COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04647695

Ivan FN Hung, MD FRCP

ivanhung@hku.hk

2020-12-01

Unknown

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. fulfilling one of the following criteria associated with high risk of clinical deterioration: age 65 years or above, radiological evidence of pneumonia, oxygen desaturation <94% on room air, comorbidity including hypertension, diabetes, cardiovascular diseases, chronic obstructive lung disease, chronic liver diseases, chronic kidney diseases, malignancy, haematological diseases, rheumatological diseases, immunocompromised hosts and obesity (bmi > 30) 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 taking medication that will potentially interact with l interferon beta-1b and remdesivir patients with known history of severe depression estimated glomerular filtration rate <30 ml/min 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

100

Hong Kong

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

100

Clinical improvement

None

Phase 2

[{"arm_notes": "", "treatment_id": 1591, "treatment_name": "Interferon beta 1b+remdesivir", "treatment_type": "Interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]