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

COVID-19 Clinical Trial

— COPLA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04357106
• Other study ID #: CHMI-030420-01
• Status: Recruiting
• Phase: Phase 2
• Start date: April 13, 2020
• Est. completion date: August 2020

Study information

• Verified date: April 2020
• Source: Centro de Hematología y Medicina Interna
• Contact: Juan Carlos Olivares-Gazca, MD, MPH
• Phone: 2222438100
• Email: jolivares[@]hsctmexico.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Severe Acute Respiratory Syndrome

Intervention

Biological:
• Convalescent plasma
Convalescent plasma obtained by aphaeresis from recovered patients.

Locations

Country	Name	City	State
Mexico	Centro de Hematología y Medicina Interna	Puebla

Sponsors (2)

Lead Sponsor	Collaborator
Centro de Hematología y Medicina Interna	Laboratorios Clínicos de Puebla (Laboratorios Ruiz)

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung injury	PaO2/FiO2 relation	7 days
Primary	Overall survival	Patients survival after therapy	15-30 days
Secondary	Adverse reactions to plasma	Determine the incidence of side effects from plasma administration	7 days