Trial abstract · §2
TA1-SEPSIS-CN — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Randomised, double-blind, placebo-controlled, parallel-group
- Masking
- Double-blind (participant, investigator and sponsor)
- Arms
- 2
- Allocation
- Randomised between the intervention and its comparator
- Endpoint adjudication
- Not applicable to the primary endpoint of this design
- Data monitoring
- As specified in the protocol
§2.2Arms
Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| Thymosin alpha-1 | 158 | 43.8 % | Intervention at the dose reached after titration |
| Placebo | 203 | 56.2 % | Matched placebo, administered on the same schedule |
| Randomised total 361 as published. Arm-level splits are reconstructed and are not published figures. | |||
§2.3Population
Indication. Immune modulation and adjunctive immunotherapy
Pharmacological modification of innate or adaptive immune function, assessed by cell counts, functional assays and clinical infection or oncological endpoints.
Geographic footprint. Netherlands · Belgium · Italy · Poland · Japan · India.
§2.4Eligibility as the Institute reads it
- Included. Pharmacological modification of innate or adaptive immune function, assessed by cell counts, functional assays and clinical infection or oncological endpoints.
- Excluded. Participants for whom the intervention is contraindicated, including known hypersensitivity. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.
Compound Evidence Institute · CEI-TR-0121/2 · https://compoundevidence.com/trials/ta1-sepsis-cn/design/ · retrieved 30 July 2026