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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:2020V0192
Study Status:

Study Status

Actively Enrolling: The study is currently recruiting participants.

Closed for Enrollment: The study is not currently recruiting participants.

Actively Enrolling
Study Type:

Study Type

Interventional: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

Observational: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.

Interventional
Study Phase:

Study Phase

Early Phase 1 Trials (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).

Phase 1 Trials: Trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.

Phase 2 Trials: Trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Phase 3 Trials: Trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Phase 4 Trials: Trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.

Early Phase 1
Online Start Date:

Online Start Date

The online start date is the day that this trial first appeared on the UMMC website, which is not necessarily the day that the trial first began at UMMC.

July 21, 2020
Eligibility Criteria
Minimum Age

Age Requirement

Studies may have specific age requirements. Some may only accept participants over a specified age and/or under a specified age. Please read the study description and additional eligibility criteria for specific information.

18 years old
Biological Sex

Biological Sex Requirement

Indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

 Both Male and Female
Cancer Related?

Cancer Related

Some studies may be targeted to cancer-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

No
Pediatric Related?

Pediatric Related

Some studies may be targeted to child-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

No
Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Indicates whether people who do not have the condition/disease being studied can participate in the clinical study.

Healthy volunteers play an important role in research because they help define "normal" ranges. While they may receive no direct benefit, healthy volunteers choose to participate in clinical research because they want to help others and contribute to advancing science.

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 - UMMC
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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