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Source: COVID-19 Treatments  Aug 08, 2020  3 years, 8 months, 1 week, 19 hours, 13 minutes ago

COVID-19 Treatments: With No Effective Antivirals, Doubts About Antibody Therapies And Vaccines, Hope Now Turned To Intravenous Immunoglobulins

COVID-19 Treatments: With No Effective Antivirals, Doubts About Antibody Therapies And Vaccines, Hope Now Turned To Intravenous Immunoglobulins
Source: COVID-19 Treatments  Aug 08, 2020  3 years, 8 months, 1 week, 19 hours, 13 minutes ago
COVID-19 Treatments: With no proper effective antivirals against the SARS-CoV-2 to date and mounting skepticism about antibody therapies and vaccines due to conflicting research studies as to whether real long time immunity protection against the SARS-CoV-2 can be truly achieved and with issues arising from all so called discovered repurposed drugs to deal with anti-inflammatory issues and cytokine storms including issues with dexamethasone, medical researchers are now turning to exploring intravenous immunoglobins to treat seriously ill COVID-19 patients.


 
Experts are saying that Intravenous immunoglobulin (IVIG) could be a key to combating seriously ill COVID-19 patients who have been hospitalized due to complications from the disease, and Octapharma AG, a leading biotech and pharmaceutical firm aims to find out as it assesses the plasma-based treatment in a Phase III study.
 
Dr Huub Kreuwel, vice president of Scientific and Medical Affairs at Octapharma USA, told Thailand Medical News that COVID-19-related deaths are typically due to the body’s overactive immune response to the disease. The role of IVIG is not to target the virus, but to help calm that overactive immune response by decreasing multiple cytokines at one time.
 
However he stressed that the use of IVIG is more of a blanket approach than Genentech and Regeneron’s earlier attempts to calm the cytokine storm by inhibiting interleukin-6 with rheumatoid arthritis drugs.
 
Intravenous immunoglobulin or IVIG contains antibodies that are harvested from plasma provided by thousands of donors across the country. IVIG, which is injected into patients, has been used in the past to help patients fight off various infections, including Kawasaki disease, which is similar to an infection some pediatric COVID-19 patients have developed as a result of the novel coronavirus.
 
It should be noted that IVIG is different than convalescent plasma, which is a therapeutic derived from the patients who have recovered from a COVID-19 infection. The blood of those patients contains antibodies against the disease.
Significantly, dosing levels are also different. The concentration of IVIG given to patients is much higher than convalescent plasma, Dr Kreuwel said.
 
The Swiss-based Octapharma teamed with the University of California at San Diego’s Dr George Sakoulas, an associate professor in the Department of Pediatrics of the University of California San Diego School of Medicine, to assess the potential impact of IVIG in these patients in a blinded Phase III study.
 
The clinical study, which is currently enrolling, is based upon results Dr Sakoulas saw in a previous pilot study this year using IVIG with COVID-19 patients.
 
Dr Sakoulas treated an adult COVID-19 patient with several comorbidities who had been declining. Within days of being treated with IVIG, that patient turned the corner and was discharged from the hospital.
 
Subsequently he met with Octapharma and the company backed his research in a small pilot study of IVIG as a treatment for COVID-19 that was randomized, but not blinded.
 
From initial stages, Dr Sakoulas said they saw a clear difference between the patients who had been treated with IVIG. Those patients saw a reduction in hospital s tay, improvement in oxygenation and removal from mechanical ventilation, he said.
 
With proven results in hand, Octapharma approached the US FDA about a late-stage clinical study. Dr Kreuwel said Octapharma expects to assess interim results in the fall. https://covid19.octapharmausa.com/html/pdf/IVIG_for_COVID-19-White-Paper-5.5.2020.pdf
 
The biotech company hopes to enroll the number of patients necessary by September or October and within a few weeks of dosing, Octapharma should be able to analyze the data to determine the efficacy and safety of the treatment.
 
Dr Sakoulas likened the use of IVIG against COVID-19 as fighting an arsonist who has started a wildfire.
 
He said, “Everyone keeps going after the virus with an antiviral. That is like trying to catch the arsonist in order to put out the fire. This (IVIG) is dampening the ground in order to fight that fire.”
 
In mid last year there was concern about a supply shortage of intravenous immunoglobulin in the United States, but Dr Kreuwel said over the past few years, Octapharma has boosted its IVIG manufacturing capabilities to support its therapeutic treatment programs in autoimmune diseases.
 
He further added, “We believe we have more than a sufficient amount to cover those needs and COVID as well.”
 
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