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Respiratory InfectionPhase 3TRICOVIDNCT05531149

Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia

A Phase 3 study testing Trimodulin in people with Respiratory Infection and Pneumonia, run by Biotest at 64 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trimodulin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
107 participants
Where
64 sitesin 14 countries
Study dates
22 Dec 2022to 5 May 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Written informed consent.
  2. Hospitalized, adult (≥ 18 years of age) subjects.
  3. Diagnosis of CAP or COVID- 19 pneumonia (e.g. according to local guidelines) and with radiologic evidence showing new pulmonary lobar or multilobar infiltrates consistent with CAP or COVID-19 pneumonia.
  4. Receiving oxygen supply via low-flow oxygen, 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).
  6. Signs of early systemic inflammation based on CRP and coagulation parameter threshold levels.

Main Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Subject on invasive mechanical ventilation and/or extracorporeal membrane oxygenation.
  3. Subject with septic shock and in need for vasopressors.
  4. Severe neutropenia prior to start of treatment.
  5. Hemoglobin >7 g/dL prior to start of treatment.
  6. Pre-existing hemolytic disease.
  7. Pre-existing thromboembolic events (TEEs).
  8. Subject on dialysis or with severe renal impairment prior to start of treatment.
  9. Subject with end stage renal disease, or known primary focal segmental glomerulosclerosis.
  10. Pre-existing severe lung diseases to current pneumonia.
  11. Pre-existing decompensated heart failure.
  12. Pre-existing hepatic cirrhosis, severe hepatic impairment , or hepatocellular carcinoma.
  13. Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin/placebo.
  14. Selective, absolute immunoglobulin A (IgA) deficiency with known antibodies to IgA.
  15. Known human immunodeficiency virus infection.
  16. Life expectancy of less than 90 days.
  17. Morbid obesity or malnutrition.
  18. Treatment with predefined medications (certain immune modulators or immunosuppressants) before entering the trial.

Trial locations and contacts

64 sites in 14 countries.

64 sites in 14 countries

Brazil11 sites

  • Investigational Site #5505

    Botucatu, 18618-686

  • Investigational Site #5508

    Campo Largo, São Paulo, 83606-177

  • Investigational Site #5503

    Porto Alegre, 90020-090

  • Investigational Site #5507

    Porto Alegre, 90035-903

  • Investigational Site #5506

    Porto Alegre, 90610-000

  • Investigational Site #5509

    Ribeirão Preto, São Paulo, 14048-900

  • Investigational Site #5502

    Santo André, 09030-10

  • Investigational Site #5510

    Santos, 11075-101

  • Investigational Site #5504

    São José do Rio Preto, 15090-000

  • Investigational Site #5511

    São Paulo, São Paulo, 01323-903

  • Investigational Site #5501

    São Paulo, 09530-700

Other trials in Brazil

France8 sites

  • Investigational Site #3303

    Melun, 77000

  • Investigational Site #3304

    Paris, 75020

  • Investigational Site #3301

    Paris, 75877

  • Investigational Site #3305

    Saint-Etienne, 42055

  • Investigational Site #3307

    Salouël, 80054

  • Investigational Site #3306

    Strasbourg, 67091

  • Investigational Site #3308

    Strasbourg, 67098

  • Investigational Site #3302

    Trévenans, 90400

Other trials in France

Lithuania7 sites

  • Investigational Site #7002

    Kaunas, 47116

  • Investigational Site #7007

    Kaunas, LT-44320

  • Investigational Site #7005

    Kaunas, LT-50161

  • Investigational Site #7003

    Klaipėda, LT-92288

  • Investigational Site #7004

    Šiauliai, LT-76231

  • Investigational Site #7006

    Vilnius, 08661

  • Investigational Site #7001

    Vilnius, LT-08406

Other trials in Lithuania

South Africa7 sites

  • Investigational site #2706

    Kimberley, 8301

  • Investigational Site #2702

    Klerksdorp, 1864

  • Investigational Site #2703

    Mthatha, 5100

  • Investigational Site #2705

    Plettenberg Bay, 6600

  • Investigational Site #2701

    Pretoria, 0001

  • Investigational Site #2707

    Pretoria, 0002

  • Investigational Site #2704

    Pretoria, 0204

Other trials in South Africa

Germany5 sites

  • Investigational Site #4904

    Berlin, 10117

  • Investigational Site #4901

    Bochum, 44892

  • Investogational Site #4902

    Cottbus, 03048

  • Investigational Site #4903

    Hanover, 30625

  • Investigational Site #4907

    München, 81377

Other trials in Germany

Slovakia5 sites

  • Investigational Site #2103

    Banská Bystrica, 97517

  • Investigational Site #2102

    Malacky, 90122

  • Investigational Site #2105

    Michalovce, 07101

  • Investigational Site #2101

    Nitra, 95991

  • Investigational Site #2104

    Svidník, 08901

Other trials in Slovakia

Argentina3 sites

  • Investigational Site #5401

    Buenos Aires, 1602

  • Investigational Site #5403

    Córdoba, 5000

  • Investigational Site #5402

    Córdoba, X5021FPQ

Other trials in Argentina

Austria3 sites

  • Investigational Site #4303

    Klagenfurt, 9020

  • Investigational Site #4302

    Linz, 4020

  • Investigational Site #4304

    Vienna, 1090

Other trials in Austria

Belgium3 sites

  • Investigational Site #3203

    Edegem, 2650

  • Investigational Site #3202

    Mechelen, 2800

  • Investigational Site #3201

    Ottignies, 1340

Other trials in Belgium

Spain3 sites

  • Investigational Site #3401

    Barcelona, 08036

  • Investigational Site #3403

    Madrid, 28040

  • Investigational Site #3404

    Madrona, 28222

Other trials in Spain

Turkey (Türkiye)3 sites

  • Investigational Site #9005

    Ankara, 06800

  • Investigational Site #9004

    Istanbul, 34303

  • Investigational Site #9001

    Trabzon, 61100

Other trials in Turkey (Türkiye)

Hungary2 sites

  • Investigational SIte #3603

    Debrecen, 4031

  • Investigational Site #3601

    Szeged, 6725

Other trials in Hungary

Latvia2 sites

  • Investigational Site #7102

    Daugavpils, LV-5417

  • Investigational Site #7101

    Riga, LV-1002

Other trials in Latvia

Portugal2 sites

  • Investigational Site #3502

    Guimarães, 4835-044

  • Investogational SIte #3501

    Lisbon, 1500-650

Other trials in Portugal

About this study

Official title: A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase III Trial to Assess the Efficacy and Safety of Trimodulin (BT588) in Adult Hospitalized Subjects With CAP Including COVID-19 Pneumonia.

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.

Read the detailed description

This is a randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin compared to placebo treatment, adjunctive to SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Patients requiring low-flow oxygen, non-invasive ventilation or high-flow oxygen and with signs of early systemic inflammation (defined by C reactive protein (CRP), D-dimer and platelet levels) will be enrolled.

Subjects will be randomized to receive either trimodulin or placebo on a 1:1 basis, stratified by type of oxygen supply before randomization and by region. Investigational Medicinal Product (IMP) treatments will be blinded. Subjects will be administered IMP once daily on five consecutive days (day 1 through day 5) adjunctive to SoC. The subsequent follow-up phase comprises maximally 23 days (day 6 through day 28) followed by an end-of-follow-up visit/telephone call on day 29 [+3]. For all subjects still in the hospital after day 29, an extended follow-up visit is conducted until day 90 or until discharge. For all subjects a closing visit/telephone call on day 91 [+10] will be done.

For the evaluation of the primary and several secondary endpoints of the trial, a 9-category ordinal scale will be used. The primary objective is to assess efficacy of trimodulin based on clinical deterioration and mortality to demonstrate superiority to treatment with placebo. Secondary objectives are to assess efficacy and safety and to determine PK and PD properties of trimodulin compared to placebo.

Being tested
Trimodulin, Placebo (human albumin 1%)
Keywords
Non severe community acquired pneumonia, COVID-19, SARS-CoV-2, CAP
Medical subject headings
Respiratory Tract Infections, Pneumonia, Community-Acquired Pneumonia, Respiratory Distress Syndrome, COVID-19, Pneumonia, Viral, Pneumonia, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrimodulinDrug

    Also called BT588

    IMP will be administered via IV infusion on 5 consecutive days

  • Placebo (human albumin 1%)Drug

    IMP will be administered via IV infusion on 5 consecutive days

Study groups in NCT05531149
Study groupRoleWhat they receive
TrimodulinExperimentalTrimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration.
Receives: Drug: Trimodulin
PlaceboPlacebo comparatorHuman albumin 1%
Receives: Drug: Placebo (human albumin 1%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Endpoint

    Composite of percentage of subjects with a change of at least 1 category on the 9-category ordinal scale from baseline (between days 6-29) and 28-day all-cause mortality rate (between days 1-29)

    Measured: Until day 29

Secondary outcomes (21)

  1. Clinical deterioration rate

    Percentage of subjects with a change of at least 1 category on the category ordinal-scale

    Measured: Between days 6-29 and days 1-29

  2. 28-days all-cause mortality rate

    Percentage of subjects with a change to 8 on 9-category ordinal scale.

    Measured: Day 29

  3. 90-days all-cause mortality rate

    Percentage of subjects with a change to 8 on 9-category ordinal scale.

    Measured: Day 91

  4. Time to recovery

    Number of days to score ≤ 2 until day 29

    Measured: Between days 1-29

  5. Proportion of subjects with score ≤ 2

    Proportion of subjects that improved to score ≤ 2

    Measured: Day 29

  6. Proportion of subjects improved, unchanged, and deteriorated/died

    Proportion of subjects improved, unchanged, and deteriorated/died compared to baseline at several days

    Measured: Between days 1-29

  7. Proportion of subjects with different partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FiO2) ratios

    Proportion of subjects with PaO2/FiO2 ratio < 100, 100 to < 200, 200 to < 300 or ≥ 300

    Measured: Days 7, 14, 21, 29

  8. Days of invasive mechanical ventilation (IMV)/ extracorporeal membrane oxygenation (ECMO)

    Days of IMV/ECMO

    Measured: Day 29

  9. Proportion of subjects on IMV/ECMO

    Proportion of subjects on IMV/ECMO

    Measured: Day 29

  10. Days with oxygen supply

    Days with oxygen supply

    Measured: Day 29

  11. Proportion of subjects with oxygen supply

    Proportion of subjects with oxygen supply

    Measured: Days 7, 14, 21, 29

  12. Days in intensive care unit (ICU)

    Days in intensive care unit

    Measured: Day 29

  13. Proportion of subjects in ICU

    Proportion of subjects in ICU

    Measured: Day 29

  14. Days of hospitalization

    Days of hospitalization

    Measured: Day 29

  15. All adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent withdrawal of IMP and/or discontinuation of trial

    Number, severity, causality, outcome, and seriousness of all adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent withdrawal of IMP, and TEAEs that led to discontinuation of the trial

    Measured: Until day 29

  16. TEAEs

    Number of all related TEAEs

    Measured: Until day 29

  17. SAEs

    Number, severity, causality, and outcome of all serious adverse events (SAEs)

    Measured: Until day 29

  18. Dose modifications

    Dose modifications (incl. reductions and changes in infusion rate)

    Measured: Day 1-5

  19. Change over time in ECG parameters

    ECG recordings, (including heart rate, QT-interval, QTcF) showing abnormal, clinically relevant findings will be reported as adverse event

    Measured: Days -1, 1, 3, 5 and once between days 8-13

  20. Changes over time in vital signs

    Changes in recordings of vital sign parameters showing clinically significant measurements outside the normal range will be reported as adverse event.

    Measured: Days -1,1-3, 5, 7 ,14, 21, 29

  21. Changes over time in clinical laboratory parameters

    Changes in recordings for clinical laboratory values (including chemistry, hematology and coagulation) showing clinically significant measurements outside the normal range will be reported as adverse event.

    Measured: Days -1, 1-5, 7,14, 21, 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2022
  2. Study start22 Dec 2022
  3. Primary completion5 May 2025
  4. Study completion5 May 2025

Why it stopped: Unacceptable delay of trial completion Low recruitment rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized to receive either trimodulin or placebo on a 1:1 basis, stratified by type of oxygen supply before randomization and by region
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05531149
Sponsor's protocol ID
1001
Acronym
TRICOVID
Status last verified
Jun 2025
First submitted
26 Aug 2022
Last updated
8 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trimodulin in people with Respiratory Infection and Pneumonia, run by Biotest at 64 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Brazil, France, Lithuania, South Africa, Germany and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Unacceptable delay of trial completion Low recruitment rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Endpoint (time frame: Until day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05531149.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.

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