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Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19 | Clinical Trials | Clareo Health

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

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

NCT04372628•Vanderbilt University Medical Center

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+13 more criteria

Locations (6)

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

Intermountain

Murray, Utah, United States

University of Wisconsin

Madison, Wisconsin, United States

Key Dates

Start Date

June 1, 2020

Primary Completion Date

December 16, 2021

Completion Date

January 18, 2022

Last Updated

February 28, 2024

Enrollment

452

ACTUAL participants

Conditions

COVID-19

Interventions

Lopinavir/Ritonavir 400 mg/100 mg

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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