This is a prospective, randomized, double-blinded, placebo-controlled, pilot study to assess the preliminary efficacy and safety of hydroxychloroquine for the treatment of patients with lower respiratory tract SARS-CoV-2 infection.
A total of 40 participants are planned for enrollment. Those enrolled into this study will be randomized 1:1 to receive either hydroxychloroquine or placebo control. Participants will receive their study intervention for 5 days, after which they will be considered off protocol- directed therapy and receive medical management of their disease according to institutional standards. Participants may be followed for up to 180 days from initiating protocol therapy for clinical outcome, after which they will discontinue study participation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Hydroxychloroquine is more polar, less lipophilic, and has more difficulty diffusing across cell membranes than the parent compound, chloroquine. These characteristics result in hydroxychloroquine having a longer half-life, comparatively lower toxicity to chloroquine, as well as fewer concerns pertaining to drug-drug interactions
A placebo is a pill that looks like the study drug but has no real medicine in it.
Oregon Health and Science University
Portland, Oregon, United States
Clinical Status at Day 5 Assessed by a 6-Point Ordinal Scale
A 6-point ordinal scale ranging from "Death" to "Not hospitalized with full resumption of normal activities" is used to evaluate differences in the clinical status between participants that receive placebo vs hydroxychloroquine
Time frame: Day 5
Number of Participants with Detectable SARS-CoV-2 Virus from Day 0 to Day 28 and at Day 5
Assess differences in SARS-CoV-2 viral shedding between participants that receive placebo vs hydroxychloroquine
Time frame: Day 0 to Day 28 and at Day 5
Toxicity of Study Drug Assessed by Incidence of Adverse Events
Assess by incidence of Grade 3, Grade 4, and Serious Adverse Events (AEs)
Time frame: Day 0 to Day 28
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