COVID-19Phase 2TREATNOWNCT04372628

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

A Phase 2 study testing Lopinavir/Ritonavir 400 mg/100 mg in people with COVID-19, run by Vanderbilt University Medical Center at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Blinded, multicenter, placebo-controlled, randomized clinical trial evaluating lopinavir/ritonavir vs placebo in early outpatient treatment of adults with COVID-19 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Lopinavir/Ritonavir 400 mg/100 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 452 participants
Where: 6 sitesUnited States
Study dates: 1 Jun 2020to 18 Jan 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 23Show fewer

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

University of Colorado School of Medicine
Aurora, Colorado, 80045
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Wisconsin
Madison, Wisconsin, 53705
Intermountain
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37203

Other trials in United States

About this study

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

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

Read the 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.

Conditions: COVID-19
Being tested: Lopinavir/Ritonavir 400 mg/100 mg, Placebo
Keywords: Coronavirus
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lopinavir/Ritonavir 400 mg/100 mgDrug
Also called Kaletra
Lopinavir/Ritonavir tablets
PlaceboOther
Unmatched placebo

Study groups in NCT04372628
Study group	Role	What they receive
Group 1 - Lopinavir/Ritonavir	Active comparator	Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14) Receives: Drug: Lopinavir/Ritonavir 400 mg/100 mg
Control Group	Placebo comparator	Placebo unmatched orally twice daily for 14 days Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1 to Day 15

Secondary outcomes (12)

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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1 to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202018 Jan 2022

First posted4 May 2020
Study start1 Jun 2020
Primary completion16 Dec 2021
Study completion18 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (36)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Blinded, multicenter, placebo-controlled randomized clinical trial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 452 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04372628
Sponsor's protocol ID: 200827
Acronym: TREATNOW
Status last verified: Feb 2024
First submitted: 30 Apr 2020
Last updated: 28 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Del Rio C, Malani PN. COVID-19-New Insights on a Rapidly Changing Epidemic. JAMA. 2020 Apr 14;323(14):1339-1340. doi: 10.1001/jama.2020.3072. No abstract available.
PubMed 32108857
Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. No abstract available.
PubMed 32109011
Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.
PubMed 32187464
Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4. No abstract available.
PubMed 32020029
Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
PubMed 31995857
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PubMed 31978945
Perlman S. Another Decade, Another Coronavirus. N Engl J Med. 2020 Feb 20;382(8):760-762. doi: 10.1056/NEJMe2001126. Epub 2020 Jan 24. No abstract available.
PubMed 31978944
Su S, Wong G, Shi W, Liu J, Lai ACK, Zhou J, Liu W, Bi Y, Gao GF. Epidemiology, Genetic Recombination, and Pathogenesis of Coronaviruses. Trends Microbiol. 2016 Jun;24(6):490-502. doi: 10.1016/j.tim.2016.03.003. Epub 2016 Mar 21.
PubMed 27012512
Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol. 2019 Mar;17(3):181-192. doi: 10.1038/s41579-018-0118-9.
PubMed 30531947
Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
PubMed 32015507
Cheng PK, Wong DA, Tong LK, Ip SM, Lo AC, Lau CS, Yeung EY, Lim WW. Viral shedding patterns of coronavirus in patients with probable severe acute respiratory syndrome. Lancet. 2004 May 22;363(9422):1699-700. doi: 10.1016/S0140-6736(04)16255-7.
PubMed 15158632
Hui DS, Azhar EI, Kim YJ, Memish ZA, Oh MD, Zumla A. Middle East respiratory syndrome coronavirus: risk factors and determinants of primary, household, and nosocomial transmission. Lancet Infect Dis. 2018 Aug;18(8):e217-e227. doi: 10.1016/S1473-3099(18)30127-0. Epub 2018 Apr 18.
PubMed 29680581
Wang Y, Liu Y, Liu L, Wang X, Luo N, Li L. Clinical Outcomes in 55 Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Who Were Asymptomatic at Hospital Admission in Shenzhen, China. J Infect Dis. 2020 May 11;221(11):1770-1774. doi: 10.1093/infdis/jiaa119.
PubMed 32179910
Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
PubMed 32167524
Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
PubMed 32191259

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trial of Early Therapies During Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19
ClinicalTrials.gov ID: NCT04372628
Acronym / sponsor ID: TREATNOW / 200827
Conditions: COVID-19
Keywords: Coronavirus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 452 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: AbbVie
Study start: 1 Jun 2020 (actual)
Primary completion: 16 Dec 2021 (actual)
Study completion: 18 Jan 2022 (actual)
First posted: 4 May 2020 (actual)
Results: Posted 26 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Blinded, multicenter, placebo-controlled randomized clinical trial

Arm	Type	Receives
Group 1 - Lopinavir/Ritonavir	Active comparator	Drug: Lopinavir/Ritonavir 400 mg/100 mgLopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Control Group	Placebo comparator	Other: PlaceboPlacebo unmatched orally twice daily for 14 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lopinavir/Ritonavir 400 mg/100 mgAlso: KaletraLopinavir/Ritonavir tablets	Drug	Group 1 - Lopinavir/Ritonavir
PlaceboUnmatched placebo	Other	Control Group

Primary outcome

Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Time frame: 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.

12 secondary outcomes

Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
Time frame: on or at Day 8
Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group)
Time frame: on or at Day 29
Number of Patients Hospitalized: 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)
Time frame: Day 1 to Day 29
Time to Symptom Resolution: Day 1 to Day 29 (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)
Time frame: Day 1 to Day 29
Oxygen-free Days: 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)
Time frame: Day 1 to Day 29
Ventilator-free Days: 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)
Time frame: Day 1 to Day 29
Hospital-free Days: 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)
Time frame: Day 1 to Day 29

Results and safety

Results posted to the registry on 26 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1- Hydroxychloroquine	4	3
Group 2 - Lopinavir/Ritonavir	221	216
Placebo Control Group	227	221

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

Time frame: Day 1 to Day 15. Count of participants. Unit: Participants

Measure	Group 2 - Lopinavir/Ritonavir n = 221	Placebo Control Group n = 227
Death	0	0
Hospitalized on Mechanical Ventilation/ECMO	1	0
Hospitalized on Supplemental Oxygen	5	4
Hospitalized, Not on Supplemental Oxygen	1	2
Not Hospitalized, Symptomatic, Limitations to Daily Activities	187	191
Not Hospitalized, Symptomatic, No Limitations to Daily Activities	10	14
Not Hospitalized, No Symptoms, No Limitations to Daily Activities	12	10
Unknown (no participant response)	5	6

Population analysed: Includes all randomized participants, Unknown represents those with no daily surveys submitted over the first 15 study days

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1- Hydroxychloroquine	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Group 2 - Lopinavir/Ritonavir	2 of 221 (0.9%)	203 of 221 (91.9%)	1 of 221
Placebo Control Group	1 of 227 (0.4%)	211 of 227 (93%)	0 of 227

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32108857Del Rio C, Malani PN. COVID-19-New Insights on a Rapidly Changing Epidemic. JAMA. 2020 Apr 14;323(14):1339-1340. doi: 10.1001/jama.2020.3072. No abstract available.
Background: PubMed 32109011Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. No abstract available.
Background: PubMed 32187464Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.
Background: PubMed 32020029Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4. No abstract available.
Background: PubMed 31995857Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
Background: PubMed 31978945Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
Background: PubMed 31978944Perlman S. Another Decade, Another Coronavirus. N Engl J Med. 2020 Feb 20;382(8):760-762. doi: 10.1056/NEJMe2001126. Epub 2020 Jan 24. No abstract available.
Background: PubMed 27012512Su S, Wong G, Shi W, Liu J, Lai ACK, Zhou J, Liu W, Bi Y, Gao GF. Epidemiology, Genetic Recombination, and Pathogenesis of Coronaviruses. Trends Microbiol. 2016 Jun;24(6):490-502. doi: 10.1016/j.tim.2016.03.003. Epub 2016 Mar 21.
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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. \[Internet\]. \[cited 2020 Mar 19\]Link provided by the sponsor.
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WHO \| Coronavirus disease (COVID-2019) R\&D \[Internet\]. WHO. \[cited 2020 Mar 18\];Link provided by the sponsor.
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 \[cited 2020 Mar 21\].Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Todd Rice, MD principal investigator

Vanderbilt University Medical Center

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lopinavir/Ritonavir 400 mg/100 mg in people with COVID-19, run by Vanderbilt University Medical Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group) (time frame: Day 1 to Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04372628, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.