NCT04462848

Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions

Phase I Study of the Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.

Conditions

• Corona Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	anti-SARS-CoV-2 human convalescent plasma	Single transfusion. The total volume (mL) to be transfused will be based on participant weight (kg) and will be calculated as 5 mL/kg. The maximum volume to be transfused will be 500 mL.

Timeline

• Start date: 2020-08-01
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2020-07-08
• Last updated: 2020-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study