Status:
UNKNOWN
COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir
Lead Sponsor:
Unity Health Toronto
Conditions:
Coronavirus Infections
Post-exposure Prophylaxis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
COVID-19 has rapidly evolved into a generalized global pandemic. Post-exposure prophylaxis (PEP) against on COVID-19 was identified as an urgent research priority by the WHO, and lopinavir/ritonavir (...
Eligibility Criteria
Inclusion
- High risk close contact with a confirmed COVID-19 case during their symptomatic period, including one day before symptom onset, within the past 1-7 days. High risk close contact is defined as any of the following exposures without the consistent appropriate use of recommended personal protective equipment:
- Provided direct care for the index case
- Had close physical contact with the index case
- Lived with the index case
- Had close contact (within 2 metres), without direct physical contact, for a prolonged period of time
- Had direct contact with infectious body fluids, including oral secretions, respiratory secretions, or stool.
- Successfully contacted by the study team within 24 hours of study team notification of the relevant index COVID-19 case. This time window is necessary because the efficacy of PEP may be dependent on the timing of its initiation, and because randomization of a ring cannot be delayed while awaiting response from contacts that cannot be rapidly reached.
- Age ≥6 months, since the safety and pharmacokinetic profiles of LPV/r in pediatric patients below the age of 6 months have not been established.
- Ability to communicate with study staff in English
Exclusion
- Known hypersensitivity/allergy to lopinavir or ritonavir.
- Current use of LPV/r for the treatment or prevention of HIV infection.
- 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).
- 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.
- Current breastfeeding, due to potential for serious adverse reactions in nursing infants exposed to LPV/r
- 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
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT04321174
Start Date
April 17 2020
End Date
March 31 2022
Last Update
December 14 2021
Active Locations (4)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
2
Sunnybrook Hospital
Toronto, Ontario, Canada, M4N 3M5
3
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
4
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2