COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir

Exclusion Criteria

• •1. Known hypersensitivity/allergy to lopinavir or ritonavir.
• •2. Current use of LPV/r for the treatment or prevention of HIV infection.
• •3. Receipt of LPV/r in the context of this trial or any other trial of COVID-19 PEP within 2 days or less prior to the last known contact with the index COVID-19 case. The two day time window is intended to ensure that exposure would not have occurred in the presence of clinically relevant drug levels (five times the elimination half-life of LPV/r, which is estimated at 4-6 hours with prolonged use).
• •4. Baseline respiratory tract specimen positive for COVID-19. Randomized participants whose baseline samples subsequently show COVID-19 will have study drug discontinued but still remain under observation.
• •5. Current breastfeeding, due to potential for serious adverse reactions in nursing infants exposed to LPV/r
• •6. Concomitant medications with prohibited drug interactions with LPV/r that cannot be temporarily suspended/replaced, including but not restricted to: 37
• •* alfuzosin (e.g. Xatral®)
• •* amiodarone (e.g. Cordarone™)
• •* apalutamide (e.g. Erleada™)
• •* astemizole\*, terfenadine\*
• •* cisapride\*
• •* colchicine, when used in patients with renal and/or hepatic impairment
• •* dronedarone (e.g., Multaq®)
• •* elbasvir/grazoprevir (e.g., ZepatierTM)
• •* ergotamine\* (e.g. Cafergot®\*), dihydroergotamine (e.g. Migranal®), ergonovine, methylergonovine\*
• •* fusidic acid (e.g., Fucidin®), systemic\*
• •* lurasidone (e.g., Latuda®), pimozide (e.g., Orap®\*)
• •* neratinib (e.g., Nerlynx®)
• •* sildenafil (e.g., Revatio®)
• •* triazolam (e.g. Halcion®), midazolam oral\*
• •* rifampin (e.g. Rimactane®\*, Rifadin®, Rifater®\*, Rifamate®\*)
• •* St. John's Wort
• •* Tadalafil (e.g. Adcirca®)
• •* venetoclax (e.g. Venclexta®)
• •* lovastatin (e.g., Mevacor®\*), lomitapide (e.g., JuxtapidTM) or simvastatin (e.g., Zocor®)
• •* vardenafil (e.g., Levitra® or Staxyn®)
• •* salmeterol (e.g., Advair® or Serevent®)
• •* denotes products not marketed in Canada