Ignite Creation Date:
2024-05-06 @ 2:18 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04276688
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2020-02-11
Brief Title:
Lopinavir Ritonavir Ribavirin and IFN-beta Combination for nCoV Treatment
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
An Open-label Randomized Controlled Trial on Lopinavir Ritonavir Ribavirin and Interferon Beta 1b Combination Versus Lopinavir Ritonavir Alone as Treatment for 2019 Novel Coronavirus Infection
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A combination of lopinavir ritonavir ribavirin and interferon beta-1b will expedite the recovery suppress the viral load shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir ritonavir
Detailed Description:
Hypothesis A combination of lopinavir ritonavir ribavirin and interferon beta-1b will expedite the recovery suppress the viral load shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir ritonavir alone
Primary objective To evaluate the safety and efficacy in mortality reduction with a combination of lopinavir ritonavir ribavirin and interferon beta-1b in the treatment of patient hospitalised for 2019-n-CoV infection and compare this to lopinavir ritonavir alone
Subjectpatient definition Recruited subjects include adult patients 18 years of age admitted to the HA Hospitals from February 2020 onwards with laboratory confirmed 2019-n-CoV infection All subjects give written informed consent Subjects must be available to complete the study and comply with study procedures
Study design This is a prospective open-label randomised controlled trial among adult patients hospitalised after February 2020 for virologically confirmed 2019-n-CoV infection Patients will be randomly assigned to either a 14-day course of lopinavir ritonavir 400mg100mg twice daily ribavirin 400mg bd and zero to three doses of subcutaneous injection of interferon beta-1b 1mL 025mg 8 million IU on day 1 3 and 5 depending on day of admission from symptoms onset plus standard care or a 14-day course of lopinavir ritonavir 400mg100mg twice daily plus standard care alone 21
Interventionstudy article lopinavir ritonavir ribavirin and interferon beta-1b
Primary outcome Time to negative nasopharyngeal swab NPS 2019-n-CoV coronavirus viral RT-PCR
Secondary outcome
1 Time to negative saliva 2019-n-CoV coronavirus viral RT-PCR
2 Time to clinical improvement of NEWS2 National Early Warning Score 2 of 0 maintained for 24 hours
3 Length of hospitalisation
4 Adverse events during treatment
5 30-day mortality
6 Cytokine chemokine changes
Primary objective To evaluate the safety and efficacy in mortality reduction with a combination of lopinavir ritonavir ribavirin and interferon beta-1b in the treatment of patient hospitalised for 2019-n-CoV infection and compare this to lopinavir ritonavir alone
Subjectpatient definition Recruited subjects include adult patients 18 years of age admitted to the HA Hospitals from February 2020 onwards with laboratory confirmed 2019-n-CoV infection All subjects give written informed consent Subjects must be available to complete the study and comply with study procedures
Study design This is a prospective open-label randomised controlled trial among adult patients hospitalised after February 2020 for virologically confirmed 2019-n-CoV infection Patients will be randomly assigned to either a 14-day course of lopinavir ritonavir 400mg100mg twice daily ribavirin 400mg bd and zero to three doses of subcutaneous injection of interferon beta-1b 1mL 025mg 8 million IU on day 1 3 and 5 depending on day of admission from symptoms onset plus standard care or a 14-day course of lopinavir ritonavir 400mg100mg twice daily plus standard care alone 21
Interventionstudy article lopinavir ritonavir ribavirin and interferon beta-1b
Primary outcome Time to negative nasopharyngeal swab NPS 2019-n-CoV coronavirus viral RT-PCR
Secondary outcome
1 Time to negative saliva 2019-n-CoV coronavirus viral RT-PCR
2 Time to clinical improvement of NEWS2 National Early Warning Score 2 of 0 maintained for 24 hours
3 Length of hospitalisation
4 Adverse events during treatment
5 30-day mortality
6 Cytokine chemokine changes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None