COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-8ykm72j

Roberto Badaró

badaro@fieb.org.br

2021-04-08

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

Cohort 1, males and females between 55 years and 85 years of age, history of close contact (cohabit) with a family member or a person newly diagnosed with SARS-CoV-2 infection, negative RT-PCR COVID-19 test on the screening and prior to start treatment . Cohort 2, males and females between 18 years and 85 years of age,confirmed virology diagnostic of COVID-19, asymptomatic ou mild COVID 19 pneumonia.

Females of childbearing potential who are pregnant, lactating, or who have not adhered to an adequate contraception method from at least 30 days prior to study entry and who do not plan to do so for at least 1 month post last supplementation,Patients that are doing hormonal replacement therapy, severe COVID-19 pneumonia according to CDC criteria associated with CT Severe Illness Critical Illness: Individuals who have respiratory failure, septic shock, and/or multiple organ, positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies, known or suspected alcohol or drug abuse within the past 6 months prior to screening,participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to screening,treatment with immunosuppressive cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to screening,patients unable to sign the inform consent to participate into the study, History of any other acute or uncontrolled chronic illness (including, hypertension, cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders) that is not on medication regimen for at least the past 6 months, or use of medication or supplements that, in the opinion of the Principal Investigator, may interfere with the evaluation of the safety and tolerability of the study drug such as ACE Inhibitors, Angiotensin II Receptor Blockers (ARBs)

4

Lonza Consumer Health Inc.

18

85

Brazil

Mild disease at enrollment

1: Mild disease at enrollment

0

In Cohort 1: incidence of new SARS-CoV-2 cases in the group of LCT recipients versus placebo recipients in family or close friend/contact/cohabitant contacts of index COVID-19 case;In Cohort 2: differences in the number of cases that progress from asymptomatic or milddisease to severe COVID-19 pneumonia of patients using LCT versus the placebo group.

Phase 2

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