

III. Normalization of vital signs.

IV. Time to discharge (if hospitalized).

V. Assessment of agent toxicity as measured by standard metrics.

VI. Collection of throat swabs and blood for viral load, presence of IgM or IgG antibodies.

VII. If feasible on samples collected for quantitative polymerase chain reaction (PCR) decrease in virus shedding (in oropharyngeal secretions).

VIII. Measures of cytokines in blood including IL6, IL-8, TNF, INF.

IX. Routine standard of care labs obtained as part of the care of these patients such as differential white count, C-reactive protein (CRP), troponin and liver function test (LFT)s will be analyzed for correlative trends.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM 1: Patients receive hydroxychloroquine sulfate orally (PO) three times daily (TID) on days 1-10 and azithromycin monohydrate PO once daily (QD) on days 1-5 in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive hydroxychloroquine sulfate PO TID on days 1-10 in the absence of disease progression or unacceptable toxicity.

ARM 3: Patients receive placebo PO TID on days 1-6 and then receive hydroxychloroquine sulfate PO TID for 10 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 6 months.