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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lopinavir/Ritonavir 400 mg/100 mg
Placebo
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • University of Colorado School of Medicine
  • Beth Israel Deaconess Medical Center
  • University of Mississippi Medical Center
  • Vanderbilt University Medical Center
  • Intermountain
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1 - Lopinavir/Ritonavir

Control Group

Arm Description

Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)

Placebo unmatched orally twice daily for 14 days

Outcomes

Primary Outcome Measures

Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial.

Secondary Outcome Measures

Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial.
Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group)
Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial.
Number of Patients Hospitalized: Day 1 to 29 (Group 2 and Placebo Control Group)
Number of patients hospitalized from Day 1 to 29 (Group 2 and Placebo Control Group)
Time to Hospitalization Day 1 to Day 29 (Group 2 and Placebo Control Group)
Number of days from enrollment to hospitalization (Group 2 and Placebo Control Group)
Time to Symptom Resolution: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Number of days from enrollment to resolution of COVID-19 symptoms (Group 2 and Placebo Control Group)
All-cause, All-location Mortality: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Survival status (All-cause, all-location mortality) from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Oxygen-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Number of Days without oxygen Day 1 to Day 29 (Group 2 and Placebo Control Group)
Fever-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Number of days without fever from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Ventilator-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Number of days without ventilator use from Day 1 to Day 29 (Group 2 and Placebo Control Group)
ICU-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Number of days outside the ICU from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Hospital-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Number of days outside the hospital from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Vasopressor-free Days Through Study Day 29 (Group 2 and Placebo Control Group)
Number of vasopressor-free days through Study Day 29 (Group 2 and Placebo Control Group)

Full Information

First Posted
April 30, 2020
Last Updated
January 9, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04372628
Brief Title
Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19
Acronym
TREATNOW
Official Title
Trial of Early Therapies During Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
January 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Coronavirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Blinded, multicenter, placebo-controlled randomized clinical trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
Lopinavir/Ritonavir tablets or unmatched placebo tablets
Allocation
Randomized
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Lopinavir/Ritonavir
Arm Type
Active Comparator
Arm Description
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Placebo unmatched orally twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir 400 mg/100 mg
Other Intervention Name(s)
Kaletra
Intervention Description
Lopinavir/Ritonavir tablets
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Unmatched placebo
Primary Outcome Measure Information:
Title
Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Description
Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial.
Time Frame
Day 1 to Day 15
Secondary Outcome Measure Information:
Title
Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
Description
Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial.
Time Frame
on or at Day 8
Title
Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group)
Description
Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial.
Time Frame
on or at Day 29
Title
Number of Patients Hospitalized: Day 1 to 29 (Group 2 and Placebo Control Group)
Description
Number of patients hospitalized from Day 1 to 29 (Group 2 and Placebo Control Group)
Time Frame
Day 1 to Day 29
Title
Time to Hospitalization Day 1 to Day 29 (Group 2 and Placebo Control Group)
Description
Number of days from enrollment to hospitalization (Group 2 and Placebo Control Group)
Time Frame
Day 1 to Day 29
Title
Time to Symptom Resolution: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Description
Number of days from enrollment to resolution of COVID-19 symptoms (Group 2 and Placebo Control Group)
Time Frame
Day 1 to Day 29
Title
All-cause, All-location Mortality: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Description
Survival status (All-cause, all-location mortality) from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Time Frame
Day 1 to Day 29
Title
Oxygen-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Description
Number of Days without oxygen Day 1 to Day 29 (Group 2 and Placebo Control Group)
Time Frame
Day 1 to Day 29
Title
Fever-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Description
Number of days without fever from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Time Frame
Day 1 to Day 29
Title
Ventilator-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Description
Number of days without ventilator use from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Time Frame
Day 1 to Day 29
Title
ICU-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Description
Number of days outside the ICU from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Time Frame
Day 1 to Day 29
Title
Hospital-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Description
Number of days outside the hospital from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Time Frame
Day 1 to Day 29
Title
Vasopressor-free Days Through Study Day 29 (Group 2 and Placebo Control Group)
Description
Number of vasopressor-free days through Study Day 29 (Group 2 and Placebo Control Group)
Time Frame
Day 1 to Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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 >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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Rice, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Intermountain
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19

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