COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04552379

Jose A Castro Rodriguez, MD, PhD

jacastro17@hotmail.com

2020-09-17

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: index cases: provided a signed and dated informed consent form aged 18 to <80 years of age confirmed sars-cov-2 diagnosis by pcr within 72 hours of first treatment dose the first known diagnosis in the household not currently enrolled in a clinical trial and agree to not take any other investigational treatments over the next 28 days must plan to remain resident in the household during the study lives in household with at least one other 'treatment-eligible household contact' treatment-eligible household contacts: provided a signed and dated informed consent form aged 18 to <80 years of age, not currently enrolled in a clinical trial and agree to not take any other investigational treatments over the next 28 days must plan to remain resident in the household during the study no history of previously confirmed sars-cov-2 diagnosis treatment-ineligible household contacts: provided a signed and dated informed consent form, parental informed consent, and assent if applicable under 18 years or ≥ 80 years of age or aged 18 to <80 years with any contraindication for ifn treatment listed in 'exclusion criteria' not currently enrolled in a clinical trial and agree to not take any other investigational treatments over the next 28 days must plan to remain resident in the household during the study no history of previously confirmed sars-cov-2 diagnosis

index cases and treatment-eligible household contacts: inability to take medications orally or injected known sensitivity/allergy to interferons or use of interferons for another indication known adverse drug-drug interactions with any study drugs malignancy known clinical immune deficiency pregnancy or unwillingness, of female participants of childbearing potential to use recognised methods of birth control/contraception during the trial period, retinopathy, known grade 4 or 5 chronic kidney or liver disease, known arrhythmias, known autoimmune diseases or chronic inflammatory disease, chronic liver disease, hospitalisation for depression in the last 3 months, current suicidal ideation, previous therapeutic use of ifn all subjects: declined participation, the index case has been in complete self-quarantine from other household members during the 48 hours prior to diagnosis of sars-cov-2 infection.

4

Pontificia Universidad Catolica de Chile

18

79

Chile

No restriction on type of patients

0: No restriction on type of patients

1173

The proportion of household contacts shedding SARS-CoV-2, at Day 11, in the active arm compared to the standard of care arm.;The proportion of index cases shedding SARS-CoV-2, at Day 11, in the active arm compared to the standard of care arm.

None

Phase 3

[{"arm_notes": "", "treatment_id": 965, "treatment_name": "Peginterferon beta-1a", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 965, "treatment_name": "Peginterferon beta-1a", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]