Trial Outcomes & Findings for Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients (NCT NCT04428008)
NCT ID: NCT04428008
Last Updated: 2026-04-21
Results Overview
Number of subjects who become infected with COVID-19 over the course of the study
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
189 participants
Primary outcome timeframe
6 months
Results posted on
2026-04-21
Participant Flow
There were 189 eligible participants available for study during the recruitment period.
Participant milestones
| Measure |
Active Arm: Thymalfasin
1.6 mg thymalfasin in 1 mL subcutaneous injection twice weekly after dialysis for 8 weeks, 91 participants enrolled and completed analysis.
|
Control Arm
Standard care; 98 participants enrolled and completed analysis.
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
98
|
|
Overall Study
COMPLETED
|
75
|
81
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients
Baseline characteristics by cohort
| Measure |
Active Arm
n=91 Participants
1.6 mg thymalfasin in 1 mL subcutaneous injection twice weekly after dialysis for 8 weeks
|
Control Arm
n=98 Participants
Standard care
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 Years
STANDARD_DEVIATION 11.9 • n=13 Participants
|
59 Years
STANDARD_DEVIATION 12.9 • n=13 Participants
|
59.5 Years
STANDARD_DEVIATION 12.4 • n=26 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=13 Participants
|
38 Participants
n=13 Participants
|
77 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=13 Participants
|
60 Participants
n=13 Participants
|
112 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
70 Participants
n=13 Participants
|
71 Participants
n=13 Participants
|
141 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=13 Participants
|
23 Participants
n=13 Participants
|
39 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
6 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of subjects who become infected with COVID-19 over the course of the study
Outcome measures
| Measure |
Active Arm
n=91 Participants
1.6 mg thymalfasin in 1 mL subcutaneous injection twice weekly after dialysis for 8 weeks
|
Control Arm
n=98 Participants
Standard care
|
|---|---|---|
|
Number of Participants With COVID-19 Infection
|
5 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants who were hospitalized
Outcome measures
| Measure |
Active Arm
n=91 Participants
1.6 mg thymalfasin in 1 mL subcutaneous injection twice weekly after dialysis for 8 weeks
|
Control Arm
n=98 Participants
Standard care
|
|---|---|---|
|
Hospitalization
|
27 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants with non-COVID-19 infections
Outcome measures
| Measure |
Active Arm
n=91 Participants
1.6 mg thymalfasin in 1 mL subcutaneous injection twice weekly after dialysis for 8 weeks
|
Control Arm
n=98 Participants
Standard care
|
|---|---|---|
|
Non-COVID-19 Infections
|
8 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of subjects who died
Outcome measures
| Measure |
Active Arm
n=91 Participants
1.6 mg thymalfasin in 1 mL subcutaneous injection twice weekly after dialysis for 8 weeks
|
Control Arm
n=98 Participants
Standard care
|
|---|---|---|
|
Mortality
|
3 participants
|
7 participants
|
Adverse Events
Active Arm
Serious events: 28 serious events
Other events: 0 other events
Deaths: 3 deaths
Control Arm
Serious events: 26 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Active Arm
n=91 participants at risk
1.6 mg thymalfasin in 1 mL subcutaneous injection twice weekly after dialysis for 8 weeks
|
Control Arm
n=98 participants at risk
Standard care
|
|---|---|---|
|
Nervous system disorders
Acute metabolic encephalopathy
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Nervous system disorders
Altered mental status
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Renal and urinary disorders
Kidney transplant
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Renal and urinary disorders
Renal hemophagocytic cyst
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Renal and urinary disorders
Hyperkalemia
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
2.0%
2/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.4%
4/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
2.0%
2/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
COVID-negative pneumonia
|
4.4%
4/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
5.5%
5/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
7.1%
7/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
2.0%
2/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Fatigue and pneumonia
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
2.2%
2/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Gangrene
|
2.2%
2/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Foot wounds
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Vascular disorders
Inability to access HD graft
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
AV graft thrombosis
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Aortic dissection
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Excess fluid
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Facial and arm swelling
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Chest pain associated with DKA
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Chest pain
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Gastrointestinal disorders
Diarrhea, nausea, and emesis
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Immune system disorders
Sepsis
|
4.4%
4/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Immune system disorders
Systemic inflammatory response syndrome
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Acute gout flare-up
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis of toe
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
2.2%
2/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Nervous system disorders
Seizure
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Hypertensive emergency
|
2.2%
2/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Hemoptysis
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Ischemic stroke
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Heart failure
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Worsening of anemia
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Hypoglycemia
|
2.2%
2/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Endocarditis
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Venous thromboembolism
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
0.00%
0/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
|
Cardiac disorders
AV fistula access issues
|
0.00%
0/91 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
1.0%
1/98 • From the date the subject signed the Informed Consent Form through the 6 month follow-up visit
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place