Convalescent Plasma for the Treatment of Severe SARS-CoV-2 (COVID-19)

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Convalescent plasma has been used for over 100 years in the treatment of severe acute respiratory infections of viral origin. There are not pharmacological treatments for the actual outbreak for SARS-Cov-2 and it is necessary to evaluate the efficacy of treatment options, including convalescent plasma transfusion. The hypothesis is that convalescent plasma is efficacious and safe for reducing mortality in patients with COVID-19 treated in ICU

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital San Vicente Fundación
• Collaborators: Clínica Cardiovid; Clínica Las Américas; Clínica León XIII; Clínica Rosario El Tesoro; Clínica Universitaria Bolivariana; Grupo de Inmunodeficiencias primarias Universidad de Antioquia; Hospital Pablo Tobón Uribe

Criteria

Inclusion Criteria:

For plasma donors:

• Over 18 years of age

• Men or nulliparous women with no history of recent abortions or transfusions SARS-CoV-2 infection by PCR in any sample or serological test with a maximum of 60 days from resolution of symptoms.

• If donation is done within 14 to 28 days after resolution of symptoms, the patient must have a negative PCR test for SARS-CoV-2. If donation is done after 28 days of resolving symptoms, no negative control test will be required.

For plasma recipients:

• Over 18 years of age

• SARS-CoV-2 infection confirmed by PCR in any sample

• Hospitalized in the ICU due to shock or respiratory failure, with less than 24 hours after entering the ICU.

Exclusion Criteria:

For plasma donors:

• Severe SARS-CoV-2 infections with an ICU requirement or those with asymptomatic infections will not be accepted as donors.

• Nor will a person who has received convalescent plasma as part of the COVID-19 treatment.

For plasma receivers:

• Serious volume overload or other condition that contraindicates plasma transfusion.

• History of anaphylaxis or serious adverse reaction to plasma.

• Previous diagnosis of immunoglobulin A deficiency