Efficacy and Safety of Trimodulin (BT588) in Subjects With Moderate or Severe COVID-19

• Status: Not yet recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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 moderate or severe COVID-19.

Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotest

Criteria

Main Inclusion Criteria:

1. Written informed consent.

2. Hospitalized, adult (≥ 18 years of age) subjects.

3. Laboratory-confirmed acute severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

4. Receiving oxygen supply via low-flow or high-flow oxygen or on non-invasive ventilation.

5. Fulfilling at least one clinical respiratory parameter (SpO2 ≤ 94% and/or 100 mm Hg < PaO2/FiO2 ≤ 300 mm Hg and/or radiologic evidence of COVID-19 pneumonia)

6. Signs of early systemic inflammation based on CRP and coagulation parameter threshold levels.

Main Exclusion Criteria:

1. Pregnant or lactating women.

2. Defined neutrophil counts within 24 hours prior to start of treatment.

3. Defined hemoglobin within 24 hours prior to start of treatment.

4. Known hemolytic disease.

5. Known thrombosis or acute thromboembolic events (TEEs) or known medical history of TEEs or subjects particularly at risk for TEEs caused by other reasons than the current COVID-19 infection.

6. Subject on dialysis or with severe renal impairment within 24 hours prior to start of treatment.

7. Subject with end stage renal disease (ESRD), or known primary focal segmental glomerulosclerosis (FSGS).

8. Known severe lung diseases interfering with COVID-19 therapy (e.g. certain stage of chronic obstructive pulmonary disease (COPD), severe interstitial lung disease, cystic fibrosis, idiopathic pulmonary fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer).

9. Known decompensated heart failure.

10. Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh C score ≥ 9 points), or hepatocellular carcinoma.

11. Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin.

12. Selective, absolute immunoglobulin A (IgA) deficiency with known antibodies to IgA.

13. Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months.

14. Known human immunodeficiency virus infection.

15. Life expectancy of less than 90 days, according to the Investigator's clinical judgment, because of medical conditions neither related to COVID-19 nor to associated medical complications.

16. Morbid obesity with high body mass index ≥ 40 kg/m², or malnutrition with low body mass index < 16 kg/m².

17. Known treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before entering the trial.

18. Known treatment with exploratory selective immune suppressors (cytokine inhibitors, cytokine receptor inhibitors, kinase inhibitors) during the last 10 days before entering the trial.

19. Known treatment predefined medications during the last 5 days before entering the trial.

20. Known treatment with any type of interferon during the last 21 days before entering the trial.

21. Known treatment with immunosuppressants other than guideline recommended immunosuppressants for treatment of acute COVID-19.

22. Participation in another interventional clinical trial within 30 days before entering, or previous participation in this clinical trial.