COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir (CORIPREV-LR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04321174|
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infections Post-exposure Prophylaxis||Drug: Lopinavir/ritonavir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir|
|Actual Study Start Date :||April 17, 2020|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2022|
This arm will receive oral lopinavir/ritonavir 400/100 mg (or equivalent weight-based dosing) twice daily for 14 days.
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.
No Intervention: Control
This arm will receive no intervention.
- Microbiologic evidence of infection [ Time Frame: 14 days ]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.
- Adverse events [ Time Frame: 90 days ]a) Adverse events: as defined using the DAIDS Table for Grading the Severity of Adverse Events, at 7, 14, 28 & 90 days
- Symptomatic COVID-19 disease [ Time Frame: 14 days ]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.
- Seropositivity [ Time Frame: 28 days ]Reactive serology to SARS-CoV-2
- Days of hospitalization attributable to COVID-19 disease [ Time Frame: 90 days ]The number of days (or partial days) spent admitted to an acute care hospital will be tabulated both at day 28 and day 90
- Respiratory failure requiring ventilatory support attributable to COVID-19 disease [ Time Frame: 90 days ]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.
- Mortality [ Time Frame: 90 days ]Death attributable to COVID-19 disease and all-cause mortality
- Short-term psychological impact of exposure to COVID-19 disease [ Time Frame: 28 days ]Short-term psychological distress will be measured using the K10, with a standard cutoff score of ≥16.
- Long-term psychological impact of exposure to COVID-19 disease [ Time Frame: 90 days ]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
- Health-related quality of life [ Time Frame: 90 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321174
|Contact: Attia Qamar, BEng||416-864-6060 ext 77325||Attia.Qamar@unityhealth.to|
|Contact: Alex Schnubb||4168646060 ext 77105||Alexandre.Schnubb@unityhealth.to|
|Canada, British Columbia|
|St. Paul's Hospital||Not yet recruiting|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Contact: Natasha Press, MD 604-806-8642 email@example.com|
|Sunnybrook Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Adrienne Chan, MD MPH FRCPC firstname.lastname@example.org|
|St. Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada, M5B 1W8|
|Contact: Darrell Tan, MD PhD FRCPC 416-864-5568|
|Principal Investigator: Darrell Tan, MD PhD FRCPC|
|Toronto General Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2N2|
|Contact: Sharon Walmsley, MD 4163403871 email@example.com|
|Principal Investigator: Sharon Walmsley, MD|
|Principal Investigator:||Darrell Tan, MD FRCPC PhD||Unity Health Toronto|