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Hematopoietic and Lymphoid Cell NeoplasmPhase 2NCT04455958

Lopinavir/Ritonavir for the Treatment of COVID-19 Positive Patients With Cancer and Immune Suppression in the Last Year

A Phase 2 study testing Lopinavir/Ritonavir and Questionnaire Administration in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial studies how well lopinavir/ritonavir works in treating COVID-19 positive patients with cancer and a weakened immune system (immune-suppression) in the last year and have mild or moderate symptoms caused by COVID-19. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lopinavir/Ritonavir and Questionnaire Administration
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 May 2021to 1 Nov 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Ability to understand and the willingness to sign a written informed consent document
  • Participants with a diagnostically proven COVID-19 positive nasal swab test result within 14 days
  • Participants must have a diagnosis of cancer
  • Participants must be considered immune suppressed either due to their cancer diagnosis or due to treatment of their cancer. Participants must meet at least one of the following criteria:
  • Have received immune suppressing anti-cancer therapy in the past year (i.e., therapy that suppresses white blood cells and/or has been shown to be associated with infection, as stipulated in the drug package insert)
  • Have received intravenous immunoglobulin (IVIG) in the past year for treatment and/or prevention of recurrent infections
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  • Are within one year of an autologous bone marrow transplant or chimeric antigen receptor (CAR) T-cell therapy, or within five years of an allogeneic bone marrow transplant
  • Have been treated for three or more infections within the past 6 months
  • Have an absolute neutrophil count at or below 1,500 cells/mcL at some point within two months of the time of consent. This can be due therapy and/or due to cancer suppressing marrow function
  • Have a history of neutropenic fever in the past year
  • Presence of a chronic infection, e.g. tuberculosis (TB) or osteomyelitis, or within 3 months of treatment for such. Topical fungal infections of the skin are not included in this category
  • Participants with mild symptoms, must have had mild symptoms for no more than 2 weeks
  • Participants with moderate symptoms, must have had moderate symptoms for no more than 1 week
  • Pregnant or women of child-bearing potential may be treated if they have no documented lopinavir-associated resistance substitutions
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x upper limit of normal (ULN)
  • Total bilirubin =< 2 x ULN (individuals with higher values felt to be consistent with inborn errors of metabolism will be considered on a case-by-case basis)
  • Creatinine =< 2 x ULN
  • Participants with abnormal blood counts (white blood cell [WBC], platelet, hemoglobin [Hg]) will not be excluded

Who cannot join

  • Participants who do not develop mild to moderate symptoms within 28 days of test results
  • Participants with rapid clinical deterioration, in the opinion of the investigator
  • Participants experiencing severe symptoms according to COVID-19 Symptom Grading Tool
  • History of being human immunodeficiency virus (HIV) positive; by history only; participants do not need to confirm by testing
  • Participant has any other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, may cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol
  • Participants receiving any contraindicated medication that in the opinion of the investigator cannot be continued while receiving study drug and cannot be held for the duration of the 14-day study treatment period safely
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  • History of unstable cardiac disease in the past 6 months
  • History of prolonged QT interval, or on other cardiac medications known to prolong the QT interval
  • Use of strong inhibitors and inducers of CYP3A4 is prohibited. Lopinavir/ritonavir (L/R) is primarily metabolized by CYP3A4. Therefore, concomitant use of strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nelfinavir and saquinavir), and inducers of CYP3A (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, St. John's wort) are not permitted. The use of other herbals will be reviewed on a case-by-case basis. If they are deemed to be strong modulators of CYP3A4, patients will be excluded if they are unable or unwilling to stop taking them
  • Women who plan to breast feed while on this study are not eligible for participation due to the potential for unnecessary adverse event risks to a child

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled Phase II Study of Lopinavir/Ritonavir Versus Placebo in COVID-19 Positive Patients With Cancer and Immune Suppression in the Last Year

This phase II trial studies how well lopinavir/ritonavir works in treating COVID-19 positive patients with cancer and a weakened immune system (immune-suppression) in the last year and have mild or moderate symptoms caused by COVID-19. Lopinavir/ritonavir may help to lessen or prevent COVID-19 symptoms from getting worse in cancer patients.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine if treatment with lopinavir/ritonavir will decrease progression of symptoms compared to control/placebo.

SECONDARY OBJECTIVES:

  1. Determine if treatment improves time to symptom resolution. II. Determine the time to symptom progression. III. Determine time to improvement of participants as defined by complete resolution of symptoms.

IV. Determine the proportion of participants who have severe or critical symptoms and hospital admission.

  1. Determine the time to hospital admission for those who develop severe of critical symptoms VI. Determine the proportion of participants with an intensive care unit (ICU) admission.

VII. Determine the proportion of participants receiving ventilator support. VIII. Determine survival of participants enrolled on the study.

EXPLORATORY OBJECTIVES:

  1. For patients admitted to the hospital, will determine the following parameters: potassium level, blood oxygen level, creatinine, and blood pressure.

II. Identify obstacles and barriers encountered while implementing a clinical trial in the context of a pandemic caused by a contagious disease and associated social distancing.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive lopinavir/ritonavir orally (PO) twice daily (BID) for 14 days in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive placebo PO BID for 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up 3 times a week until symptoms resolve plus 2 additional weeks thereafter, for up to 3 months, whichever occurs first.

Being tested
Lopinavir/Ritonavir, Placebo Administration, Questionnaire Administration
Medical subject headings
Hematologic Neoplasms

What participants receive

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

  • Lopinavir/RitonavirDrug

    Also called Kaletra

    Given PO

  • Placebo AdministrationDrug

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04455958
Study groupRoleWhat they receive
Group I (lopinavir/ritonavir)ExperimentalPatients receive lopinavir/ritonavir PO BID for 14 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Lopinavir/Ritonavir; Other: Questionnaire Administration
Group II (placebo)Placebo comparatorPatients receive placebo PO BID for 14 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Placebo Administration; Other: Questionnaire Administration

What is being measured

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

  1. Severity of symptoms

    Will be compared to the time of randomization. The severity of symptoms will be categorized as mild, moderate, severe, or critical according to the grading of symptoms. The proportion of participants with progression to more severe symptoms between treatments groups will be compared using a Fisher's Exact test at a 0.05 significance level.

    Measured: 3 months

Secondary outcomes (7)

  1. Clinical benefit rate of lopinavir/ritonavir

    Will be defined as improvement on symptoms: yes or no. Will be compared between treatment groups using log-rank test. A 95% confidence interval of treatment rate difference in symptom progression will be calculated by the Wald method.

    Measured: 3 months

  2. Time to symptom progression

    Will be compared between treatment groups using log-rank test.

    Measured: From randomization to the first documented symptoms progression, assessed up to 3 months

  3. Time to improvement of participants

    Will be compared between treatment groups using log-rank test.

    Measured: From randomization to first documented complete resolution of symptoms, assessed up to 3 months

  4. Time to hospital admission for those who develop severe of critical symptoms

    Will be compared between treatment groups using log-rank test.

    Measured: From time of randomization to the time of hospital admission, assessed up to 3 months

  5. Intensive care unit (ICU) admission: yes or no

    Will be compared using Fisher's exact test, and point and interval estimates will be provided.

    Measured: 3 months

  6. Receiving ventilator support: yes or no

    Will be compared using Fisher's exact test, and point and interval estimates will be provided.

    Measured: 3 months

  7. Overall survival

    Will be compared using Fisher's exact test, and point and interval estimates will be provided.

    Measured: From randomization to death due to any cause, assessed up to 3 months

Timeline

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

  1. First posted2 Jul 2020
  2. Study start1 May 2021 (estimated)
  3. Primary completion1 Nov 2021 (estimated)
  4. Study completion1 Nov 2021 (estimated)

Why it stopped: limited resources

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04455958
Sponsor's protocol ID
STUDY00021444
Other IDs
NCI-2020-02877, STUDY00021444
Status last verified
Apr 2021
First submitted
1 Jul 2020
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lopinavir/Ritonavir and Questionnaire Administration in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute.

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 18 inclusion and 10 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: withdrawn, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Severity of symptoms (time frame: 3 months). 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 NCT04455958.

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 26 Apr 2021.

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