COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04551339

Atta Behfar, MD, PhD

Not reported

2020-09-16

Completed

RCT

Randomized

Parallel

Open label

multi-center

Prevention

inclusion criteria: - age ≥50 years old or primary healthcare professional (defined as having a job that has had direct patient contact during the covid-19 pandemic) and ≥18 years old - no symptoms of covid-19 (a fever of 100.0o f or greater, or a new cough, or new shortness of breath, or new sore throat, or new diarrhea, or new fast breathing (respiratory distress), or new chills, or new muscle aches (myalgias), or new loss of smell, or new change or loss of taste sensation) in the past 7 days - have a negative elecsys anti-sars-cov-2 immunoassay antibody test at screening - have not had close contact with a person with a laboratory confirmed case of covid-19 without full ppe (close contact is defined by cdc as: being within approximately 6 feet of a covid-19 patient for a total of 15 minutes or more over a 24 hour period) or having direct contact with infectious secretions of a covid-19 patient (e.g. being coughed on)) in the last 14 days - mayo clinic patient who has a patient online account set up or is willing to set up an online account - must have a valid email address and internet service

history of positive or indeterminate covid pcr test prior to screening or elecsys anti-sars-cov-2 immunoassay antibody test positive or indeterminate at screening active symptoms of covid ((a fever of 100.0o f or greater, or a new cough, or new shortness of breath, or new sore throat, or new diarrhea, or new fast breathing (respiratory distress), or new chills, or new muscle aches (myalgias), or new loss of smell, or new change or loss of taste sensation)) in past 7 days known intolerance to multivitamins or zinc supplements from prior exposure inability to complete follow-up questions or grant access to electronic health record for surveillance have had close contact with a person with a laboratory confirmed case of covid-19 in past 14 days current or former smoker less than 5 years ago pregnant or breastfeeding prisoner any subject with known immunosuppressed state, including a history of solid organ or bone marrow transplantation subjects currently receiving chemotherapy current rheumatologic or autoimmune illness requiring treatment with glucocorticoids, antimetabolite agents (methotrexate, azathioprine, mercaptopurine, fluorouracil, mycophenolate, leflunomide), imids (lenalidomide, thalidomide, pomalidomide), calcineurin inhibitors (tacrolimus, cyclosporine), mtor inhibitors (sirolimus, everolimus), or any monoclonal antibody drugs (including any drug given intravenously or subcutaneously) for the purpose of immunosuppression subjects with hiv or primary immunodeficiency syndromes

2

Mayo Clinic

18

90

United States

Health workers

N/A

2700

COVID-19 illness requiring hospitalization

None

Not reported

[{"arm_notes": "", "treatment_id": 264, "treatment_name": "Centrum adult (under 50) multivitamin", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2265, "treatment_name": "Beta-carotene+copper+vitamin c+vitamin e+zinc", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}]