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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
A household member or daycare center (same room) exposure to a person with confirmed SARS-CoV-2 OR with clinically compatible disease in areas with widespread ongoing transmission
Age ≥ 1 month and < 18 years at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 7, 14, and 28
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 have been in close contact with someone who has COVID-19.
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I am under 18 years old.
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I am not pregnant, as confirmed by a test.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative incidence of Grade 3 and Grade 4 adverse events
Cumulative incidence of serious adverse events
Secondary outcome measures
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

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
1,521 Previous Clinical Trials
10,278,906 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have researchers conducted any additional investigations using human convalescent plasma to combat SARS-CoV-2?

"Currently, there are 4 ongoing medical experiments investigating the potential of anti-SARS-CoV-2 human convalescent plasma and none have reached Phase 3. These trials mainly take place in Bonheiden, Brabant Wallon although a total of 21 locations host related studies."

Answered by AI

Has the FDA officially given its stamp of approval for anti-SARS-CoV-2 human convalescent plasma?

"Our in-house experts have assigned anti-SARS-CoV-2 human convalescent plasma a score of 1 as this is still an early stage trial, meaning there are limited data to demonstrate safety and efficacy."

Answered by AI

Does this trial have any age restrictions for participants?

"This investigation is seeking out participants aged between one month and 17 years."

Answered by AI

Are there any available appointments for this research program?

"Unfortunately, this clinical trial is currently not accepting any new patients. The original posting of the study was on August 1st 2020 and there were no updates since July 7th 2020. For those looking for alternate studies to join, 91 trials are searching for participants with virus-related illnesses while 4 other studies are utilizing anti-SARS-CoV-2 human convalescent plasma and actively admitting patients."

Answered by AI

To what capacity is this clinical trial accepting participants?

"Unfortunately, this particular study is not presently open for patient recruitment. It was originally published on August 1st 2020 and the last update to its information occurred in July of 2020. For potential participants searching for other medical studies, there are currently 91 clinical trials regarding viral diseases that are accepting candidates as well as 4 anti-SARS-CoV-2 human convalescent plasma experiments actively enrolling individuals."

Answered by AI

Is it feasible for me to join this experiment?

"To be eligible for inclusion, potential candidates must suffer from a viral illness and lie between 1 Month and 17 years of age. A total of 30 people are being accepted into the trial."

Answered by AI
~3 spots leftby Sep 2024