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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-13

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Convalescent Plasma

200 ml of convalescent plasma, single dose.

Group Type EXPERIMENTAL

Convalescent plasma

Intervention Type BIOLOGICAL

Convalescent plasma obtained by aphaeresis from recovered patients.

Interventions

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Convalescent plasma

Convalescent plasma obtained by aphaeresis from recovered patients.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No