COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04276688

Ivan FN Hung, MD FRCP

Not reported

2020-02-19

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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.

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.

2

The University of Hong Kong

18

None

Hong Kong

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

127

Time to negative NPS

None

Phase 2

[{"arm_notes": "", "treatment_id": 2209, "treatment_name": "Interferon beta 1+lopinavir+ribavirin+ritonavir", "treatment_type": "Interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]