The first patient has been enrolled in a randomised, open label, parallel group, controlled, pilot clinical trial in up to 120 patients hospitalized with confirmed COVID-19 treated with Ruconest (recombinant human C1 inhibitor) for the prevention of severe SARS-CoV-2 infections at the Valley Hospital in Ridgewood, New Jersey in the United States.
Initially based at Valley Hospital in Ridgewood, New Jersey, this trial is planned to include patients at multiple centres in the US. This clinical trial follows an ongoing investigator-initiated, multinational, multicentre study, led by Dr. Michael Osthoff from the University Hospital Basel, into the use of Ruconest in the prevention of severe SARS-CoV-2 infections in patients hospitalised with related severe pneumonia. Pharming Group N.V. announced the enrolment of the first patient in that trial in August 2020.
Systemic hyperinflammation is a hallmark of more severe stages of COVID-19 leading to acute respiratory distress syndrome, mechanical ventilation and ultimately death. Treatment with Ruconest may; 1) dampen uncontrolled complement activation and collateral lung damage; 2) reduce capillary leakage and subsequent pulmonary edema by direct inhibition of the kallikrein-kinin system; and 3) reduce the generation of microthrombi by inhibiting MASP-1 induced clot formation and factor XII amplified thrombo-inflammation.
C1 inhibitor is an acute phase reactant, meaning that the body naturally increases production during inflammatory conditions, such as infections. Despite this, a relative deficiency may occur and complement activation continues unchecked, often leading to a cytokine storm, a dangerous biochemical process that worsens the complications of COVID-19 infection, such as organ failure and death.
These clinical studies in hospitalized patients with confirmed COVID-19 seek to identify if the administration of additional C1INH can control or stop the systemic hyperinflammation syndrome or cytokine storm. Headline data will be made publicly available following either an interim analysis or after all patients have been treated.
(Source: Pharming)
