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

Phase 2

• Conditions: COVID-19
• Interventions: Biological: Convalescent plasma

• Registration Number: NCT04357106
• Lead Sponsor: Centro de Hematología y Medicina Interna

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-13
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22
• Primary Completion: 2020-07
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Convalescent Plasma	Convalescent plasma	200 ml of convalescent plasma, single dose.

Primary Outcome Measures

Name	Time	Method
Lung injury	7 days	PaO2/FiO2 relation
Overall survival	15-30 days	Patients survival after therapy

Secondary Outcome Measures

Name	Time	Method
Adverse reactions to plasma	7 days	Determine the incidence of side effects from plasma administration

Trial Locations

Locations (1)

Centro de Hematología y Medicina Interna; 🇲🇽 Puebla, Mexico