NCT04333355

Safety in Convalescent Plasma Transfusion to COVID-19

Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: TecSalud Investigación Clínica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. This plasma will be infused in patients affected by the same virus, but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. The investigator will evaluate the safety of this procedure by accounting for any adverse event.

Detailed description

There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. Donors will be screened for infectious diseases including sARS-CoV-2 and will be programmed for apheresis the next day. The investigaotr will process one plasmatic volume per donor and this will be guarded in the blood bank until required by the principal investigator. Patients or receptors will be screened and selected by the research team according to eligibility criteria, including severe disease refractory to treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. Plasma will be fractioned in 250ml. Infusion will start after a clinical evaluation and blood sampling. Patients will remain under careful observation. If no adverse event is present, infusion will be repeated after 24 hours and the investigator will evaluate patients again 48 hours after the second transfusion. A final evaluation will be performed at day 14. The investigator will evaluate the safety of this procedure by accounting for any adverse event.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Convalescent Plasma	Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.

Timeline

• Start date: 2020-05-08
• Primary completion: 2020-08-20
• Completion: 2020-08-20
• First posted: 2020-04-03
• Last updated: 2021-02-10

Locations

1 site across 1 country: Mexico