Safety in Convalescent Plasma Transfusion to COVID-19

Phase 1

Terminated

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

• Registration Number: NCT04333355
• Lead Sponsor: Hospital San Jose Tec de Monterrey

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-03
• Study Start: 2020-05-08
• Primary Completion: 2020-08-20
• Study Completion: 2020-08-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with a history of allergic reaction to any type of previous transfusion.
2. Heart failure patients at risk of volume overload.
3. Patients with a history of chronic kidney failure in the dialysis phase.
4. Patients with previous hematological diseases (anemia less than 10 grams of hemoglobin, platelets greater than 100,000 / µl).
5. Any case where the investigator decides that the patient is not suitable for the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COVID-19 patients receiving Convalescent Plasma	Convalescent Plasma	Convalescent Plasma from patients who recently recover from COVID-19

Primary Outcome Measures

Name	Time	Method
Side effects	14 days	Identify possible adverse effects after the administration of convalescent plasma

Secondary Outcome Measures

Name	Time	Method
Pulmonary Edema	14 days	Development of pulmonary edema during convalescent plasma transfusion or after it.
Viral load of SARS-CoV-2	14 days	RT PCR SARS-CoV-2
Heart Failure	14 days	Development of heart failure during convalescent plasma transfusion or after it.
Allergic Reaction	14 days	Development of any allergic reaction during convalescent plasma transfusion or after it.

Trial Locations

Locations (1)

Hospital San José; 🇲🇽 Monterrey, Nuevo Leon, Mexico