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Clinical Study to Evaluate the Effect of Food Supplement in People Infected With Coronavirus

Primary Purpose

COVID-19 Virus Infection

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
LCLT : 68% elemental L-carnitine and 32 % Tartric acid
Placebo
Sponsored by
SENAI CIMATEC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Virus Infection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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 immediately after contact and prior to start treatment of the study.

  2. Cohort 2:

    • males and females between 18 years and 85 years of age;
    • positive RT-PCR COVID-19 test and medical history and physical exam compatible with asymptomatic or mild COVID-19 pneumonia. Evaluation of clinical outcomes: oxygen requirements, hospitalization breathless and others;

    • Female subjects of childbearing potential must :

      • have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study supplementation;
      • no breast-feeding;
      • agree to use one of the following methods of contraception from enrollment in study until 30 days after last supplementation (only if in sexual relationships with men): hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); or abstinence; bilateral tubal ligation (if no conception post-procedure); tubal occlusion; or bilateral salpingectomy. Women are considered non-child-bearing potential if they are post-menopausal (defined as at least 12 months spontaneous amenorrhea and confirmed with FSH > 40 mIU/ml) or have had documented hysterectomy and/or oophorectomy. system (IUS); vasectomized partner (6 months minimum); or abstinence; bilateral tubal ligation (if no conception post-procedure); tubal occlusion; or bilateral salpingectomy;
    • Normal laboratory values of sodium, potassium, ALT, AST, total bilirubin, alcaline phosphatase, creatinine, fasting glucose, total WBC count, hemoglobina and platelet count;
    • No medical history of alcohol or drug abuse

Exclusion Criteria:

  • Hormonal replacement therapy;
  • Severe COVID-19 pneumonia according to CDC criteria;
  • Positive test for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies;
  • Participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to Screening;
  • Immunosuppressive cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to Screening;
  • Subjects 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;
  • Medication or supplements that may interfere with the evaluation of the safety and tolerability of the study drug such as ACE Inhibitors, Angiotensin II Receptor Blockers (ARBs) (e.g. vitamin B3 and L-carnitine/acetyl-carnitine).

Sites / Locations

  • Senai Cimatec

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

covid 19 LCLT supplement

covid 19 placebo

Healthy LCLT supplement

Healthy Placebo

Arm Description

LCLT is made out of 68% elemental L-carnitine and 32 % Tartric acid and therefore the EFSA (European Food Safety Authority) stated that it is safety up to at least 3 g. Each 3 g of LCLT delivers 2 g of elemental L-carnitine L-carnitine and Tartric acid, 3g oral capsules daily use for 21 days

The formulation will contain all salt ingredients v/v without LCLT (made out of 68% elemental L-carnitine and 32 % Tartric acid) and is replaced by Maltodextrin in the placebo capsules Placebo capsules daily for 21 days

LCLT is made out of 68% elemental L-carnitine and 32 % Tartric acid and therefore the EFSA (European Food Safety Authority) stated that it is safety up to at least 3 g. Each 3 g of LCLT delivers 2 g of elemental L-carnitine L-carnitine and Tartric acid, 3g oral capsules daily use for 21 days

The formulation will contain all salt ingredients v/v without LCLT (made out of 68% elemental L-carnitine and 32 % Tartric acid) and is replaced by Maltodextrin in the placebo capsules Placebo capsules daily for 21 days

Outcomes

Primary Outcome Measures

Number new SARS-CoV-2 cases at 21 days assessed by RT-PCR
Number new SARS-CoV-2 cases at 21 days assessed by RT-PCR
Number of participants with severe COVID pneumonia measured by the presence of ground-glass opacity, consolidations, parenchymal bands, and crazy-paving pattern in chest tomography
Number of participants with severe COVID pneumonia measured by the presence of ground-glass opacity, consolidations, parenchymal bands, and crazy-paving pattern in chest tomography

Secondary Outcome Measures

Levels of C-Reactive Protein (CRP) from baseline to 7, 14 and 21 days
Levels of C-Reactive Protein (CRP) from baseline to 7, 14 and 21 days
Total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days
Total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days
Levels of plasma ACE1 and ACE2 receptors from baseline to 7, 14 and 21 days
Levels of plasma ACE1 and ACE2 receptors from baseline to 7, 14 and 21 days
ACE1/ACE2 ratio from baseline to 7, 14 and 21 days days until the end of the study of each cohort
ACE1/ACE2 ratio from baseline to 7, 14 and 21 days days until the end of the study of each cohort
ACE1, ACE2, TMPRSS2 and furin gene expression levels from baseline to 21 days placebo in each cohort
ACE1, ACE2, TMPRSS2 and furin gene expression levels from baseline to 21 days
Presence of presence of ground-glass opacity, consolidations, parenchymal bands, and crazy-paving pattern in chest tomography from baseline to 7, 14 and 21 days
Presence of presence of ground-glass opacity, consolidations, parenchymal bands, and crazy-paving pattern in chest tomography from baseline to 7, 14 and 21 days
Levels of inflammatory cytokines IL-6, IL-2, IL-7, IL-10,granulocyte-colony stimulating factor (GM-CSF), interferon-γ (IFN-γ) and Tumor Necrosis Factor (TNF-α) from baseline to 7, 14 and 21 days
Levels of inflammatory cytokines IL-6, IL-2, IL-7, IL-10,granulocyte-colony stimulating factor (GM-CSF), interferon-γ (IFN-γ) and Tumor Necrosis Factor (TNF-α) from baseline to 7, 14 and 21 days
Levels of total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort
Levels of total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days
Levels of hemoglobin count (g/dl) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort
Levels of hemoglobin count (g/dl) from baseline to 7, 14 and 21 days
Total platelets count (1000 per mm³) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort
Total platelets count (1000 per mm³) from baseline to 7, 14 and 21 days
Levels of fibrinogen (g/L) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in
Levels of fibrinogen (g/L) from baseline to 7, 14 and 21 days
Levels of D-Dimer (µg/mL) from baseline to 7, 14 and 21 days
Levels of D-Dimer (µg/mL) from baseline to 7, 14 and 21 days
Levels of Ferritin (µg/mL) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort
Levels of Ferritin (µg/mL) from baseline to 7, 14 and 21 days

Full Information

First Posted
April 23, 2022
Last Updated
June 30, 2022
Sponsor
SENAI CIMATEC
Collaborators
Hospital Espanhol
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1. Study Identification

Unique Protocol Identification Number
NCT05446961
Brief Title
Clinical Study to Evaluate the Effect of Food Supplement in People Infected With Coronavirus
Official Title
Pilot Phase II Randomized, Placebo-Controlled Clinical Trial for the Prevention and Progression of SARS-CoV-2 Infection of Subjects and Patients Using a Supplement Treatment With Carnipure Tartrate ( LCLT)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
February 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SENAI CIMATEC
Collaborators
Hospital Espanhol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to assess safety and efficacy of Carnipure tartrate (L-Carnitine and L-tartaric acid - LCLT) supplementation for SARS-Cov-2 infection
Detailed Description
After being informed about the study and potential risks, all patients given written informed consent will be divided em two cohorts according to inclusion criteria.One group with patients with diagnosed mild SARS-Cov-2 infection and another with healthy contacts of patients with diagnosed mild SARS-Cov-2. Both groups will be randomized to receive either LCLT supplementation or placebo during 21 days. After this period primary endpoints of efficacy will be assessed. Clinical follow up evaluations will be monitored (Cohort 1 and 2), and chest tomography will be monitored in cohort 2 as well. Subjects will be followed for safety through 8 weeks (cohort 1) and 6 weeks (cohort 2) after being included into the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Model Description
A total of 274 subjects, will be prospectively enrolled into a pilot randomized, placebo controlled study in the two cohorts: Cohort 1: 220 healthy, SARS-CoV-2 negative, individuals (55 to 85 years old) with close contact (cohabit) to a person with newly acquired SARS-CoV-2 infection based on PCR detection and absence of antibody response; and, Cohort 2: 54 asymptomatic ( 18 to 85 years old) or symptomatic patients with mild COVID-19 that tested positive for COVID-19 by RT-PCR within the last 24 hours prior to the enrolment in the study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The groups will be randomized and blindly assigned to receive either the LCLT supplement (3 g per day that delivers 2 g elemental of L-carnitine) or placebo. Subjects from Cohort 2 will receive L-carnitine in addition to Standard of Care (SOC) therapy or placebo in addition tosStandard of care (SOC) therapy
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
covid 19 LCLT supplement
Arm Type
Active Comparator
Arm Description
LCLT is made out of 68% elemental L-carnitine and 32 % Tartric acid and therefore the EFSA (European Food Safety Authority) stated that it is safety up to at least 3 g. Each 3 g of LCLT delivers 2 g of elemental L-carnitine L-carnitine and Tartric acid, 3g oral capsules daily use for 21 days
Arm Title
covid 19 placebo
Arm Type
Placebo Comparator
Arm Description
The formulation will contain all salt ingredients v/v without LCLT (made out of 68% elemental L-carnitine and 32 % Tartric acid) and is replaced by Maltodextrin in the placebo capsules Placebo capsules daily for 21 days
Arm Title
Healthy LCLT supplement
Arm Type
Active Comparator
Arm Description
LCLT is made out of 68% elemental L-carnitine and 32 % Tartric acid and therefore the EFSA (European Food Safety Authority) stated that it is safety up to at least 3 g. Each 3 g of LCLT delivers 2 g of elemental L-carnitine L-carnitine and Tartric acid, 3g oral capsules daily use for 21 days
Arm Title
Healthy Placebo
Arm Type
Placebo Comparator
Arm Description
The formulation will contain all salt ingredients v/v without LCLT (made out of 68% elemental L-carnitine and 32 % Tartric acid) and is replaced by Maltodextrin in the placebo capsules Placebo capsules daily for 21 days
Intervention Type
Dietary Supplement
Intervention Name(s)
LCLT : 68% elemental L-carnitine and 32 % Tartric acid
Other Intervention Name(s)
Carnipure™ Tartrate (LCLT) formulation
Intervention Description
3 g orally capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
orally capsules
Primary Outcome Measure Information:
Title
Number new SARS-CoV-2 cases at 21 days assessed by RT-PCR
Description
Number new SARS-CoV-2 cases at 21 days assessed by RT-PCR
Time Frame
21 days
Title
Number of participants with severe COVID pneumonia measured by the presence of ground-glass opacity, consolidations, parenchymal bands, and crazy-paving pattern in chest tomography
Description
Number of participants with severe COVID pneumonia measured by the presence of ground-glass opacity, consolidations, parenchymal bands, and crazy-paving pattern in chest tomography
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Levels of C-Reactive Protein (CRP) from baseline to 7, 14 and 21 days
Description
Levels of C-Reactive Protein (CRP) from baseline to 7, 14 and 21 days
Time Frame
1,7,14 and 21 days
Title
Total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days
Description
Total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days
Time Frame
1,7,14 and 21 days
Title
Levels of plasma ACE1 and ACE2 receptors from baseline to 7, 14 and 21 days
Description
Levels of plasma ACE1 and ACE2 receptors from baseline to 7, 14 and 21 days
Time Frame
1, 7, 14 and 21 days
Title
ACE1/ACE2 ratio from baseline to 7, 14 and 21 days days until the end of the study of each cohort
Description
ACE1/ACE2 ratio from baseline to 7, 14 and 21 days days until the end of the study of each cohort
Time Frame
1, 7, 14 and 21 days
Title
ACE1, ACE2, TMPRSS2 and furin gene expression levels from baseline to 21 days placebo in each cohort
Description
ACE1, ACE2, TMPRSS2 and furin gene expression levels from baseline to 21 days
Time Frame
1 and 21 days
Title
Presence of presence of ground-glass opacity, consolidations, parenchymal bands, and crazy-paving pattern in chest tomography from baseline to 7, 14 and 21 days
Description
Presence of presence of ground-glass opacity, consolidations, parenchymal bands, and crazy-paving pattern in chest tomography from baseline to 7, 14 and 21 days
Time Frame
1, 7, 14 and 21 days
Title
Levels of inflammatory cytokines IL-6, IL-2, IL-7, IL-10,granulocyte-colony stimulating factor (GM-CSF), interferon-γ (IFN-γ) and Tumor Necrosis Factor (TNF-α) from baseline to 7, 14 and 21 days
Description
Levels of inflammatory cytokines IL-6, IL-2, IL-7, IL-10,granulocyte-colony stimulating factor (GM-CSF), interferon-γ (IFN-γ) and Tumor Necrosis Factor (TNF-α) from baseline to 7, 14 and 21 days
Time Frame
1,7,14 and 21 days
Title
Levels of total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort
Description
Levels of total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days
Time Frame
1,7,14 and 21 days
Title
Levels of hemoglobin count (g/dl) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort
Description
Levels of hemoglobin count (g/dl) from baseline to 7, 14 and 21 days
Time Frame
1,7,14 and 21 days
Title
Total platelets count (1000 per mm³) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort
Description
Total platelets count (1000 per mm³) from baseline to 7, 14 and 21 days
Time Frame
1,7,14 and 21 days
Title
Levels of fibrinogen (g/L) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in
Description
Levels of fibrinogen (g/L) from baseline to 7, 14 and 21 days
Time Frame
1,7,14 and 21 days
Title
Levels of D-Dimer (µg/mL) from baseline to 7, 14 and 21 days
Description
Levels of D-Dimer (µg/mL) from baseline to 7, 14 and 21 days
Time Frame
1,7,14 and 21 days
Title
Levels of Ferritin (µg/mL) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort
Description
Levels of Ferritin (µg/mL) from baseline to 7, 14 and 21 days
Time Frame
1,7,14 and 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 immediately after contact and prior to start treatment of the study. Cohort 2: males and females between 18 years and 85 years of age; positive RT-PCR COVID-19 test and medical history and physical exam compatible with asymptomatic or mild COVID-19 pneumonia. Evaluation of clinical outcomes: oxygen requirements, hospitalization breathless and others; Female subjects of childbearing potential must : have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study supplementation; no breast-feeding; agree to use one of the following methods of contraception from enrollment in study until 30 days after last supplementation (only if in sexual relationships with men): hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); or abstinence; bilateral tubal ligation (if no conception post-procedure); tubal occlusion; or bilateral salpingectomy. Women are considered non-child-bearing potential if they are post-menopausal (defined as at least 12 months spontaneous amenorrhea and confirmed with FSH > 40 mIU/ml) or have had documented hysterectomy and/or oophorectomy. system (IUS); vasectomized partner (6 months minimum); or abstinence; bilateral tubal ligation (if no conception post-procedure); tubal occlusion; or bilateral salpingectomy; Normal laboratory values of sodium, potassium, ALT, AST, total bilirubin, alcaline phosphatase, creatinine, fasting glucose, total WBC count, hemoglobina and platelet count; No medical history of alcohol or drug abuse Exclusion Criteria: Hormonal replacement therapy; Severe COVID-19 pneumonia according to CDC criteria; Positive test for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies; Participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to Screening; Immunosuppressive cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to Screening; Subjects 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; Medication or supplements that may interfere with the evaluation of the safety and tolerability of the study drug such as ACE Inhibitors, Angiotensin II Receptor Blockers (ARBs) (e.g. vitamin B3 and L-carnitine/acetyl-carnitine).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Badaró, Ph.D
Organizational Affiliation
SENAI CIMATEC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Senai Cimatec
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41650-010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Clinical Study to Evaluate the Effect of Food Supplement in People Infected With Coronavirus

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