Using convalescent plasma to treat COVID-19 in adults and children
Convalescent Plasma Collection From Individuals That Recovered From COVID19 and Treatment of Critically Ill Individuals With Donor Convalescent Plasma
This study is testing whether giving convalescent plasma from people who have recovered from COVID-19 can help treat adults and children currently infected with the virus.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 31 Days and up |
| Sex | All |
| Sponsor | West Virginia University Academic / other |
| Drugs / interventions | Tocilizumab |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT04376034 on ClinicalTrials.gov |
What this trial studies
This study aims to collect and utilize convalescent plasma from individuals who have recovered from COVID-19 to treat patients currently suffering from the virus. Participants will be categorized into three severity groups: mild, moderate, and severe/critical, with varying amounts of plasma administered based on their condition. The study will involve up to 240 patients receiving plasma and up to 1000 potential donors, following FDA guidelines for plasma collection and treatment. The approach leverages the antibodies present in the plasma to enhance the immune response against the virus.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with COVID-19 who are experiencing mild to severe symptoms.
Not a fit: Patients who are currently asymptomatic or have not been diagnosed with COVID-19 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with COVID-19, potentially improving recovery outcomes.
How similar studies have performed: Other studies have shown promise in using convalescent plasma for treating viral infections, including COVID-19, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Plasma donation:
1. Prior diagnosis of COVID-19 documented by a laboratory test
1. Abbott RealTime SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) test on the Abbott m2000 System (Inpatient WVU testing)
2. Other testing methods and vendors using FDA approved detection methods of SARS-CoV-2 under the Emergency Use Authorization (EUA)
2. Complete resolution of symptoms at least 28 days prior to donation
3. Complete resolution of symptoms for at least 14 days with negative repeat COVID-19 testing approved by the FDA EUA
4. Female donors age 18+ that have never been pregnant or negative for HLA antibodies
5. Male donors age 18+
6. Negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from blood. A partial list of available tests can be accessed at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
7. Defined SARS-CoV-2 neutralizing antibody titers, if testing can be conducted (e.g., of at least 1:1602, 1:360 up to 1:640 is preferred. In shortage case 1:80 is acceptable)
8. At least or greater than 50kg of weight
* Plasma Recipients:
1. Individuals of any age above 30 days of life, sex, or pregnancy status suffering from confirmed COVID19 and in rapid progression, severe or critical condition meeting the FDA IND guidelines.
2. Must have laboratory confirmed COVID19
3. Must have severe or immediately life-threatening COVID19
4. Must provide informed consent/assent
Exclusion Criteria:
* Plasma donation:
1. Individuals that do not meet the requirement from the American Red Cross for plasma donation or equivalent
2. Individuals plasma that has not passed safety screening after procurement by the American Red Cross for plasma donation or equivalent
* Plasma Recipients
1. Individuals with COVID19 who are not in clinical concern for rapid progression, severe or critical condition
2. Individuals who are in critical condition that are not confirmed to have COVID19
3. Individuals with known Selective IgA Deficiency, that has not been found to be absent of anti-IgA antibodies
Where this trial is running
Morgantown, West Virginia
- WVU Medicine — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Brian Peppers, DO, PhD — WVU Medicine Children's
- Study coordinator: Brian Peppers, DO, PhD
- Email: brian.peppers@hsc.wvu.edu
- Phone: 304-594-2483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.