COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04350281

Ivan FN Hung

ivanhung@hku.hk

2020-04-17

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: recruited subjects include all adult patients ≥18 years hospitalized for virologic confirmed sars-cov-2 infection. all subjects give written informed consent. for patients who are critically ill, requiring icu, ventilation or confused, informed consent will be obtained from spouse, next-of-kin or legal guardians. 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 qtc syndrome, ventricular cardiac arrhythmias, including torsade de pointes, second or third degree heart block, qtc interval >480ms patients taking medication that will potentially interact with l interferon beta-1b or hydroxychloroquine patients with known underlying retinopathy patients with g6pd deficiency patients with known history of severe depression 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. to participate in an unrelated trial during the current clinical trial. nevertheless, the patients have the right to withdraw from the current clinical trial to join another clinical trial. 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

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

60

Time to negative NPS viral load

None

Phase 2

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1558, "treatment_name": "Hydroxychloroquine+interferon beta 1b", "treatment_type": "Antimalarials+interferons", "pharmacological_treatment": "Pharmacological treatment"}]