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

  • STATUS
    Recruiting
  • participants needed
    600
  • sponsor
    Vanderbilt University Medical Center
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Updated on 16 February 2024
See if I qualify
fever
dyspnea
PCR test
diarrhea
nausea
cough
fatigue
weakness
chest pain
covid-19
SARS
ritonavir
respiratory tract infection
coronavirus infection
lopinavir
lopinavir/ritonavir
vomit
ache
respiratory infection
acute respiratory infections
stomach pain
acute respiratory syndrome (sars)

Summary

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

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 the outpatient setting prior to hospitalization. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

Details
Condition Covid 19
Age 18years - 100years
Treatment Placebo, Lopinavir/Ritonavir 400 mg/100 mg
Clinical Study IdentifierNCT04372628
SponsorVanderbilt University Medical Center
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell

Exclusion Criteria

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 >5 times upper limit of normal for aspartate aminotransferase (AST) or alanine aminotransferase (ALT)]
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 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 hydroxychloroquine, chloroquine, or 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
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fever
dyspnea
PCR test
diarrhea
nausea
cough
fatigue
weakness
chest pain
covid-19
SARS
ritonavir
respiratory tract infection
coronavirus infection
lopinavir
lopinavir/ritonavir
vomit
ache
respiratory infection
acute respiratory infections
stomach pain
acute respiratory syndrome (sars)

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