View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
April 1, 2021updated 12 Jul 2022 11:21am

Kamada’s IgG treatment aids patient recovery in Covid-19 trial

Kamada has reported top-line results from its Phase I/II clinical trial of anti-SARS-CoV-2 plasma-derived hyperimmune globulin (IgG) treating hospitalised Covid-19 patients in Israel.

Kamada has reported top-line results from its Phase I/II clinical trial of anti-SARS-CoV-2 plasma-derived hyperimmune globulin (IgG) for treating hospitalised Covid-19 patients in Israel.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

Conducted as part of the company’s global partnership with Kedrion Biopharma, the trial evaluated the safety, anti-SARS-CoV-2 IgG levels, virus neutralisation activity and other exploratory efficacy outcomes in hospitalised, non-ventilated Covid-19 patients with pneumonia.

The open-label, single-arm, multi-centre trial enrolled 12 eligible subjected aged 34-69. They received 4g dose of Kamada’s product within three to ten days of symptom onset.

The participants were followed up for 84 days after the treatment.

In September last year, Kamada had reported interim data results from the study.

Results showed that 11 out of the 12 subjects recovered on receiving the treatment while seven were discharged from the hospital at or before day five post-treatment. The remaining four subjects were discharged by day nine.

In addition, anti-SARS CoV-2 IgG levels in the plasma of all patients improved on administering the product.

The IgG product showed a favourable safety profile and no infusion-related reactions or adverse events related to the study drug were observed.

In January this year, the Israeli Ministry of Health commenced a multi-centre clinical study of Kamada’s Covid-19 IgG product.

Currently, the trial has enrolled over 100 hospitalised patients with moderate to severe Covid-19. They randomly received either 4g IgG product or two units of convalescent plasma and will be followed up for 14 days.

Kamada CEO Amir London said: “We believe the top-line results of our Phase I/II study are indicative of the potential of our plasma-derived IgG product to be a safe and effective treatment for hospitalised Covid-19 patients.

“Along with our partner, Kedrion Biopharma, we will evaluate the results of the ongoing multicentre clinical study being conducted by the IMOH, which are expected later in 2021, in order to determine the next steps with respect to our Covid-19 IgG clinical development programme.”

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena