Viewing Study NCT04487444



Ignite Creation Date: 2024-05-06 @ 2:59 PM
Last Modification Date: 2024-10-26 @ 1:41 PM
Study NCT ID: NCT04487444
Status: TERMINATED
Last Update Posted: 2023-02-14
First Post: 2020-07-22

Brief Title: Thymalfasin Thymosin Alpha 1 to Treat COVID-19 Infection
Sponsor: Rhode Island Hospital
Organization: Rhode Island Hospital

Study Overview

Official Title: A Pilot Trial of Thymalfasin Ta1 to Treat COVID-19 Infection in Patients With Lymphocytopenia
Status: TERMINATED
Status Verified Date: 2022-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: The study was terminated due to slow enrollment and the transfer of the PI to another institution
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Ta1
Brief Summary: 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 16 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
Detailed Description: Ta1 is a naturally occurring peptide that has been evaluated for its immunomodulatory activities and related therapeutic potential in several conditions and diseases including infectious disease and cancer ZADAXIN brand Ta1 is a synthetic version currently approved for use in 37 countries in particular it is approved in China for treatment of hepatitis B and to enhance vaccine response Notably Ta1 has been used clinically in pilot studies for treatment of severe acute respiratory syndrome SARS and other lung infections including acute respiratory distress syndrome ARDS and chronic obstructive pulmonary disorder COPD as well as infections after bone marrow transplant Larger clinical trials have shown significant efficacy for treatment of severe sepsis and hepatitis B along with certain cancers such as melanoma hepatocellular and lung cancer Ta1 has also demonstrated improvement in response to vaccines in the elderly and in patients immunocompromised by renal disease

Ta1 restores immune system homeostasis by acting as multi-tasking protein depending on the host state of inflammation or immune dysfunction such as infectious disease and cancer Ta1 is believed to directly enhance the immune systems recognition of infected cells and tumors cells while also possibly modulating T cell activity and stimulating both innate and adaptive immunity to clear bacteria virus fungi and tumor cells Ta1 serves a unique function in balancing pro-inflammatory and anti-inflammatory cytokine production through the regulation of distinct Toll-like receptors TLRs on different dendritic cell subsets Data from other coronaviruses such as SARS-CoV and Middle Eastern respiratory syndrome MERS-CoV indicate that infection relies on their ability to impair both innate and adaptive immunity During the 2003 pandemic Ta1 was used as a prophylactic agent against SARS Some published reports suggest that timely administration of immune-enhancers such as Ta1 to SARS patients was efficacious to a certain extent in controlling the development of the disease Another study investigated the clinical manifestations pharmacotherapy and prognosis of 46 patients with SARS and divided the severe cases 22 cases into 2 groups according to administration of Ta1 and showed that the incidence rate of pulmonary fibrosis was lower in the group with Ta1 2 of 14 cases than the group without 6 out of 8 cases ie 143 and 750 respectively

A recent study presented a retrospective analysis of hospitalized COVID-19 patients in China in which those treated with Ta1 showed an improvement in lymphocyte subsets as well as a significant reduction in mortality from 30 to 11 p 004

Based on post-marketing treatment experience of more than 600000 patients Ta1 has been well tolerated Ta1 has been administered to elderly subjects up to 101 years old children as young as 13 months and immunocompromised patients The most common adverse events AEs in previous clinical trials include injection-site pain such as burning and itching which was mild and lasted for less than 30 minutes as well as fever nausea and flu-like symptoms which were mild to moderate in severity Thus while Ta1 is one of only a few immunomodulatory agents that have been approved for human use it does not appear to induce most of the side effects and toxicities commonly associated with other biological response modifiers BRMs in this class such as interferon and interleukin IL-2

The primary objective of the study is to determine whether Ta1 administered daily for one week to hospitalized COVID-19 patients with lymphocytopenia will improve time to recovery free of respiratory failure compared with a similar population of patients who do not receive Ta1 The secondary objectives are to determine whether hospitalized COVID-19 patients with lymphocytopenia treated with Ta1 will have a milder course of infection in terms of length of hospitalization stay requirement and length for ICU stay and requirement for supplemental oxygen or mechanical ventilation than patients not treated with Ta1 as well as higher chances of survival

After screening hospitalized patients with COVID-19 and lymphocytopenia who meet the inclusion criteria will receive Ta1 16 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 After the treatment period all subjects will be followed and evaluated for efficacy outcomes at Day 14 with follow-up visits at Days 28 42 and 60 by phone if the subject has been discharged from the hospital to determine any AEserious adverse event SAE and mortality

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None