Methods |
Drug name: lopinavir ritonavir, ascorbic acid Trial design: parallel, randomised, blinded trial Identifier: PACTR202007700757139 Target sample size: 420 participants Planned completion date: July 2021 |
Participants |
Setting
Eligibility criteria
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Inclusion criteria
Men or women 18 to 80 years, inclusive, at the time of signing the informed consent
Willing and able to provide informed consent
Laboratory‐confirmed SARS‐CoV‐2 infection, with test results within past 72 hours
At increased risk of developing severe COVID‐19 disease
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Exclusion criteria
Known hypersensitivity to any of the study drugs
Currently hospitalised
Signs of respiratory distress prior to randomisation, including respiratory rate > 24 breath/minute and/or SpO2 < 93%
Chronic kidney disease (stage IV or receiving dialysis)
Known liver disease or cirrhosis
Known personal or family history of long QT syndrome
Taking chronic medications associated with prolonged QT and may induce Torsades de Pointes as per CredibleMeds.org, including certain antipsychotic medications or antidepressants (e.g. citalopram, venlafaxine, and bupropion) and unable to stop during the trial
Baseline QTc interval of > 470 ms in men, and > 480 ms in women if indicated by the safety profile of the investigational product
Potentially clinically significant pharmacokinetic and pharmacodynamic drug interactions as determined by the study clinical pharmacologist
Currently participating in a clinical trial currently or within 30 days of randomisation
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Interventions |
Intervention
Comparator
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Outcomes |
Efficacy outcomes:
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All‐cause mortality
Clinical progression/improvement of symptoms: not planned
Admission to hospital (for outpatients only): planned
Length of hospital stay (for those admitted to hospital): not planned
Admission to ICU: not planned
Length of ICU stay: not planned
Quality of life, including fatigue: not planned
Viral clearance: planned
Safety outcomes
Additional study outcomes
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Notes |
Funding: University of Washington |