Lopinavir/ Ritonavir, Ribavirin and IFN-beta Combination for nCoV Treatment
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| ClinicalTrials.gov Identifier: NCT04276688 |
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Recruitment Status :
Completed
First Posted : February 19, 2020
Last Update Posted : April 15, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Novel Coronavirus Infection | Drug: Lopinavir/ritonavir Drug: Ribavirin Drug: Interferon Beta-1B | Phase 2 |
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:
- Time to negative saliva 2019-n-CoV coronavirus viral RT-PCR
- Time to clinical improvement of NEWS2 (National Early Warning Score 2) of 0 maintained for 24 hours
- Length of hospitalisation
- Adverse events during treatment
- 30-day mortality
- Cytokine/ chemokine changes
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 127 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | open-label randomised controlled trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 10, 2020 |
| Actual Primary Completion Date : | March 30, 2020 |
| Actual Study Completion Date : | March 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Study group
triple combination
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Drug: Lopinavir/ritonavir
400mg/100mg twice daily for 14 days Drug: Ribavirin 400mg twice daily for 14 days Drug: Interferon Beta-1B 0.25mg subcutaneous injection alternate day for 3 days |
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Active Comparator: Control group
single
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Drug: Lopinavir/ritonavir
400mg/100mg twice daily for 14 days |
- Time to negative NPS [ Time Frame: Up to 1 month ]Time to negative NPS 2019-n-CoV RT-PCR
- Time to negative saliva [ Time Frame: Up to 1 month ]Time to negative saliva 2019-n-CoV RT-PCR
- Time to clinical improvement [ Time Frame: Up to 1 month ]Time to NEWS of 0
- Hospitalisation [ Time Frame: Up to 1 month ]Length of hospitalisation
- Mortality [ Time Frame: Up to 1 month ]30-day mortality
- Immune reaction [ Time Frame: up to 1 month ]Cytokine/ chemokine changes
- Adverse events [ Time Frame: up to 1 month ]Adverse events during treatment
- Time to negative all clinical specimens [ Time Frame: up to 1 month ]Time to negative NPS, saliva, urine and stool 2019-n-CoV RT-PCR
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Recruited subjects include all adult patients ≥18 years hospitalised for virologically confirmed 2019-n-CoV infection.
- NEWS of ≥1 upon recruitment
- Auditory temperature ≥38°C with at least one of the following symptoms (cough, sputum production, sore-throat, nasal discharge, myalgia, headache or fatigue) upon admission
- Symptom duration ≤10 days
- All subjects give written informed consent.
- Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Exclusion Criteria:
- Inability to comprehend and to follow all required study procedures.
- Allergy or severe reactions to the study drugs
- Patients with known prolonged QT or PR interval, second- or third-degree heart block, or ventricular cardiac arrhythmias, including torsade de pointes
- Patients taking medication that will potentially interact with lopinavir/ ritonavir, ribavirin or interferon-beta1b
- Patients with known history of severe depression
- Pregnant or lactation women
- Inability to comprehend and to follow all required study procedures
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to recruitment in this study or expect to receive an experimental agent during this study. Unwilling to refuse participation in another clinical study through the end of this study.
- Have a history of alcohol or drug abuse in the last 5 years.
- Have any condition that the investigator believes may interfere with successful completion of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276688
| Hong Kong | |
| University of Hong Kong, Queen Mary Hospital | |
| Hong Kong, Hong Kong | |
| Principal Investigator: | Ivan FN Hung, MD FRCP | The University of Hong Kong |
| Responsible Party: | The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT04276688 |
| Other Study ID Numbers: |
UW-20-074 |
| First Posted: | February 19, 2020 Key Record Dates |
| Last Update Posted: | April 15, 2020 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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nCoV lopinavir/ ritonavir IFN-beta |
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Infection Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Interferons Ritonavir Ribavirin Lopinavir Interferon-beta Interferon beta-1b |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antimetabolites Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |