Blinded, multicenter, placebo-controlled, randomized clinical trial evaluating lopinavir/ritonavir vs placebo in early outpatient treatment of adults with COVID-19
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
452
Lopinavir/Ritonavir tablets
Unmatched placebo
University of Colorado School of Medicine
Aurora, Colorado, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
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.
Time frame: Day 1 to Day 15
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.
Time frame: on or at Day 8
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.
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Intermountain
Murray, Utah, United States
University of Wisconsin
Madison, Wisconsin, United States
Time frame: on or at Day 29
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 frame: Day 1 to Day 29
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 frame: Day 1 to Day 29
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)
Time frame: Day 1 to Day 29
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)
Time frame: Day 1 to Day 29
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)
Time frame: Day 1 to Day 29
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)
Time frame: Day 1 to Day 29
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)
Time frame: Day 1 to Day 29
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)
Time frame: Day 1 to Day 29
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)
Time frame: Day 1 to Day 29
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)
Time frame: Day 1 to Day 29