Status:
WITHDRAWN
Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial
Lead Sponsor:
Kootenai Health
Collaborating Sponsors:
Washington State University
Conditions:
SARS-CoV-2 Pneumonia
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Novel coronavirus SARS(Severe Acute Respiratory Syndrome)-CoV-2 was first identified during the outbreak in Wuhan, China in December 2019 with the now resulting pandemic. Aggressive supportive care is...
Detailed Description
Novel coronavirus SARS-CoV-2 was first identified during the outbreak in Wuhan, China in December 2019 with the now resulting pandemic. Aggressive supportive care is the mainstay of treatment currentl...
Eligibility Criteria
Inclusion
- Age \> 18 years of age
- SARS-CoV-2 positive per FDA approved RT-PCR (reverse transcription-polymerase chain reaction)
- Acute hypoxia (O2 sat \< 90 % or paO2 \< 60 on room air), or above baseline chronic O2 requirement
- Inpatient admission
Exclusion
- Requires supplemental O2 \>10 litres per minute or mechanical ventilation on admission
- Pregnancy
- AST/ALT \> 5 times the upper limit normal
- Baseline prolonged QT
- Child-Pugh Score B or greater
- ESRD(end-stage renal disease) requiring dialysis
- Known allergy to medication component,
- History of severe G6PD (glucose-6-phosphate dehydrogenase)
- Myasthenia gravis
- Porphyria
- Ongoing treatment for epilepsy
- Life expectancy \< 6 months,
- Patient lacks capacity to provide consent and does not have a surrogate decision maker.
- Retinal Disease
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04382625
Start Date
October 1 2020
End Date
June 1 2022
Last Update
February 5 2021
Active Locations (1)
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1
Kootenai Health
Coeur d'Alene, Idaho, United States, 83814