Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rNAPc2 · 2 trials · 2 indications
Proportional change is represented as percent change, and is defined as: 100 × (D-Dimer level at Day 8 or early discharge - D-Dimer level at baseline) / D-Dimer level at baseline. Baseline and post-baseline D-Dimer results are tested in the same laboratory, i.e. both from central laboratory, or local laboratory paired samples if the central laboratory values are not available.
| Arm | Type | Description |
|---|---|---|
| rNAPc2 Higher Dose | EXPERIMENTAL | loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5 |
| rNAPc2 Lower Dose | EXPERIMENTAL | loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5 |
| Heparin | ACTIVE_COMPARATOR | heparin at either prophylactic or therapeutic doses per Standard of Care at Institution |
| Name | Type | Description |
|---|---|---|
| rNAPc2 | DRUG | two dose levels of rNAPc2 |
| Heparin | DRUG | standard of care heparin per institution (therapeutic or prophylactic regimen) |
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 90 years at the Screening assessment 2. Weight ≥ 50 kg at randomization 3. Hospitalized with a diagnosis of COVID-19 and in need of inpatient medical care 4. Positive for SARS-CoV-2 on nasopharyngeal, oropharyngeal or other tissue/body fluid samples by PC...
rNAPc2 is an investigational small molecule being studied for coronary disease and COVID-19. In coronary disease, it was evaluated in a Phase 2 trial to eliminate major adverse cardiac events. In COVID-19, a separate Phase 2 trial assessed its safety, hospitalization rates, and efficacy. Both trials are completed.
rNAPc2 is a small molecule that targets the coagulation pathway. It is being developed as an anticoagulant to reduce thrombotic events in conditions like coronary disease and COVID-19. The specific molecular target is not disclosed in the available information.
rNAPc2 is being developed by Oruka Therapeutics, Inc., a biopharmaceutical company traded under the ticker ORKA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in coronary disease and COVID-19.
rNAPc2 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in coronary disease and one in COVID-19. The drug is investigational and has not been approved by regulatory authorities.
rNAPc2 has completed two Phase 2 trials. NCT00116012, titled 'Anticoagulation With rNAPc2 to Eliminate MACE/TIMI 32,' enrolled 300 participants with coronary disease in the United States. NCT04655586, titled 'Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19,' enrolled 160 participants in the United States, Argentina, and Brazil.
No alternative names for rNAPc2 have been reported. The drug is identified solely by its code name rNAPc2 in clinical trial registrations and development programs.