Status:
COMPLETED
Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
AbbVie
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Blinded, multicenter, placebo-controlled, randomized clinical trial evaluating lopinavir/ritonavir vs placebo in early outpatient treatment of adults with COVID-19
Detailed Description
We will conduct an investigator-initiated, multicenter, blinded, placebo-controlled, randomized clinical trial evaluating lopinavir/ritonavir vs placebo for early treatment of adults with COVID-19 in ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by reverse transcription polymerase chain reaction (RT-PCR) or other molecular test collected within the past 6 days
- Current symptoms of acute respiratory infection for ≤6 days, defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue.
Exclusion
- Prisoner
- Pregnancy
- Breast feeding
- Two individuals from the same household are not enrolled in the study
- Unable to randomize within 6 days after onset of acute respiratory infection symptoms
- Hospitalization within the 6 days prior to randomization
- Inability to swallow oral medications
- Refusal or inability to be contacted and participate in daily symptom/safety monitoring in English or Spanish during the two-week follow-up period
- Previous enrollment in this trial
- Known severe chronic kidney disease requiring dialysis
- Known severe liver disease \[cirrhosis or \>3 times upper limit of normal for aspartate aminotransferase (AST) or alanine aminotransferase (ALT) in medical record if available\]
- Known hepatitis B or hepatitis C infection
- Known history of jaundice
- Current heavy alcohol use, defined as 8 drinks or more per week for women or 15 drinks or more per week for men
- Known seizure disorder
- Known human immunodeficiency virus (HIV) infection
- Known history of pancreatitis
- Known history of prolonged QT interval \[Long QT Syndrome, patient report, or corrected QT interval (QTc) \>500 milliseconds on most recently available electrocardiogram within the past 2 years\]
- Receipt of \>1 dose of lopinavir/ritonavir in the 10 days prior to enrollment
- Known allergy to lopinavir/ritonavir
- Currently prescribed (with planned continuation) or planned administration during 14-day study period of medication at high risk for QT prolongation as follows:
- Antiarrhythmics: Amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol Anti-cancer: Arsenic trioxide, oxaliplatin, vandetanib Antidepressants: Amitriptyline, citalopram, escitalopram, imipramine Antimicrobials: azithromycin, ciprofloxacin, clarithromycin, erythromycin, fluconazole, levofloxacin, moxifloxacin, pentamidine, hydroxychloroquine Antipsychotics: haloperidol, chlorpromazine, droperidol, olanzapine, pimozide, quetiapine, thioridazine, risperidone, ziprasidone Others: cilostazol, cimetidine, cisapride, donepezil, methadone, ondansetron, sumatriptan
- Currently prescribed (with planned continuation) or planned administration during 14-day study period of any of the following medications: alfuzosin, apalutamide, astemizole, ergot-containing medicines (including dihydroergotamine mesylate, ergotamine tartrate, methylergonovine), lomitapide, lovastatin, lurasidone, midazolam, phenobarbital, phenytoin, ranolazine, rifampin, sildenafil, simvastatin, St. John's Wort, terfenadine, triazolam. Patients who are on warfarin or fluticasone will be advised to contact their primary care provider to advise them that they are in the trial and possibly receiving lopinavir/ritonavir which can influence levels of either drug and may require more frequent monitoring.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2022
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT04372628
Start Date
June 1 2020
End Date
January 18 2022
Last Update
February 28 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203