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Primary objectives Part 1:
- To evaluate the safety and tolerability of COR-101 compared to placebo
Secondary objectives Part 1:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | COR-101 low dose |
|
| Cohort 2 | Experimental | COR-101 mid dose 1 |
|
| Cohort 3 | Experimental | COR-101 mid dose 2 |
|
| Cohort 4 | Experimental | COR-101 high dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COR-101 | Drug | Administered intravenously (IV) single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Treatment-Emergent Adverse Events (TEAEs) | through Day 28 | |
| Proportion of patients with Serious Adverse Events (SAEs) | through Day 28 | |
| Proportion of patients with Adverse Events of Special Interest (AESI) | through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy endpoint: Proportion of patients with disease progression | Proportion of patients who are not alive or have respiratory failure | through Day 28 |
| Secondary efficacy endpoint: Time to negative RT-PCR for SARS-CoV-2 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Ann Dhaen | Contact | +4981313563724 | m.dhaen@corat-therapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Helmut Salih | University Hospital Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tübingen | Recruiting | Tübingen | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41654452 | Derived | Marconato M, Hackenbruch C, Jager S, Gopel S, capital KA, Cyrillicirieieva T, Gavrylov A, Fricke H, Hust M, Dubel S, Dings C, Lehr T, Cuevas M, Bitzer M, Klein C, Schwab M, Wirtz H, Schneider J, Bitter T, Frenzel A, Dhaen MA, Herrmann A, Jung G, Walz JS, Salih HR, Heitmann JS. Phase I Study Evaluating a Monoclonal Fc-Silenced SARS-CoV-2 Antibody in Patients With Moderate-to-Severe COVID-19. Clin Ther. 2026 Mar;48(3):232-239. doi: 10.1016/j.clinthera.2026.01.004. Epub 2026 Feb 7. | |
| 34473343 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo | Drug | Administered intravenously (IV) single dose |
|
| through Day 28 |
| Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of COR-101 | through Day 60 |
| Assessment of PK parameter: Time to Cmax (tmax) for COR-101 | through Day 60 |
| Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101 | through Day 60 |
| Assessment of PK parameter: Clearance (CL) for COR-101 | through Day 60 |
| Assessment of PK parameter: Mean residence time (MRT) of COR-101 | through Day 60 |
| Secondary PD endpoint: Change of the viral load of SARS-CoV-2 from baseline, as measured from nasopharyngeal swab samples by qRT-PCR | through Day 21 |
| Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to COR-101 | through Day 60 |
| Derived |
| Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |