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Ruconest · 1 trial · 1 indication
The disease severity on the 7-point WHO Ordinal Scale on Day 7 was the primary objective of this study. This endpoint had been suggested by the WHO for clinical trials in patients with Covid-19. The ordinal scale measures illness severity over time. The higher score, the worst outcome: meaning score 1, no limitation in activities and score 7, death.
| Arm | Type | Description |
|---|---|---|
| Ruconest | EXPERIMENTAL | Patients receive (150 U/ml) of Ruconest at a 50 U/kg dose (max dose of 4200 U) as a slow intravenous injection via a peripheral every 12 hours; for 4 days. A total of 8 doses will be administered. |
| Standard of Care | OTHER | SOC |
| Name | Type | Description |
|---|---|---|
| Ruconest | DRUG | Patients will be randomized to Ruconest or Standard of Care |
Inclusion Criteria: * Age 18-85 years, * Admitted to the hospital because of confirmed positive SARS-CoV-2 (COVID-19 infection). * Evidence of pulmonary involvement on CT scan or X-Ray of the chest, * Symptom onset within the previous 10 days AND at least one additional risk factor for progression ...
Ruconest is a small molecule being studied for use in confirmed Coronavirus Disease, specifically for the prevention of severe SARS-CoV-2 infection in hospitalized patients with COVID-19. It is an investigational drug and is not approved for this indication.
Ruconest targets the complement system, specifically the C1 esterase inhibitor. It is a recombinant human C1 inhibitor that works by regulating complement activation, which may help prevent severe inflammation and tissue damage in COVID-19 patients.
Ruconest is developed by Pharming Group N.V., a biopharmaceutical company. The company's stock is traded under the ticker PHAR. Pharming is conducting clinical trials to evaluate Ruconest for the treatment of confirmed Coronavirus Disease.
Ruconest is in Phase 2 clinical development for the prevention of severe SARS-CoV-2 infection in hospitalized patients with COVID-19. The Phase 2 trial has been completed, and the drug remains investigational for this use.
Ruconest has been studied in one clinical trial, NCT04530136, titled 'Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19'. This Phase 2 trial was completed in the United States and enrolled 38 patients aged 18 years and older.
Ruconest is a recombinant human C1 esterase inhibitor, which is distinct from plasma-derived C1 inhibitors. It is specifically developed by Pharming Group N.V. and is being investigated for COVID-19, whereas other C1 inhibitors may be approved for different indications.