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Virus Therapy

Convalescent Plasma for Coronavirus

Phase 1
Waitlist Available
Led By Jaime G Deville, M.D.
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 1 month and < 18 years at the time of consent
For females of reproductive potential (defined as having experienced menarche), not pregnant based on testing performed at screening
Must not have
For females, breastfeeding, or planning to become pregnant/breastfeed during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 7, 14, and 28
Awards & highlights
No Placebo-Only Group

Summary

This trial will provide convalescent plasma to pediatric patients with underlying conditions who have either been infected with SARS-CoV-2 or been exposed to it. The plasma comes from people who have recovered from the infection. The trial will collect data on the safety and how well the plasma works.

Who is the study for?
This trial is for children under 18 with conditions like heart or lung disease, or weakened immune systems. It's also for those who've been exposed to COVID-19 or tested positive within the past few days. Girls must not be pregnant and all participants need a guardian's consent.
What is being tested?
The study tests convalescent plasma from recovered COVID-19 patients as a treatment and preventive measure in kids at high risk of severe illness. They'll receive one transfusion and will be monitored for safety and how their body processes it.
What are the potential side effects?
Potential side effects include allergic reactions similar to other blood product transfusions, such as fever, itching, chills; however, these are typically mild and manageable with pre-medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 18 years old.
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I am not pregnant, as confirmed by a test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, or planning to during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 7, 14, and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 7, 14, and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative incidence of Grade 3 and Grade 4 adverse events
Cumulative incidence of serious adverse events
Secondary study objectives
Percentage of participants with a natural antibody response to SARS-CoV-2 infection
Proportion of participants with disease worsening event.
Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: anti-SARS-CoV-2 human convalescent plasmaExperimental Treatment1 Intervention
single transfusion of human convalescent plasma

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,564 Previous Clinical Trials
10,262,603 Total Patients Enrolled
Jaime G Deville, M.D.Principal InvestigatorUCLA Clinical Professor of Pediatrics

Media Library

anti-SARS-CoV-2 human convalescent plasma (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04462848 — Phase 1
Coronavirus Research Study Groups: anti-SARS-CoV-2 human convalescent plasma
Coronavirus Clinical Trial 2023: anti-SARS-CoV-2 human convalescent plasma Highlights & Side Effects. Trial Name: NCT04462848 — Phase 1
anti-SARS-CoV-2 human convalescent plasma (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04462848 — Phase 1
~6 spots leftby Nov 2025
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