Pneumonia, COVID - 19
Conditions
Interventions
Cohort 1: 220 Healthy subjects, of 55 to 85 years of age, with and close contact (cohabit) with a person or a cluster of persons with newly SARS-CoV-2 infection, and currently SARS-CoV-2 negative by P
G07.203.300.456
Sponsors
Lonza Consumer Health Inc.
SENAI CIMATEC
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 mild disease to severe COVID-19 pneumonia of patients using LCT versus the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the levels of C-Reactive Protein (CRP) with CRP levels at the enrolment in the study and in Days 3, 7, 14 and 21 days after start the administration comparing the administration of LCT group with the placebo group in each cohort;Cohort 2: Evaluate differences in the number of cases that progress from asymptomatic or mild disease to severe COVID-19 pneumonia of patients using LCT versus the placebo group assessed by chest tomography;Cohort 1: To evaluate the disease severity and progression in the subjects who become COVID-19 positive by analyzing laboratory parameters after the disease onset;To compare the levels of plasma ACE1 and ACE2 receptors between the two groups of studied patients (LCT group versus placebo group) at baseline and every seven days until the end of the study of each cohort;To compare the ACE1/ACE2 ratio between the two groups of studied patients in cohort 1 and 2 (LCT group versus placebo group) at baseline and every seven days until the end of the study of each cohort;To evaluate ACE1, ACE2, TMPRSS2 and furin gene expression levels at the entry into the study and 21 days after the administration of supplement or placebo in each cohort;Cohort 2: To compare progression of the lung chest CT scan images between the two groups of patients (LCT group of patients versus placebo group) on the days of entry into the study and days 7, 14 and 21 for the progression of the presence of ground-glass opacity, consolidation, parenchymal bands, and crazy-paving pattern of = 25% lesions to = 40%. A semi-quantitative CT scoring system will be used for estimating lung abnormalities of each lobe;;To compare the serum levels of inflammatory cytokines IL-6, IL-2, IL-7, IL-10, granulocyte-colony stimulating factor (GM-CSF), interferon-? (IFN-?) and Tumor Necrosis Factor (TNF-a) on days 3, 7, 14 and 21 after the administration of LCT on supplement or placebo supplement. Difference of > 50% in the reduction on the levels at day 21 in com | — |
Countries
Brazil
Outcome results
None listed