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ThymalfasinWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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D007239 Infection NIH 0.07

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There are 2 clinical trials

Clinical Trials

1 A Pilot Trial of Thymalfasin (Ta1) to Prevent COVID-19 Infection in Elderly Renal Dialysis Patients

Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN® injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by the thymus gland. Ta1 is a biological response modifier which activates various cells of the immune system, and is therefore expected to have clinical benefits in disorders where immune responses are impaired or ineffective, including acute and chronic viral and bacterial infections, cancers, and vaccine non-responsiveness. Patients with end-stage renal disease (ESRD) on hemodialysis, in addition to their intrinsic kidney disease and frequent burden of comorbidities, also have increased risk of exposure to communicable diseases as they are treated several times each week at hemodialysis centers with several other patients and clinic staff in attendance. The majority of patients are over 60 years of age and many are receiving immunosuppressive medications. Accordingly, ESRD patients are particularly susceptible to COVID-19 infection. Ta1 has been shown to be safely administered to hemodialysis patients. It is our hypothesis that a course of Ta1 administered to individuals with ESRD will reduce the rate and severity of infection with COVID-19.

NCT04428008 COVID-19 Drug: Thymalfasin
MeSH:Infection

Primary Outcomes

Description: Number of subjects who become infected with COVID-19 over the course of the study

Measure: Reduction in documented infection with COVID-19 Reduction in infection with COVID-19

Time: 6 months

Secondary Outcomes

Description: Number of subjects who become hospitalized

Measure: Need for hospitalization

Time: 6 months

Description: If subject becomes hospitalized, what length of time does the subject remain hospitalized

Measure: Hospital length of stay

Time: 6 months

Description: Number of subjects who are entered into the ICU

Measure: Need for ICU admission

Time: 6 months

Description: If subject is entered into the ICU, what length of time does the subject remain in the ICU

Measure: ICU length of stay

Time: 6 months

Description: Number of subjects who require mechanical ventilation

Measure: Need for mechanical ventilation

Time: 6 months

Description: If mechanical ventilation is required, what length of time the ventilation is required

Measure: Duration of mechanical ventilation

Time: 6 months

Description: If subject becomes infected with COVID-19, how long does the subject require to recover from the infection

Measure: Recovery time from COVID-19

Time: 6 months

Description: Evaluation of whether any comorbidities are changed over the course of treatment (eg., worsening of congestive heart failure)

Measure: Change in any existing comorbidities or occurrence of newly diagnosed disease

Time: 6 months

Description: Determination of whether there are more or fewer infections other than COVID-19 (other respiratory, urinary tract, cellulitis, etc.)

Measure: Incidence of non-COVID-19 infections

Time: 6 months

Description: Evaluation of the levels of CD4 and CD8 subjects

Measure: Change in lymphocyte subsets (CD4, CD8)

Time: 6 months

Description: Number of subjects who die during the course of the study

Measure: Mortality

Time: 6 months

Description: Number of subjects with mild, moderate, or severe adverse events based on perceived clinical significance of the event

Measure: Treatment-emergent adverse events

Time: 6 months

Description: Number of subjects with mild, moderate, or severe changes to vital signs based on perceived clinical significance of the event

Measure: Treatment-emergent changes in vital signs

Time: 6 months

Description: Number of subjects with mild, moderate, or severe laboratory findings based on perceived clinical significance of the event

Measure: Treatment-emergent laboratory parameters

Time: 6 months

2 A Pilot Trial of Thymalfasin (Ta1) to Treat COVID-19 Infection in Patients With Lymphocytopenia

It is our hypothesis that a course of Ta1 administered to hospitalized individuals with COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective) and severity of infection (secondary objectives) compared to untreated individuals in the same hospital with comparable lymphocytopenia. After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1 week. Individuals in the control arm will be followed on the identical protocol but will not receive daily Ta1.

NCT04487444 Covid19 Drug: Thymalfasin
MeSH:Infection

Primary Outcomes

Description: Length of time for patient to no longer require supplemental oxygen and can sustain a good oxygen saturation (SpO2) on room air

Measure: Time to recovery (free of respiratory failure)

Time: Day 28

Secondary Outcomes

Description: Evaluation of CD4 and CD8 levels

Measure: Lymphopenia

Time: Day 14

Description: Percentage of subjects still alive

Measure: Survival

Time: Day 28

Description: Length of time before hospital discharge

Measure: Hospital length of stay

Time: Day 28

Description: Number of subjects that require high flow oxygen

Measure: Requirement for high flow oxygen supplementation

Time: Day 28

Description: Number of days that each subject requires high flow oxygen

Measure: Duration of high flow oxygen supplementation

Time: Day 28

Description: Number of subjects that are admitted to the ICU

Measure: ICU admission

Time: Day 28

Description: Number of days that each subject remains in the ICU

Measure: ICU length of stay

Time: Day 28

Description: Number of subjects that require mechanical ventilation

Measure: Mechanical ventilation

Time: Day 28

Description: Number of days that each subject requires the mechanical ventilation

Measure: Duration of mechanical ventilation

Time: Day 28

Description: Number of subjects that have decreases or increases in comorbidities existing at time of enrollment

Measure: Change in any existing comorbidities (e.g., worsening congestive heart failure) or occurrence of newly diagnosed disease

Time: Day 28

Description: Number of subjects who get infections other than COVID-19

Measure: Incidence of non-COVID-19 infections (other respiratory, urinary tract, cellulitis, etc.)

Time: Day 28

Description: Adverse events and serious adverse events experienced by the subjects

Measure: AEs/SAEs

Time: Day 60

Description: Mild, moderate, or severe changes to vital signs (heart rate, blood pressure, temperature, number of respirations per minute) based on perceived clinical significance of the change

Measure: Changes to vital signs

Time: Day 28

Description: Mild, moderate, or severe changes to laboratory parameters (complete blood count and standard chemistry surveys) based on perceived clinical significance of the change

Measure: Changes in laboratory parameters

Time: Day 28

No related HPO nodes (Using clinical trials)