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NCT05531149: TRICOVID
Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia
Phase 3 trial testing Trimodulin in Respiratory Infection in 107 participants. Terminated before completion.
5 May 2025
Quick facts
| Lead sponsor | Biotest |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 107 |
| Start date | 22 December 2022 |
| Primary completion | 5 May 2025 |
| Estimated completion | 5 May 2025 |
| Sites | 64 locations across France, South Africa, Slovakia, Belgium, Austria, Germany, Hungary, Argentina |
Drugs / interventions tested
- Trimodulin — full drug profile →
- Placebo (human albumin 1%) — full drug profile →
Conditions studied
- Respiratory Infection — all drugs for Respiratory Infection →
- Pneumonia — all drugs for Pneumonia →
- Community-acquired Pneumonia — all drugs for Community-acquired Pneumonia →
- Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
Sponsor
Biotest — full company profile →
Who can join
18 and older, any sex, with Respiratory Infection or Pneumonia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
A new hope? Possibilities of therapeutic IgA antibodies in the treatment of inflammatory lung diseases.
Bohländer F. · · 2023 · cited 18× · PMID 37051237 · DOI 10.3389/fimmu.2023.1127339 -
Review of COVID-19 Therapeutics by Mechanism: From Discovery to Approval.
Choi HS, Choi AY, Kopp JB, Winkler CA, et al · · 2024 · cited 13× · PMID 38622939 · DOI 10.3346/jkms.2024.39.e134 -
Understanding IgM Structure and Biology to Engineer New Antibody Therapeutics.
Buchner J, Sitia R, Svilenov HL. · · 2025 · cited 8× · PMID 40237925 · DOI 10.1007/s40259-025-00720-6 -
Biochemical Characterization of a New 10% IVIG Preparation [IgG Next Generation (BT595)/Yimmugo<sup>®</sup>] Obtained from a Manufacturing Process Preserving IgA/IgM Potential of Human Plasma.
Duellberg C, Hannappel A, Kistner S, Maneg O. · · 2023 · cited 5× · PMID 37466834 · DOI 10.1007/s40268-023-00430-w -
Efficacy and safety of trimodulin in patients with severe COVID-19: results from a randomised, placebo-controlled, double-blind, multicentre, phase II trial (ESsCOVID).
Agafina A, Aguiar VC, Rossovskaya M, Fartoukh MS, et al · · 2024 · cited 2× · PMID 39138518 · DOI 10.1186/s40001-024-02008-x -
Trimodulin supports antibacterial defence and restricts inflammation in preclinical pneumonia models.
Nouailles G, Bischoff R, Linke K, Taylor A, et al · · 2026 · PMID 40935582 · DOI 10.1183/13993003.00392-2025
Verify or expand the search:
- PubMed search for NCT05531149
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Trimodulin
Trials testing the same drug.
- NCT05722938 — Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) · Phase 3 · recruiting
- NCT04576728 — Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19 · Phase 2 · completed
Other recruiting trials for Respiratory Infection
Currently open trials in the same condition.
- NCT06390878 — Nationwide Research on the Rewilding of Kindergarten Yards · NA · recruiting
- NCT05860387 — Early Diagnosis of Invasive Lung Aspergillosis · recruiting
Other Biotest trials
Trials by the same sponsor.
- NCT05722938 — Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) · Phase 3 · recruiting
- NCT05170269 — Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion) · Phase 3 · terminated
- NCT04576728 — Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19 · Phase 2 · completed
- NCT03444324 — Adjusted Fibrinogen Replacement Strategy · Phase 3 · completed
- NCT02810444 — Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05531149 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Biotest
- Last refreshed: 8 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05531149.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing