NCT04385186

Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19

Status unknown Phase 2 Last updated 2 June 2020

What this trial tests

Phase 2 trial testing Inactivated convalescent plasma in Infections, Coronavirus in 60 participants. Status unknown.

Timeline

20 June 2020

Primary endpoint
30 November 2020

30 December 2020

Quick facts

Lead sponsor	National Blood Center Foundation, Hemolife
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	20 June 2020
Primary completion	30 November 2020
Estimated completion	30 December 2020
Sites	10 locations across Colombia

Drugs / interventions tested

• Inactivated convalescent plasma — full drug profile →
• Support treatment — full drug profile →

Conditions studied

• Infections, Coronavirus — all drugs for Infections, Coronavirus →

Sponsor

National Blood Center Foundation, Hemolife

Who can join

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

Sponsor's own description

Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.

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. Treatment of COVID-19 with convalescent plasma: lessons from past coronavirus outbreaks.
   Wooding DJ, Bach H. · · 2020 · cited 55× · PMID 32791241 · DOI 10.1016/j.cmi.2020.08.005
4. Immune reactivity during COVID-19: Implications for treatment.
   Napoli C, Benincasa G, Criscuolo C, Faenza M, et al · · 2021 · cited 40× · PMID 33421440 · DOI 10.1016/j.imlet.2021.01.001
5. 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
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. 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
8. 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