Convalescent Plasma for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
COVID-19+5 More
Convalescent Plasma - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if convalescent plasma can help treat people hospitalized with COVID-19 infection.

Eligible Conditions
  • COVID-19
  • COVID19 (disease)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 0, 3, 10, 30, and 60 Days

Day 60
Recipient Anti-SARS-CoV2 titer assessment on days 0 (pre-infusion),3,10,30, 60
30 Days
Primary objective for patients with COVID-19 already intubated
60 Days
Duration of hospitalization
Duration of mechanical ventilation
Impact of donor titers level on efficacy
Impact of donor titers level on safety
Overall survival
Rate of virologic clearance by nasopharyngeal swab at day 10
Time to symptoms resolution
7 Days
Intubation (procedure)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Convalescent Plasma
12%Pneumonia
4%Infusion related reaction
2%Hypoxia
2%Dyspnea
1%Acute respiratory failure
1%Migraine
1%Fatigue
1%Dehydration
1%Vomiting
1%Flank pain
1%Pulmonary embolism
1%Dizziness
1%Chest pain
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT04355767) in the Convalescent Plasma ARM group. Side effects include: Pneumonia with 12%, Infusion related reaction with 4%, Hypoxia with 2%, Dyspnea with 2%, Acute respiratory failure with 1%.

Trial Design

1 Treatment Group

Convalescent Plasma
1 of 1
Experimental Treatment

52 Total Participants · 1 Treatment Group

Primary Treatment: Convalescent Plasma · No Placebo Group · Phase 2

Convalescent Plasma
Biological
Experimental Group · 1 Intervention: Convalescent Plasma · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Convalescent Plasma
2020
Completed Phase 3
~3290

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0, 3, 10, 30, and 60 days

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
110 Previous Clinical Trials
23,545 Total Patients Enrolled
7 Trials studying COVID-19
4,686 Patients Enrolled for COVID-19
Michele L Donato, MDPrincipal InvestigatorHackensack Meridian Health
1 Previous Clinical Trials
21 Total Patients Enrolled
1 Trials studying COVID-19
21 Patients Enrolled for COVID-19

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
People who are 18 years or older and have started showing symptoms of the virus within the last nine days are divided into two groups: track 2 or track 3
individuals should self-monitor for 14 days after resolution of all associated symptoms including fever.
If someone is collecting blood at the John Theurer Cancer Center, they must meet the donor eligibility criteria as set by Hackensack University Medical Center and all regulatory agencies
The donor must be tested in accordance with FDA regulations and the donation must be found suitable.
procedures is a prerequisite for safe, effective and efficient patient care
The person has been hospitalized and has moderate symptoms that require medical care due to a COVID-19 infection.
The individual has a history of a positive nasopharyngeal swab for COVID-19 or a history of positive titer test.
was detected from 9,752 nasopharyngeal swabs tested
00 The level of Covid-19 neutralizing antibody present in the blood is 1:6400 or higher.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References