Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19
NCT ID: NCT04372628
Last Updated: 2024-02-28
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
452 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-06-01
Study Completion Date
2022-01-18
Brief Summary
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Blinded, multicenter, placebo-controlled, randomized clinical trial evaluating lopinavir/ritonavir vs placebo in early outpatient treatment of adults with COVID-19
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Detailed Description
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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.
Conditions
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COVID-19
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
Blinded, multicenter, placebo-controlled randomized clinical trial
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Lopinavir/Ritonavir tablets or unmatched placebo tablets
Study Groups
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Group 1 - Lopinavir/Ritonavir
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Group Type
ACTIVE_COMPARATOR
Lopinavir/Ritonavir 400 mg/100 mg
Intervention Type
DRUG
Lopinavir/Ritonavir tablets
Control Group
Placebo unmatched orally twice daily for 14 days
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
Unmatched placebo
Interventions
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Lopinavir/Ritonavir 400 mg/100 mg
Lopinavir/Ritonavir tablets
Intervention Type
DRUG
Placebo
Unmatched placebo
Intervention Type
OTHER
Other Intervention Names
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Kaletra
Eligibility Criteria
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Inclusion Criteria
1. Age ≥18 years
2. 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
3. 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.
2. 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
3. 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.
Exclusion Criteria
1. Prisoner
2. Pregnancy
3. Breast feeding
4. Two individuals from the same household are not enrolled in the study
5. Unable to randomize within 6 days after onset of acute respiratory infection symptoms
6. Hospitalization within the 6 days prior to randomization
7. Inability to swallow oral medications
8. Refusal or inability to be contacted and participate in daily symptom/safety monitoring in English or Spanish during the two-week follow-up period
9. Previous enrollment in this trial
10. Known severe chronic kidney disease requiring dialysis
11. Known severe liver disease \[cirrhosis or \>3 times upper limit of normal for aspartate aminotransferase (AST) or alanine aminotransferase (ALT) in medical record if available\]
12. Known hepatitis B or hepatitis C infection
13. Known history of jaundice
14. Current heavy alcohol use, defined as 8 drinks or more per week for women or 15 drinks or more per week for men
15. Known seizure disorder
16. Known human immunodeficiency virus (HIV) infection
17. Known history of pancreatitis
18. Known history of prolonged QT interval \[Long QT Syndrome, patient report, or corrected QT interval (QTc) \>500 milliseconds on most recently available electrocardiogram within the past 2 years\]
19. Receipt of \>1 dose of lopinavir/ritonavir in the 10 days prior to enrollment
20. Known allergy to lopinavir/ritonavir
21. 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
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, 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.
2. Pregnancy
3. Breast feeding
4. Two individuals from the same household are not enrolled in the study
5. Unable to randomize within 6 days after onset of acute respiratory infection symptoms
6. Hospitalization within the 6 days prior to randomization
7. Inability to swallow oral medications
8. Refusal or inability to be contacted and participate in daily symptom/safety monitoring in English or Spanish during the two-week follow-up period
9. Previous enrollment in this trial
10. Known severe chronic kidney disease requiring dialysis
11. Known severe liver disease \[cirrhosis or \>3 times upper limit of normal for aspartate aminotransferase (AST) or alanine aminotransferase (ALT) in medical record if available\]
12. Known hepatitis B or hepatitis C infection
13. Known history of jaundice
14. Current heavy alcohol use, defined as 8 drinks or more per week for women or 15 drinks or more per week for men
15. Known seizure disorder
16. Known human immunodeficiency virus (HIV) infection
17. Known history of pancreatitis
18. Known history of prolonged QT interval \[Long QT Syndrome, patient report, or corrected QT interval (QTc) \>500 milliseconds on most recently available electrocardiogram within the past 2 years\]
19. Receipt of \>1 dose of lopinavir/ritonavir in the 10 days prior to enrollment
20. Known allergy to lopinavir/ritonavir
21. 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
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, 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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AbbVie
INDUSTRY
Sponsor Role
collaborator
Vanderbilt University Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Todd Rice
Associate Professor of Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Todd Rice, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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University of Colorado School of Medicine
Aurora, Colorado, United States
Site Status
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Site Status
University of Mississippi Medical Center
Jackson, Mississippi, United States
Site Status
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Site Status
Intermountain
Murray, Utah, United States
Site Status
University of Wisconsin
Madison, Wisconsin, United States
Site Status
Countries
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United States
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BACKGROUND
Kaizer AM, Shapiro NI, Wild J, Brown SM, Cwik BJ, Hart KW, Jones AE, Pulia MS, Self WH, Smith C, Smith SA, Ng PC, Thompson BT, Rice TW, Lindsell CJ, Ginde AA. Lopinavir/ritonavir for treatment of non-hospitalized patients with COVID-19: a randomized clinical trial. Int J Infect Dis. 2023 Mar;128:223-229. doi: 10.1016/j.ijid.2022.12.028. Epub 2022 Dec 27.
Reference Type
DERIVED
Kaizer AM, Wild J, Lindsell CJ, Rice TW, Self WH, Brown S, Thompson BT, Hart KW, Smith C, Pulia MS, Shapiro NI, Ginde AA. Trial of Early Antiviral Therapies during Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19: a summary of the protocol and analysis plan for a decentralized randomized controlled trial. Trials. 2022 Apr 8;23(1):273. doi: 10.1186/s13063-022-06213-z.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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https://apps.who.int/iris/handle/10665/330680
World Health Organization (WHO). WHO R\&D Blueprint: informal consultation on prioritization of candidate therapeutic agents for use in novel coronavirus 2019 infection, Geneva, Switzerland, 24 January 2020. \[Internet\]. \[cited 2020 Mar 19\]
https://www.crediblemeds.org/
Woosley R, Heise C, Gallo T, Tate J, Woosley D, Romero K. www.CredibleMeds.org, QTdrugs ListCredibleMeds \[Internet\]. \[cited 2020 Apr 24\]
http://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus/en/
WHO \| Coronavirus disease (COVID-2019) R\&D \[Internet\]. WHO. \[cited 2020 Mar 18\];
http://www.ncbi.nlm.nih.gov/books/NBK548738/
Hydroxychloroquine \[Internet\]. In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012 \[cited 2020 Mar 21\].
Other Identifiers
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200827
Identifier Type: -
Identifier Source: org_study_id
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MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b
NCT02845843
COMPLETED
PHASE2/PHASE3
Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)
NCT04575584
TERMINATED
PHASE2/PHASE3
Adaptive COVID-19 Treatment Trial (ACTT)
NCT04280705
COMPLETED
PHASE3
Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel
NCT04334928
COMPLETED
PHASE3
Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)
NCT04939428
COMPLETED
PHASE3
A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients
NCT04432766
WITHDRAWN
PHASE1/PHASE2
The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID)
NCT04405739
COMPLETED
PHASE2
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
NCT06667700
RECRUITING
PHASE3
A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia
NCT04255017
UNKNOWN
PHASE4
Randomised Evaluation of COVID-19 Therapy
NCT04381936
RECRUITING
PHASE3
Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease
NCT04344444
TERMINATED
PHASE3
AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
NCT05780437
COMPLETED
PHASE3
A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System
NCT05438602
COMPLETED
PHASE2
AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19
NCT04507256
COMPLETED
PHASE1
Early Intervention in COVID-19: Favipiravir Verses Standard Care
NCT04373733
COMPLETED
PHASE3