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Convalescent Plasma for COVID-19

Phase 2

Waitlist Available

Led By Michele L Donato, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to treatment, 2 weeks, 4 weeks, and 2 months

Awards & highlights

Study Summary

This trial is testing whether convalescent plasma can help treat people with COVID-19 who are at high risk for complications.

Eligible Conditions

COVID-19
Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to treatment, 2 weeks, 4 weeks, and 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to treatment, 2 weeks, 4 weeks, and 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to treatment, 2 weeks, 4 weeks, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hospitalization Rate

Secondary outcome measures

Impact of Donor Titers Level on Efficacy

Overall Survival Rate

Patients' Anti-SARS-CoV2 Titer Assessment Pre-infusion for the Treatment Group, at 2 Weeks , 4 Weeks and 2 Months.

+5 more

Other outcome measures

Patients' Chemokines Levels Assessment at +2 and +4 Weeks Post Randomization

Patients' Cytokines Levels Assessment at +2 and +4 Weeks Post Randomization

Plasma Product's Annexin V Level Assessment

+9 more

Side effects data

From 2021 Phase 3 trial • 511 Patients • NCT04355767

12%

Pneumonia

Infusion related reaction

Dyspnea

Hypoxia

Fatigue

Pulmonary embolism

Chest pain

Flank pain

Migraine

Dehydration

Acute respiratory failure

Vomiting

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Convalescent Plasma

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Convalescent PlasmaExperimental Treatment1 Intervention

Fresh or frozen plasma will be infused one time to patients

Group II: Best Supportive CareActive Control1 Intervention

Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Convalescent Plasma

2020

Completed Phase 3

~4590

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor

131 Previous Clinical Trials

28,223 Total Patients Enrolled

7 Trials studying COVID-19

4,643 Patients Enrolled for COVID-19

United States Department of DefenseFED

859 Previous Clinical Trials

225,477 Total Patients Enrolled

19 Trials studying COVID-19

6,954 Patients Enrolled for COVID-19

Michele L Donato, MDPrincipal InvestigatorHackensack Meridian Health

1 Previous Clinical Trials

52 Total Patients Enrolled

1 Trials studying COVID-19

52 Patients Enrolled for COVID-19

Frequently Asked Questions

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

What precautions should be taken when administering Convalescent Plasma to patients?

"While there exists some evidence of Convalescent Plasma's security, the lack of data supporting efficacy warrants a score of 2 on Power's scale."

Answered by AI

How many subjects are being monitored for this experiment?

"This research project is no longer seeking participants. The trial, first posted on November 6th 2020 and last updated June 28th 2022 has concluded its recruitment period. Alternately, there are 1717 clinical trials recruiting patients with Covid-19 and 4 Convalescent Plasma studies actively accepting enrollees."

Answered by AI

Could you please elucidate other investigations involving Convalescent Plasma?

"At present, 4 studies are researching the use of Convalescent Plasma. None of these active experiments have reached Phase 3 yet. While most trials for this treatment occur in Bonheiden, Brabant Wallon there are 21 other sites involved as well."

Answered by AI

Does this investigation have room for additional participants?

"Contrary to what was initially thought, clinicaltrials.gov displays that this trial is no longer recruiting patients; the first post was made on November 6th 2020 and the last update occurred 28 June 2022. Despite its closure, there remain 1,721 other trials across the globe actively seeking volunteers at present."

Answered by AI

Recent research and studies

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

Nature Reviews MicrobiologyJournal

Passive Antibody Therapy for Infectious Diseases

Casadevall, Arturo, Ekaterina Dadachova, and Liise-anne Pirofski. 2004. “Passive Antibody Therapy for Infectious Diseases”. Nature Reviews Microbiology. Springer Science and Business Media LLC. doi:10.1038/nrmicro974.

Journal of InfectionJournal

Evaluation of Convalescent Whole Blood for Treating Ebola Virus Disease in Freetown, Sierra Leone

Sahr, F., R. Ansumana, T.A. Massaquoi, B.R. Idriss, F.R. Sesay, J.M. Lamin, S. Baker, et al.. 2017. “Evaluation of Convalescent Whole Blood for Treating Ebola Virus Disease in Freetown, Sierra Leone”. Journal of Infection. Elsevier BV. doi:10.1016/j.jinf.2016.11.009.

Pharmaceutical StatisticsJournal