Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT04455958
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.
Study:
NCT04455958
Study Brief:
Protocol Section:
NCT04455958