NCT04376034

Convalescent Plasma Collection and Treatment in Pediatrics and Adults

Recruiting now Phase 3 Last updated 6 May 2020

What this trial tests

Phase 3 trial testing Convalescent Plasma 1 Unit in COVID19 in 240 participants. Currently enrolling.

Timeline

16 April 2020

Primary endpoint
30 March 2021

30 March 2021

Quick facts

Lead sponsor	West Virginia University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	16 April 2020
Primary completion	30 March 2021
Estimated completion	30 March 2021
Sites	1 location across United States

Drugs / interventions tested

• Convalescent Plasma 1 Unit — full drug profile →
• Convalescent Plasma 2 Units — full drug profile →
• Standard of Care

Conditions studied

• COVID19 — all drugs for COVID19 →
• Coronavirus Infection — all drugs for Coronavirus Infection →
• Coronavirus — all drugs for Coronavirus →
• Virus Diseases — all drugs for Virus Diseases →

Sponsor

West Virginia University

Who can join

31 Days and older, any sex, with COVID19 or Coronavirus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors.

There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
2. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
   Piechotta V, Chai KL, Valk SJ, Doree C, et al · · 2020 · cited 148× · PMID 32648959 · DOI 10.1002/14651858.cd013600.pub2
3. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
   Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4
4. Convalescent Plasma Therapy for COVID-19: State of the Art.
   Focosi D, Anderson AO, Tang JW, Tuccori M. · · 2020 · cited 88× · PMID 32792417 · DOI 10.1128/cmr.00072-20
5. COVID-19 Convalescent Plasma and Clinical Trials: Understanding Conflicting Outcomes.
   Focosi D, Franchini M, Pirofski LA, Burnouf T, et al · · 2022 · cited 79× · PMID 35262370 · DOI 10.1128/cmr.00200-21
6. Cancer, immune suppression and Coronavirus Disease-19 (COVID-19): Need to manage drug safety (French Society for Oncology Pharmacy [SFPO] guidelines).
   Slimano F, Baudouin A, Zerbit J, Toulemonde-Deldicque A, et al · · 2020 · cited 29× · PMID 32623296 · DOI 10.1016/j.ctrv.2020.102063
7. Coronavirus disease 2019 (COVID-19): Immunological approaches and emerging pharmacologic treatments.
   Goodarzi P, Mahdavi F, Mirzaei R, Hasanvand H, et al · · 2020 · cited 26× · PMID 32795893 · DOI 10.1016/j.intimp.2020.106885
8. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 24× · PMID 36734509 · DOI 10.1002/14651858.cd013600.pub5