A pilot trial of Thymalfasin (Ta1) to prevent covid-19 infection and morbidities in renal dialysis patients: Preliminary report.

Pilot clinical trial randomizing hemodialysis patients to Thymalfasin or control

“With this in mind, a pilot clinical trial was begun in early 2021 to investigate the possible efficacy of Thymalfasin (thymosin alpha 1 or Ta1) in reducing the rate or severity of infection by COVID-19 in individuals with end-stage renal disease (ESRD) on hemodialysis (HD).”

Patients with end-stage renal disease on hemodialysis aged 18 or older

“Patients with ESRD, receiving hemodialysis 2 or more times each week and expected to continue on dialysis indefinitely.”

194 patients randomized from 254 screened

“Of these, 194 patients have been randomized 1:1 to either Group A (1.6 mg Ta1 given subcutaneously twice weekly for 8 weeks), or Group B (control group not receiving Ta1).”

8 weeks of treatment followed by 4 months of monitoring

“After the 8-week treatment period, subjects were followed for an additional 4 months and monitored for safety and efficacy.”

Fewer deaths occurred in the Thymalfasin group compared to the control group

“To date, only 3 deaths have occurred in subjects treated with Ta1 (Group A), compared to 7 in the control (Group B).”

Serious adverse events were similar in number between the two groups

“The number of subjects who suffered serious adverse events was essentially the same in the two groups; 27 subjects in the Ta1 group (Table 1 ) and 26 in the control group (Table 2 ).”

Final efficacy analysis regarding infection rates and antibody response is pending

“As the follow-up period is still ongoing, the analysis of efficacy endpoints has yet to be conducted.”

Efficacy endpoints have not been fully analyzed as the follow-up period is ongoing

“As of the date of this publication, the follow-up time period is ongoing and therefore the analysis of efficacy endpoints has yet to be completed.”