The plan is to commence the trial immediately at around ten US research sites. Credit: cromaconceptovisual from Pixabay.

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.

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“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.