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

C

Centro de Hematología y Medicina Interna

Status and phase

Unknown
Phase 2

Conditions

COVID-19

Treatments

Biological: Convalescent plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT04357106
CHMI-030420-01

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Convalescent Plasma
Experimental group
Description:
200 ml of convalescent plasma, single dose.
Treatment:
Biological: Convalescent plasma

Trial contacts and locations

1

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Central trial contact

Juan Carlos Olivares-Gazca, MD, MPH; José Manuel Priesca-Marin, MD

Data sourced from clinicaltrials.gov

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