Outcomes Related to COVID-19 Treated with Hydroxychloroquine among In-patients with Symptomatic Disease

About this Study

Blinded, multicenter, placebo-controlled randomized clinical trial of Hydroxychloroquine, which is given 400 mg twice daily for two doses (Day 1), then 200 mg twice daily for the subsequent eight doses (Days 2 – 5).

Sponsor Protocol ID:ORCHID
IRB Number:2020-0085
Closed for Enrollment
Interventional
Early Phase 1
Eligibility Criteria
18 years old
Both Male and Female
No
No
No

Inclusion Criteria(1) ≥18 years of age; 
(2) Currently hospitalized or in ED with anticipated hospitalization; 
(3) Symptoms of acute respiratory infection; 
(4) Lab-confirmed SARS-CoV-2 infection within the past 10 days or lab test result pending plus a high suspicion for COVID-19 as indicated by all of the following:  (a) Cough with duration ≤10 days; (b) Bilateral pulmonary infiltrates on chest imaging or new hypoxemia; (c) No alternative explanation for symptoms.

Exclusion Criteria(1) Pregnancy or breastfeeding; 
(2) Unable to randomize within 10 days after onset of acute respiratory infection symptoms; 
(3) Unable to randomize within 48 hours after hospital arrival; 
(4) seizure disorder; 
(5) Porphyria cutanea tarda; 
(6) QTc >500 ms on ECG within 72 hours prior to enrollment; and
(7) Long QT syndrome.

(Protocol silent on dual enrollment).

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COVID-19 (Coronavirus)
Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Lucia Solis
Phone Number: 601-815-3008
Email: solis@umc.edu
Principal Investigator:Jones, Alan E, M.D.
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