COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir
NCT ID: NCT04321174
Last Updated: 2021-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
123 participants
INTERVENTIONAL
2020-04-17
2022-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lopinavir/ritonavir
This arm will receive oral lopinavir/ritonavir 400/100 mg (or equivalent weight-based dosing) twice daily for 14 days.
Lopinavir/ritonavir
The intervention is a 14-day course of LPV/r 400/100 mg orally twice daily, or equivalent weight-based dosing, to be initiated as soon as possible (within 1-7 days) after the last exposure.
Control
This arm will receive no intervention.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lopinavir/ritonavir
The intervention is a 14-day course of LPV/r 400/100 mg orally twice daily, or equivalent weight-based dosing, to be initiated as soon as possible (within 1-7 days) after the last exposure.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Provided direct care for the index case
2. Had close physical contact with the index case
3. Lived with the index case
4. Had close contact (within 2 metres), without direct physical contact, for a prolonged period of time
5. Had direct contact with infectious body fluids, including oral secretions, respiratory secretions, or stool.
2. 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.
3. 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.
4. Ability to communicate with study staff in English
Exclusion Criteria
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
18 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Unity Health Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Darrell Tan, MD FRCPC PhD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Paul's Hospital
Vancouver, British Columbia, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tan DHS, Chan AK, Juni P, Tomlinson G, Daneman N, Walmsley S, Muller M, Fowler R, Murthy S, Press N, Cooper C, Lee T, Mazzulli T, McGeer A. Post-exposure prophylaxis against SARS-CoV-2 in close contacts of confirmed COVID-19 cases (CORIPREV): study protocol for a cluster-randomized trial. Trials. 2021 Mar 22;22(1):224. doi: 10.1186/s13063-021-05134-7.
Akhtar S, Das JK, Ismail T, Wahid M, Saeed W, Bhutta ZA. Nutritional perspectives for the prevention and mitigation of COVID-19. Nutr Rev. 2021 Feb 11;79(3):289-300. doi: 10.1093/nutrit/nuaa063.
Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CORIPREV-1
Identifier Type: -
Identifier Source: org_study_id