Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT04455958
Status:
WITHDRAWN
Last Update Posted:
2021-04-26
First Post:
2020-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lopinavir/Ritonavir for the Treatment of COVID-19 Positive Patients With Cancer and Immune Suppression in the Last Year
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
limited resources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. Lopinavir/ritonavir may help to lessen or prevent COVID-19 symptoms from getting worse in cancer patients.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine if treatment with lopinavir/ritonavir will decrease progression of symptoms compared to control/placebo.
SECONDARY OBJECTIVES:
I. 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.
V. 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:
I. 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.
I. To determine if treatment with lopinavir/ritonavir will decrease progression of symptoms compared to control/placebo.
SECONDARY OBJECTIVES:
I. 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.
V. 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:
I. 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: