CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Standard of Care Triple ISWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug1559 Lenzilumab Wiki 1.00
drug3498 tocilizumab Wiki 0.71
drug2698 Standard of Care Wiki 0.18
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.06
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.06

There is one clinical trial.

Clinical Trials

1 Targeting Inflammation and Alloimmunity in Heart Transplant Recipients With Tocilizumab (RTB-004)

The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.

NCT03644667 Heart Transplant Biological: tocilizumab Biological: Placebo Drug: Standard of Care Triple IS

Primary Outcomes

Description: This outcome is defined by a composite 1 year post-transplant endpoint of: detection of de novo donor-specific antibodies (dnDSA) (Core Laboratory), acute cellular rejection (ACR) ≥ ISHLT 2R rejection (Core Laboratory), antibody mediated rejection (AMR) ≥ ISHLT AMR 1 (Core Laboratory), hemodynamic compromise rejection in the absence of a biopsy or histological rejection, death, or re-transplantation.

Measure: Proportion of Participants Positive for Event of dnDSA, ACR, AMR, Hemodynamic Compromise, Death or Re-Transplantation - By Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)

Secondary Outcomes

Description: A comparison by treatment group of the incidence of freedom from development of de novo donor-specific antibodies (dnDSA). dnDSA is a newly developed alloantibody that is against the donor organ.

Measure: Freedom of Detection of de Novo Donor-Specific Antibodies (dnDSA) - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)

Description: A comparison by treatment group of the incidence of freedom from development of acute cellular rejection ≥2R (Reference: International Society of Heart and Lung Transplantation [ISHLT] acute cellular rejection-grade 2R or greater severity).

Measure: Freedom from Acute Cellular Rejection (ACR) ≥ International Society of Heart and Lung Transplantation (ISHLT) 2R Rejection - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)

Description: A comparison by treatment group of the incidence of freedom from development of antibody-mediated rejection defined as ISHLT grade AMR 1 or greater severity.

Measure: Freedom from Antibody Mediated Rejection (AMR) ≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1 - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)

Description: A comparison by treatment group of the incidence of freedom from development of hemodynamic compromise (HDC). Hemodynamic compromise is defined by: - Need for inotropic agents due to a Cardiac Index (CI) <2.0 L/min/m^2 or a 25% decrease from baseline, in addition to one of the following: ejection fraction of <40% or a 20% decrease from baseline, and the need for inotropic agents OR fractional shortening of <20% or a 25% decrease from baseline, and the need for inotropic agents.

Measure: Freedom from Hemodynamic Compromise Rejection in the Absence of a Biopsy or Histological Rejection - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)

Description: A comparison by treatment group of the incidence of freedom from development of episode of rejection requiring treatment. Reference: Acute cellular rejection as defined by the 2004 International Society of Heart and Lung Transplantation (ISHLT) grading scale.

Measure: Freedom from Any-Treated Rejection - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)

Description: A comparison by treatment group of the incidence of freedom from acute cellular rejection (ACR) ≥ ISHLT 2R rejection. Reference: 2004 International Society of Heart and Lung Transplantation [ISHLT [ grading scale).

Measure: Freedom from Acute Cellular Rejection (ACR) ≥ International Society of Heart and Lung Transplantation (ISHLT) 2R Per Patient - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)

Description: Time from transplant, free of antibody mediated rejection, defined as ISHLT grade AMR 1 or greater will be compared between the treatment groups. Hemodynamic compromise is defined as the need for inotropic agents due to a Cardiac Index (CI) <2.0 L/min/m2 or a 25% decrease from baseline in addition to one of the following: Ejection fraction of <40% or a 20% decrease from baseline, and the need for inotropic agents Fractional shortening of <20% or a 25% decrease from baseline, and the need for inotropic agents

Measure: Freedom from Antibody Mediated Rejection (AMR) (≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1) Per Participant - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)]

Description: Time from transplant, free of antibody mediated rejection, defined as ISHLT grade AMR 1 or greater will be compared between the treatment groups

Measure: Freedom from Hemodynamic Compromise Rejection in the Absence of a Biopsy or Histological Rejection Per Participant - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)

Description: Incidence of all-cause mortality will be compared between the treatment groups.

Measure: Occurrence of Death - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)

Description: Incidence of participant(s) being re-listed for transplant will be compared between the treatment groups.

Measure: Occurrence of Re-Listed for Transplantation - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)

Description: Incidence of participant(s) re-transplantation will be compared between the treatment groups.

Measure: Occurrence of Re-Transplantation - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)]

Description: The frequency of events will be compared between the treatment groups.

Measure: Number of Acute Cellular Rejection (≥ International Society of Heart and Lung Transplantation (ISHLT) 2R) Per Patient - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)]

Description: The frequency of events will be compared between the treatment groups.

Measure: Number of Antibody Mediated Rejection (AMR) (≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1) Per Participant - by Treatment Group

Time: 12 months post-transplantation

Description: The frequency of events will be compared between the treatment groups.

Measure: Number of Rejection Episodes Associated with Hemodynamic Compromise (HDC) Per Participant - by Treatment Group

Time: From transplant through 12 months post transplant surgery (12 months)]

Description: Per protocol, per clinical research site standard of care.

Measure: Change in Intravascular Ultrasound (IVUS) Measurements From Baseline to 1 Year Post-Transplant- by Treatment Group

Time: Baseline (4 to 8 weeks post-transplant), 1 year post-transplant

Description: In accordance with the International Society of Heart and Lung Transplantation (ISHLT) Cardiac Allograft Vasculopathy (CAV) angiographic grading scale.

Measure: Angiographic Evidence of Cardiac Allograft Vasculopathy (CAV) - by Treatment Group

Time: 12 months post-transplantation

Description: Incidence of participant loss to follow up will be compared between the treatment groups.

Measure: Participant Loss to follow up - by Treatment Group

Time: 12 months post-transplantation

Description: The frequency of serious infections requiring intravenous antimicrobial therapy and need for hospitalization will be compared between treatment groups.

Measure: Occurrence of Serious Infections Requiring Intravenous Antimicrobial Therapy and Need for Hospitalization - by Treatment Group

Time: Through 24 months post transplant surgery

Description: The incidence of tuberculosis will be compared between treatment groups.

Measure: Incidence of Tuberculosis - by Treatment Group

Time: Through 24 months post transplant surgery

Description: The incidence of CMV infection will be compared between treatment groups.

Measure: Incidence of Cytomegalovirus (CMV) Infection - by Treatment Group

Time: Through 24 months post transplant surgery

Description: The incidence of PTLD will be compared between treatment groups.

Measure: Incidence of Post-Transplant Lymphoproliferative Disease (PTLD) - by Treatment Group

Time: Through 24 months post transplant surgery

Description: The number of participants who discontinue study drug, per protocol, will be compared between treatment groups.

Measure: Tolerability (Discontinuation of Study Drug) of Tocilizumab (TCZ) - by Treatment Group

Time: Through 24 months post transplant surgery

No related HPO nodes (Using clinical trials)