NCT04649879

Convalescent Plasma for Treatment of COVID-19

Completed Phase 2, PHASE3 Last updated 9 February 2022

What this trial tests

Phase 2, PHASE3 trial testing SARS-CoV-2 convalescent plasma in Covid19 in 59 participants. Completed in 26 January 2022.

Timeline

3 December 2020

Primary endpoint
26 January 2022

26 January 2022

Quick facts

Lead sponsor	Joakim Dillner
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	3 December 2020
Primary completion	26 January 2022
Estimated completion	26 January 2022
Sites	3 locations across Sweden

Drugs / interventions tested

• SARS-CoV-2 convalescent plasma — full drug profile →
• Standard of care

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Joakim Dillner — full company profile →

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicate that it is safe for treatment of COVID-19. We found that viremia upon admission identifies patients at 7 fold increased risk of admission to intensive care and 8 fold increased risk of death. CP treatment appeared to result in rapid viral clearance in a small case series. CP appeared to be well tolerated in a phase I study in which patients only received one dose of CP and a phase II study in which CP was given until viremia disappeared (unpublished data).

Randomised controlled studies assessing the efficacy of CP are lacking and thus the efficacy of CP is unknown. Preliminary data indicate that treatment should be given early, prior to development of severe illness. Detection of viremia upon admission identifies a group at high risk of severe disease and death that has the most to benefit from CP. Phase II study data indicates that treatment should be given until SARS-CoV-2 is no longer detected in serum and the donor antibody neutralization titres should be ≥1/640. A randomised controlled trial in which viremic patients are treated with CP with the equivalent of an antibody titre ≥1/640 is thus required to determine if CP can be an effective COVID-19 treatment.

Publications & conference data

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

1. 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
2. COVID-19 convalescent plasma: Interim recommendations from the AABB.
   Cohn CS, Estcourt L, Grossman BJ, Pagano MB, et al · · 2021 · cited 38× · PMID 33586160 · DOI 10.1111/trf.16328
3. An updated overview of recent advances, challenges, and clinical considerations of IL-6 signaling blockade in severe coronavirus disease 2019 (COVID-19).
   Elahi R, Karami P, Heidary AH, Esmaeilzadeh A. · · 2022 · cited 33× · PMID 35074571 · DOI 10.1016/j.intimp.2022.108536
4. 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
5. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 21× · PMID 37162745 · DOI 10.1002/14651858.cd013600.pub6
6. Human Identical Sequences, hyaluronan, and hymecromone ─ the new mechanism and management of COVID-19.
   Yang S, Tong Y, Chen L, Yu W. · · 2022 · cited 4× · PMID 35593963 · DOI 10.1186/s43556-022-00077-0
7. Convalescent plasma for treatment of COVID-19: study protocol for an open randomised controlled trial in Sweden.
   Dillner J, Ursing J. · · 2021 · cited 2× · PMID 34880010 · DOI 10.1136/bmjopen-2020-048337