COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04798677

Julián A. Mateus Rodríguez

Not reported

2021-03-15

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: common criteria: - subjects with the ability to take the study product orally - ability to understand the study, the information about the symptoms and to comply with the treatment shots. - subject or legal guardian / representative willing to give informed consent in writing. influenza vaccine groups: - subjects who require hospitalization or external follow-up (outpatients or pades) - subjects over 60 years old who will receive the influenza vaccine covid-19 vaccine groups - subjects from long-stay centres attached to the hospital mare de déu de la mercè, and meet the following inclusion criteria: - groups: - subjects over 18 years of age who receive the covid-19 vaccine, in a stable clinical situation, at the discretion of the researcher, or - healthcare workers of the study centers, over 18 years of age who receive the covid-19 vaccine - availability to attend clinical visits.

common criteria: - need for assisted ventilation that makes oral consumption of the product under study impossible - history of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients. - history or evidence of any medical conditions or medication use that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations - subjects in situation of last days covid-19 vaccine groups: - subjects in whom the covid-19 vaccine is contraindicated. - a history of frailty or comorbidity that indicates a situation of clinical instability. - history or evidence of any medical conditions or drug use that, in the opinion of the principal investigator, could affect the safety of subjects or interfere with study evaluations.

2

AB Biotek

18

100

Spain

Healthy volunteers

N/A

72

Change in blood levels of selenium and zinc;Change in the acute immune response to the Covid-19 vaccine after supplementation (Covid-19 vaccine groups);Change in the acute immune response to the influenza vaccine after supplementation (influenza vaccine groups);Change in the delayed immune response to the Covid-19 vaccine after supplementation (Covid-19 vaccine groups);Change in the delayed immune response to the influenza vaccine after supplementation (influenza vaccine groups)

None

Not reported

[{"arm_notes": "", "treatment_id": 7, "treatment_name": "Abbc1", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]