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Lopinavir/Ritonavir

Phase 4

COVID-19 | Small molecule | Infectious Disease |AbbVie Inc.|Trials Updated: Feb 28, 2024

Lopinavir/Ritonavir development status

Highest phase Phase 4 (NCT00648999)
Phase scored for ABBVPhase 2
Registered trials 58 across 15 sponsors since Aug 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment452

FDA Designations

No designations recorded

Lopinavir/Ritonavir clinical trials

Lopinavir/Ritonavir · 1 trial · 1 indication

Phase 2 1
NCT04372628Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19COVID-19
COMPLETED452 Analytics
PHASE2COMPLETED
Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19
COVID-19Unlock trial analytics

Study Endpoints

Primary Endpoints

Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Day 1 to Day 15

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 Endpoints

Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
on or at Day 8
Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group)
on or at Day 29
Number of Patients Hospitalized: Day 1 to 29 (Group 2 and Placebo Control Group)
Day 1 to Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1 - Lopinavir/RitonavirACTIVE_COMPARATORLopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Control GroupPLACEBO_COMPARATORPlacebo unmatched orally twice daily for 14 days

Interventions

NameTypeDescription
Lopinavir/Ritonavir 400 mg/100 mgDRUGLopinavir/Ritonavir tablets
PlaceboOTHERUnmatched placebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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...

Countries:United States
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