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COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma

COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04357106
Acronym
COPLA
Enrollment
10
Registered
2020-04-22
Start date
2020-04-13
Completion date
2020-08-31
Last updated
2020-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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.

Interventions

BIOLOGICALConvalescent plasma

Convalescent plasma obtained by aphaeresis from recovered patients.

Sponsors

Laboratorios Clínicos de Puebla (Laboratorios Ruiz)
CollaboratorUNKNOWN
Centro de Hematología y Medicina Interna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Lung injury7 daysPaO2/FiO2 relation
Overall survival15-30 daysPatients survival after therapy

Secondary

MeasureTime frameDescription
Adverse reactions to plasma7 daysDetermine the incidence of side effects from plasma administration

Countries

Mexico

Contacts

Primary ContactJuan Carlos Olivares-Gazca, MD, MPH
jolivares@hsctmexico.com2222438100
Backup ContactJosé Manuel Priesca-Marin, MD
mpriesca@hsctmexico.com2222438100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026