Trial · Interventional

TerminatedPhase 2Registry data

Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection

Short name Ta1

NCTNCT04487444Other idSCN-16130571-2

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: The study was terminated due to slow enrollment and the transfer of the PI to another institution.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 56 participants (actual)
Sponsor: Rhode Island Hospital · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 10 Sept 2020
Primary completion: 3 Feb 2023
Completion: 3 Feb 2023
First posted: 27 Jul 2020
Last update posted: 14 Feb 2023
Conditions: Covid19

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20202021202220232024

Ph 2
Ta1
NCT04487444
10 Sept 2020 to 3 Feb 2023
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

ThymalfasinDrug

Arms2

Experimental
Ta1 treatment arm
Ta1 at a dose of 1.6 mg will be administered SC in 1 mL of diluent daily for a total of 1 week, in addition to standard of care.
No intervention
Control arm
No treatment will be provided in addition to standard of care.

Primary outcomes1

Outcomes the sponsor listed as primary.

Time to recovery (free of respiratory failure)
Time frame · Day 28
Registry description
Length of time for patient to no longer require supplemental oxygen and can sustain a good oxygen saturation (SpO2) on room air

Secondary outcomes(14)

Lymphopenia
Time frame · Day 14
Registry description
Evaluation of CD4 and CD8 levels
Survival
Time frame · Day 28
Registry description
Percentage of subjects still alive
Hospital length of stay
Time frame · Day 28
Registry description
Length of time before hospital discharge
Requirement for high flow oxygen supplementation
Time frame · Day 28
Registry description
Number of subjects that require high flow oxygen
Duration of high flow oxygen supplementation
Time frame · Day 28
Registry description
Number of days that each subject requires high flow oxygen
ICU admission
Time frame · Day 28
Registry description
Number of subjects that are admitted to the ICU
ICU length of stay
Time frame · Day 28
Registry description
Number of days that each subject remains in the ICU
Mechanical ventilation
Time frame · Day 28
Registry description
Number of subjects that require mechanical ventilation
Duration of mechanical ventilation
Time frame · Day 28
Registry description
Number of days that each subject requires the mechanical ventilation
Change in any existing comorbidities (e.g., worsening congestive heart failure) or occurrence of newly diagnosed disease
Time frame · Day 28
Registry description
Number of subjects that have decreases or increases in comorbidities existing at time of enrollment
Incidence of non-COVID-19 infections (other respiratory, urinary tract, cellulitis, etc.)
Time frame · Day 28
Registry description
Number of subjects who get infections other than COVID-19
AEs/SAEs
Time frame · Day 60
Registry description
Adverse events and serious adverse events experienced by the subjects
Changes to vital signs
Time frame · Day 28
Registry 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
Changes in laboratory parameters
Time frame · Day 28
Registry description
Mild, moderate, or severe changes to laboratory parameters (complete blood count and standard chemistry surveys) based on perceived clinical significance of the change

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2023

4 results

A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection.

Shehadeh et al. 2023The Journal of infectious diseasescited by 9

PMID 36056913PMC9494344DOI 10.1093/infdis/jiac362PUB-36056913

Rights unknown4 results

Source link See results (4)

PubMed tag: none · 2020

7 results

Thymosin Alpha 1 Reduces the Mortality of Severe Coronavirus Disease 2019 by Restoration of Lymphocytopenia and Reversion of Exhausted T Cells.

Liu et al. 2020Clinical infectious diseases : an official publication of the Infectious Diseases Society of Americacited by 125

PMID 32442287PMC7314217DOI 10.1093/cid/ciaa630PUB-32442287

Rights unknown7 results

Source link See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Signed informed consent * PCR positive for COVID-19 within the last 4 days * Hospitalized * SpO2 ≤ 93% on room air or requiring supplemental oxygen at screening (i.e. patients with severe disease) * Lymphopenia (total lymphocyte count \< 1.5 × 109/L) Exclusion Criteria: * Patients on mechanical ventilation * Patients who are pregnant or breastfeeding * Patients with multi-organ failure * Patients with advanced malignancy receiving cytotoxic chemotherapy * Patients with prior history of solid organ (kidney, liver, heart, lung, pancreas) or bone marrow transplant * Patients on any other immunomodulatory therapy * Patients receiving Plaquenil * Patients who have participated in an investigational drug or device trial in previous 30 days * Patients with a history of allergy or intolerance to Ta1 * Any other medical or psychiatric condition that, in the opinion of the Investigator, would compromise patient safety or interfere with the objectives of the protocol or completion of the protocol treatment

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