NCT04384588: FALP-COVID

COVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (FALP-COVID)

Status unknown Phase 2, PHASE3 Last updated 12 May 2020

What this trial tests

Phase 2, PHASE3 trial testing Convalescent Plasma from COVID-19 donors in COVID-19 Infection in 100 participants. Status unknown.

Timeline

7 April 2020

Primary endpoint
6 April 2021

6 April 2021

Quick facts

Lead sponsor	Fundacion Arturo Lopez Perez
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	7 April 2020
Primary completion	6 April 2021
Estimated completion	6 April 2021
Sites	1 location across Chile

Drugs / interventions tested

• Convalescent Plasma from COVID-19 donors — full drug profile →

Conditions studied

• COVID-19 Infection — all drugs for COVID-19 Infection →
• Cancer Patients — all drugs for Cancer Patients →
• General Population — all drugs for General Population →

Sponsor

Fundacion Arturo Lopez Perez — full company profile →

Who can join

15 and older, any sex, with COVID-19 Infection or Cancer Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

COVID-19 infection has spread worldwide causing several deaths in few months Convalescent Plasma from COVID 19 donors has shown huge activity in small series from Chinese patients and currently many centers from USA and the European Union are assessing its use looking to avoid mortality and prolonged hospitalizations COVID-19-related

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. Cancer Management during COVID-19 Pandemic: Is Immune Checkpoint Inhibitors-Based Immunotherapy Harmful or Beneficial?
   Vivarelli S, Falzone L, Grillo CM, Scandurra G, et al · · 2020 · cited 63× · PMID 32785162 · DOI 10.3390/cancers12082237
5. Insights into neutralizing antibody responses in individuals exposed to SARS-CoV-2 in Chile.
   Beltrán-Pavez C, Riquelme-Barrios S, Oyarzún-Arrau A, Gaete-Argel A, et al · · 2021 · cited 29× · PMID 33579701 · DOI 10.1126/sciadv.abe6855
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. Humoral immune mechanisms involved in protective and pathological immunity during COVID-19.
   Widjaja G, Turki Jalil A, Sulaiman Rahman H, Abdelbasset WK, et al · · 2021 · cited 24× · PMID 34229864 · DOI 10.1016/j.humimm.2021.06.011