Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

Blinded, multicenter, placebo-controlled, randomized clinical trial evaluating lopinavir/ritonavir vs placebo in early outpatient treatment of adults with COVID-19

Key facts

Study ID

NCT04372628

Run by

Vanderbilt University Medical Center

People needed

452

Starts

2020-06-01

Expected to finish

2022-01-18

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Colorado School of Medicine — Aurora, Colorado, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Intermountain — Murray, Utah, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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