CONVALESCENT PLASMA FOR ILL PATIENTS BY COVID-19 (COPLASCOV19)
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|ClinicalTrials.gov Identifier: NCT04356482|
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : June 5, 2020
The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients.
Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria.
So, our hypotheses are:
- Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19?
- the plasma dose with the minimum effective effect will improve the clinical, laboratory and clearance conditions of the presence of the virus in the severely ill patient?
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 SARS-CoV 2 Convalescence Plasma Doses||Biological: convalescent plasma||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DETERMINATION OF THE DOSE AND EFFECTIVENESS OF CONVALESCENT PLASMA IN SEVERELY AND VERY SEVERELY ILL PATIENTS BY COVID-19|
|Actual Study Start Date :||May 20, 2020|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: single arm
Determine the convalescent plasma dose to be administered to two groups: one severely ill (not intubated) and one very severely ill (intubated).
Second phase: safety and efficacy of the plasma dose found in the same two types of patients.
Biological: convalescent plasma
In phase 1, different amounts of convalescent plasma will be evaluated depending on the severity of the case.
In phase 2, both clinical, laboratory, imaging and viral presence (effectiveness) and safety will be evaluated.
Other Name: no apply
- Clinical improvement [ Time Frame: day -1 to day +22 ]no fever, respiratory improvement and blood oxygenation (Sat02, Sat02 / Fi02), general laboratory improvement.
- improvement in tomographic image [ Time Frame: day -1 to day +12 ]before convalescent plasma infusion, the CT image will be compared and subsequently the evolution of images in the CT will be evaluated every 72 hours on 3 times .
- test positivity for COVID-19 [ Time Frame: day +6 to day +12 ]the patients will be evaluated on three occasions the positivity of the test (PCR-RT). If two of them are negative, it will be defined as a virus-free patient.
- early and late complications associated to convalescent plasma [ Time Frame: day 0 to day +30 ]Patients will be evaluated for adverse events during the plasma infusion up to 30 days after that. Especially mild and severe allergic reactions (anaphylaxis), other issues like TRALI.
- days at ICU [ Time Frame: day 0 to day +30 ]days of stay at ICU will be evaluated
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): NCT04356482
|Contact: Luis M Villela, MDfirstname.lastname@example.org|
|Contact: Diego Espinoza, MDemail@example.com|
|Hospital Del Issste Regional En Guadalajara Jalisco||Not yet recruiting|
|Guadalajara, Jalisco, Mexico, 45100|
|Contact: CARLOS BEST, MD +523310722818 firstname.lastname@example.org|
|Secretaria de Salud Del Estado de Sonora, Hospital General Del Estado||Not yet recruiting|
|Hermosillo, Sonora, Mexico, 64890|
|Contact: LUIS villela, MD +526624756529 email@example.com|
|Contact: Melani Otañez, MD +526629374833 firstname.lastname@example.org|
|Sub-Investigator: Diego Espinoza, MD|
|Hospital Central Norte Pemex||Recruiting|
|Mexico City, Mexico, 02720|
|Contact: FERNANDO PEREZ-JACOBO, MD +525540821871 email@example.com|
|Principal Investigator:||Luis M Villela, MD||ISSSTESON|