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Octapharma cleared to start phase 3 trial of Octagam in COVID-19

Drug may stop or slow down deterioration in seriously ill patients

clinical trial

Octapharma says it will start testing its intravenous immunoglobulin (IVIG) product Octagam in patients with COVID-19 “immediately”, after getting the go-ahead from the FDA.

The placebo-controlled phase 3 trial will be conducted in seriously-ill COVID-19 patients who are experiencing rapid progression of respiratory symptoms, to see if the drug can stop or slow down the deterioration.

IVIG – which consists of pooled immunoglobulin G antibody preparations from thousands of donors -has previously been used in the treatment of severe pneumonia caused by influenza, and is already included in US clinical guidelines on the management of people who are critically ill with COVID-19 – a group in which the risk of mortality has been estimated at up to 61%.

The Switzerland-headquartered company – a specialist in plasma-derived protein products – has been selling Octagam for many years as a treatment for patients with immunodeficiency syndromes who require replacement of antibodies to help provide protection against some infections, as well as some autoimmune diseases like immune thrombocytopenia (ITP).

Retrospective studies of case reports from Wuhan in China – the centre of the original outbreak of the new coronavirus – have suggested that high-dose treatment with IVIG could be effective in slowing down COVID-19 if given within 48 hours of admission to the intensive care unit.

The data from these observational studies suggest the benefits could include reduced need for mechanical ventilation, shorter hospital stays and early recovery, although controlled trials are needed to back up those preliminary findings.

Octapharma says respiratory deterioration will be the primary outcome measure in its phase 3 trial, with secondary endpoints including pulmonary function, quality of life, and metabolic factors. It will enrol around 54 patients who need supplemental oxygen at 10 investigation sites in the US.

The subjects will receive a total dose of 2 g/kg Octagam given as an intravenous infusion of 0.5 g/kg over a two-hour period daily for four consecutive days or a matched placebo, and will be followed up for around 33 days. Octapharma says it hopes to report study results in the third quarter.

“Although many therapies based on provisional data have been proposed for patients who suffer from COVID-19, known treatments are limited,” commented Octapharma USA’s president Flemming Nielsen.

“IVIG…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,” he added.

Cases if coronavirus are tracking up towards the 5m mark worldwide, including more than 1.5m in the US, with around 325,000 and 92,000 deaths, respectively.

Article by
Phil Taylor

21st May 2020

From: Research, Regulatory, Healthcare



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