NCT04365439

Convalescent Plasma for COVID-19

Status unknown NA Last updated 29 March 2021

What this trial tests

NA trial testing Blood plasma in Blood Plasma Therapy in 11 participants. Status unknown.

Timeline

20 July 2020

Primary endpoint
20 December 2020

30 June 2021

Quick facts

Lead sponsor	Enos Bernasconi
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	20 July 2020
Primary completion	20 December 2020
Estimated completion	30 June 2021
Sites	1 location across Switzerland

Drugs / interventions tested

• Blood plasma — full drug profile →

Conditions studied

• Blood Plasma Therapy — all drugs for Blood Plasma Therapy →
• COVID — all drugs for COVID →

Sponsor

Enos Bernasconi — full company profile →

Who can join

Adults 18 to 75, any sex, with Blood Plasma Therapy or COVID. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this proof of concept study is to provide COVID-19 convalescent plasma to patients with moderate to severe COVID-19 and assess:

* the titer of anti-COVID-19 antibodies in the donors and in the patients before and after treatment;
* the in-depth analysis of immunological parameters in the donors and in recipient before and after treatment;
* the impact of plasma transfusion on the reduction of viral load and inflammation
* safety and tolerability
* clinical efficacy

Publications & conference data

8 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, Chai KL, Valk SJ, Doree C, et al · · 2020 · cited 148× · PMID 32648959 · DOI 10.1002/14651858.cd013600.pub2
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. Convalescent plasma therapy for COVID-19 patients: a protocol of a prospective meta-analysis of randomized controlled trials.
   Szakó L, Farkas N, Kiss S, Váncsa S, et al · · 2021 · cited 2× · PMID 33522939 · DOI 10.1186/s13063-021-05066-2