Safety in Convalescent Plasma Transfusion to COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04333355|
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: Convalescent Plasma||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection|
|Estimated Study Start Date :||May 25, 2020|
|Estimated Primary Completion Date :||December 20, 2020|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: COVID-19 patients receiving Convalescent Plasma
Convalescent Plasma from patients who recently recover from COVID-19
Biological: Convalescent Plasma
Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.
Other Name: Supportive standard care
- Side effects [ Time Frame: 14 days ]Identify possible adverse effects after the administration of convalescent plasma
- Heart Failure [ Time Frame: 14 days ]Development of heart failure during convalescent plasma transfusion or after it.
- Pulmonary Edema [ Time Frame: 14 days ]Development of pulmonary edema during convalescent plasma transfusion or after it.
- Allergic Reaction [ Time Frame: 14 days ]Development of any allergic reaction during convalescent plasma transfusion or after it.
- Viral load of SARS-CoV-2 [ Time Frame: 48 hrs ]RT PCR SARS-CoV-2
- Viral load of SARS-CoV-2 [ Time Frame: 14 days ]RT PCR SARS-CoV-2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333355
|Contact: Servando Cardona-Huerta, MD., Ph. D.||+email@example.com|
|Contact: Sylvia De la Rosa, MDfirstname.lastname@example.org|
|Hospital San José||Recruiting|
|Monterrey, Nuevo Leon, Mexico, 64718|
|Contact: Servando Cardona-Huerta, MD, PhD +5218112121946 email@example.com|
|Contact: Sylvia de la Rosa-Pacheco, MD +5218111832730 firstname.lastname@example.org|
|Principal Investigator: José Fe Castilleja-Leal, MD|
|Principal Investigator:||José Fe Castilleja-Leal, MD.||Hospital San José|