Octapharma USA has secured regulatory approval to conduct a Phase III clinical trial of Octagam 10% for the potential treatment of Covid-19 patients with severe disease progression.
Octagam 10% is an immune globulin intravenous (human) liquid preparation intended to treat adults with chronic immune thrombocytopenic purpura (ITP).
The randomised, double-blind, placebo-controlled, multi-centre trial will assess the safety and efficacy of the drug. The primary objective is to investigate the ability of a high-dose of Octagam 10% to slow or stop respiratory deterioration.
The trial’s secondary objectives are the effects of a high-dose of the drug on slowing or halting Covid-19 clinical progression by improving pulmonary function, quality of life, and correlated impact on metabolic factors.
Octapharma USA president Flemming Nielsen said: “Intravenous immunoglobulin (IVIG), which consists of pooled IgG preparations from thousands of donors, has been used to treat patients with immune-mediated diseases for almost 40 years.
“Our hypothesis is that the use of IVIG in the prophylaxis of severe infections, especially in immunocompromised patients, makes it an attractive therapeutic possibility for Covid-19.”
The plan is to commence the trial immediately at around ten US research sites. The aim is to recruit approximately 54 adults with Covid-19 and a resting SpO2 of ≤93% who need oxygen supplementation.
Participants will be given Octagam 10% or a placebo and will be tracked for around 33 days. Patients on the drug candidate will receive a total dose of 2g/kg as an intravenous infusion of 0.5g/kg daily for four consecutive days.
Octapharma Research & Development head Wolfgang Frenzel said: “The effects of the immune-modulating properties of IVIG in severely-ill Covid-19 patients appeared to be demonstrated in the case reports and we are, therefore, hopeful that we will observe improved clinical status in the patients receiving Octagam 10%.”
Data from the trial is expected to be reported by the third quarter of this year.