COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04542993

Chris Nunn, MD

CancerResearch@swedish.org

2020-09-09

Terminated

RCT

Randomized

Single group assignment

Blind label

single-center

Treatment

inclusion criteria: adults (18 - 75) with a nasal swab confirmed sars-cov-2 infection; testing positive within 4 days of enrollment ability to read, understand and provide informed consent (no legally authorized representatives may consent on their behalf) and study assessments in english ability for subject to comply with the requirements of the study (must/will have a valid email address, internet connection and phone number) willingness to self limit medications and supplements and report what they are taking comfortable self-administering oral medication and nasal swab sampling willingness to permit a review of their medical history and to provide medical data from their electronic medical record for the period of enrollment (14 days) and until resolution of covid-19 related events. individuals who are not current swedish patients will be asked to identify their provider of record and provide access to specific elements of their electronic health record. reside within twenty-five miles of one of the swedish campuses: first hill, ballard, edmonds, issaquah, cherry hill.

reported history or evidence of impaired liver or kidney function: gfr <30 or bilirubin >2x ult or inr > 2x ult in the absence of anticoagulants known hypersensitivity to zinc or resveratrol diagnosis of covid-19 or sars-cov-2 infection >4 days before enrollment preexisting severe pulmonary disease requiring supplemental oxygen clinically evident impairment of cognitive function, per physician discretion active substance abuse that may prevent the subject from completing the protocol requirements, per physician discretion. active psychotic or affective disorder that may prevent the subject from completing the protocol requirements, per physician discretion. pregnant or lactating females. coumadin treatment that can not be halted during the study period

2

Swedish Medical Center

18

75

United States

Mild disease at enrollment

1: Mild disease at enrollment

45

Reduction in SARS-CoV-2 Viral load;Reduction in Severity of COVID-19 Disease

None

Phase 2

[{"arm_notes": "", "treatment_id": 2264, "treatment_name": "Resveratrol+zinc", "treatment_type": "Nutrition+vitamins and dietary supplements", "pharmacological_treatment": "Non pharmacological treatment+pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]