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Coronavirus InfectionsPhase 3CORIPREV-LRNCT04321174

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

A Phase 3 study testing Lopinavir/ritonavir in people with Coronavirus Infections and Post-exposure Prophylaxis, run by Unity Health Toronto at 4 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 (LPV/r) is a promising candidate for both COVID-19 treatment and PEP, with a good safety profile and global… Read more about this study

Who is it for?
Ages 18 months and older
What is being tested?
Lopinavir/ritonavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
4 sitesCanada
Study dates
17 Apr 2020to 31 Mar 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

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 (LPV/r) is a promising candidate for both COVID-19 treatment and PEP, with a good safety profile and global availability. This is a cluster randomized controlled trial (RCT) of oral LPV/r as PEP against COVID-19, that will address the immediate need for preventive interventions, generate key data on COVID-19 transmission, and serve as a research platform for future vaccines and preventive agents.

Being tested
Lopinavir/ritonavir
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lopinavir/ritonavirDrug

    Also called Kaletra, Aluvia

    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.

Study groups in NCT04321174
Study groupRoleWhat they receive
Lopinavir/ritonavirExperimentalThis arm will receive oral lopinavir/ritonavir 400/100 mg (or equivalent weight-based dosing) twice daily for 14 days.
Receives: Drug: Lopinavir/ritonavir
ControlNo interventionThis arm will receive no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbiologic evidence of infection

    The primary outcome is microbiologically confirmed COVID-19 infection, ie. detection of viral RNA in a respiratory specimen (mid-turbinate swab, nasopharyngeal swab, sputum specimen, saliva specimen, oral swab, endotracheal aspirate, bronchoalveolar lavage specimen) by day 14 of the study.

    Measured: 14 days

Secondary outcomes (9)

  1. Adverse events

    1. Adverse events: as defined using the DAIDS Table for Grading the Severity of Adverse Events, at 7, 14, 28 \& 90 days

    Measured: 90 days

  2. Symptomatic COVID-19 disease

    fever, cough or other respiratory/ systemic symptoms (including but not limited to fatigue, myalgias, arthralgias, shortness of breath, sore throat, headache, chills, coryza, nausea, vomiting, diarrhea) by day 14 in a patient with laboratory confirmed infection, combined with microbiologic confirmation of COVID-19 infection in the participant.

    Measured: 14 days

  3. Seropositivity

    Reactive serology to SARS-CoV-2

    Measured: 28 days

  4. Days of hospitalization attributable to COVID-19 disease

    The number of days (or partial days) spent admitted to an acute care hospital will be tabulated both at day 28 and day 90

    Measured: 90 days

  5. Respiratory failure requiring ventilatory support attributable to COVID-19 disease

    The number of days (or partial days) requiring i) non-invasive and ii) endotracheal intubation with ventilation will be tabulated both at day 28 and day 90.

    Measured: 90 days

  6. Mortality

    Death attributable to COVID-19 disease and all-cause mortality

    Measured: 90 days

  7. Short-term psychological impact of exposure to COVID-19 disease

    Short-term psychological distress will be measured using the K10, with a standard cutoff score of ≥16.

    Measured: 28 days

  8. Long-term psychological impact of exposure to COVID-19 disease

    Long-term impact will be measured at day 90 using the Impact of Event Scale, a validated measure of traumatic stress response, using a standard cutoff score of ≥26

    Measured: 90 days

  9. Health-related quality of life

    Health-related quality of life will be measured using the EQ-5D-5L (EuroQol-5D). The EQ-5D consists of two pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The tool will be administered to participants at 1, 14, 28 and 90 days.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start17 Apr 2020
  3. Primary completion27 Aug 2021
  4. Study completion31 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04321174
Sponsor's protocol ID
CORIPREV-1
Acronym
CORIPREV-LR
Status last verified
Nov 2021
First submitted
18 Mar 2020
Last updated
14 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: TBA

Publications

  • 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.

    PubMed 33752741

  • 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.

    PubMed 33570583

  • 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.

    PubMed 33240091

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lopinavir/ritonavir in people with Coronavirus Infections and Post-exposure Prophylaxis, run by Unity Health Toronto at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiologic evidence of infection (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321174, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.

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