COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04372628

Todd Rice, MD

todd.rice@vumc.org

2020-05-04

Completed

RCT

Randomized

Sequential assignment

Blind label

multi-center

Treatment

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.

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.

3

Vanderbilt University Medical Center

18

None

United States

Mild disease at enrollment

1: Mild disease at enrollment

452

Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)

None

Phase 2

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]