COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Centro de Hematología y Medicina Interna
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Overall survival
- Last Updated
- 6 years ago
Overview
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.
Investigators
Guillermo J. RUIZ-ARGÜELLES
Dr. Guillermo J. Ruiz-Argüelles
Centro de Hematología y Medicina Interna
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Overall survival
Time Frame: 15-30 days
Patients survival after therapy
Lung injury
Time Frame: 7 days
PaO2/FiO2 relation
Secondary Outcomes
- Adverse reactions to plasma(7 days)