Novel Coronavirus Infection Clinical Trial
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
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
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
Subject/patient 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
400mg/100mg twice daily, ribavirin 400mg bd and zero to three doses of subcutaneous injection
of interferon beta-1b 1mL (0.25mg; 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
400mg/100mg twice daily plus standard care alone (2:1).
Intervention/study 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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04610515 -
Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)
|