Trial of Early Antiviral Therapies during Non hospitalized Outpatient Window (TREAT NOW) for COVID-19

About this Study

A study to evalute the efficacy of Lopinavir/Ritonavir (Kaletra) for treatment of COVID-19. 

Sponsor Protocol ID:pending
IRB Number:pending
Actively Enrolling
Interventional
Early Phase 1
July 21, 2020
Eligibility Criteria
18 years old
Both Male and Female
No
No
No

Inclusion Criteria
1. Age ≥18 years

2. Laboratory-confirmed SARS-CoV-2 infection by RT-PCR or other molecular test within the past 6 days

3. Current symptoms of acute respiratory infection for ≤6 days, defined as one or more of the following:
o cough
o fever
o shortness of breath
o chest pain
o abdominal pain
o nausea/vomiting
o diarrhea
o body aches
o weakness/fatigue

Exclusion Criteria
1. Hospitalization within the 6 days prior to randomization

2. Known severe chronic kidney disease requiring dialysis

3. Known liver disease

4. Known hepatitis B or hepatitis C infection

5. Known history of jaundice

6. Current heavy alcohol use, defined as 8 drinks or more per week for women or 15 drinks or more per week for men

7. Known seizure disorder

8. Known HIV infection

9. Known history of pancreatitis

10. Known history of prolonged QT interval (Long QT Syndrome, patient report, or QTc >500 milliseconds on most recently available 
electrocardiogram within the past 2 years)

11. Receipt of >1 dose of lopinavir/ritonavir in the 10 days prior to enrollment

12. 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: aloperidol, chlorpromazine, droperidol, olanzapine, pimozide, quetiapine, thioridazine, risperidone, ziprasidone
Others: cilostazol, cimetidine, cisapride, donepezil, methadone, ondansetron, sumatriptan

22. 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, rivaroxaban, 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.

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COVID-19 (Coronavirus)
Participating Locations
University Hospital
Contact Information
Contact Name: Jenna Davis
Phone Number: 601-815-5533
Email: jlmcdowell@umc.edu
Principal Investigator:Jones, Alan E, M.D.
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