NCT04357106

Brief Summary

COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 14, 2020

Last Update Submit

April 21, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

  • Lung injury

    PaO2/FiO2 relation

    7 days

  • Overall survival

    Patients survival after therapy

    15-30 days

Secondary Outcomes (1)

  • Adverse reactions to plasma

    7 days

Study Arms (1)

Convalescent Plasma

EXPERIMENTAL

200 ml of convalescent plasma, single dose.

Biological: Convalescent plasma

Interventions

Convalescent plasmaBIOLOGICAL

Convalescent plasma obtained by aphaeresis from recovered patients.

Convalescent Plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with SARS-CoV2 infection who have had a serious evolution and are in an ICU
  • With or without ventilatory assistance
  • Treated or not with hydroxychloroquine 200 mg. every 12 hours
  • Indistinct sex
  • Older than 18 years
  • Signed informed consent

You may not qualify if:

  • Patients treated with the following medications: azithromycin, ritonavir / lopinavir, remdesivir, interferons, ruxolinitib, tocilizumab.
  • Patients with severe kidney failure who require replacement therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Hematología y Medicina Interna

Puebla City, 72530, Mexico

RECRUITING

Related Publications (4)

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

    PMID: 37162745DERIVED

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

    PMID: 36734509DERIVED

  • Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

    PMID: 34013969DERIVED

  • Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.

    PMID: 33044747DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Juan Carlos Olivares-Gazca, MD, MPH

CONTACT

2222438100jolivares@hsctmexico.com

José Manuel Priesca-Marin, MD

CONTACT

2222438100mpriesca@hsctmexico.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Guillermo J. Ruiz-Argüelles

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 22, 2020

Study Start

April 13, 2020

Primary Completion

July 1, 2020

Study Completion

August 1, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)