Convalescent Plasma Compared to the Best Available Therapy for the Treatment of SARS-CoV-2 Pneumonia (COP-COVID-19)
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|ClinicalTrials.gov Identifier: NCT04358783|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 19, 2020
In early December 2019, cases of pneumonia of unknown origin were identified in Wuhan, China. The causative virus was called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) has recently declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern.
According to the World Health Organization (WHO), the management of COVID-19 has focused primarily on infection prevention, detection and patient monitoring. However, there is no vaccine or specific treatment for SARS-CoV-2 due to the lack of evidence. Treatment options currently include broad-spectrum antiviral drugs but the efficacy and safety of these drugs is still unknown.
Convalescent plasma has previously been used to treat various outbreaks of other respiratory infections; however, it has not been shown to be effective in all the diseases studied. Therefore, clinical trials are required to demonstrate its safety and efficacy in patients with VIDOC-19.
The present work seeks to determine the mortality from any cause up to 14 days after plasma randomization of patients cured of COVID-19 compared to the Best Available Therapy in subjects with SARS-CoV-2 pneumonia. This is a 2:1 randomized, double-blind, single-center, phase 2, controlled clinical trial (plasma: best available therapy) for the treatment of SARS-CoV-2 pneumonia.
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infection||Biological: Plasma Other: Best Available Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||RCT double blind comparative study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||double blind|
|Official Title:||Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Plasma From Patients Cured of COVID-19 Compared to the Best Available Therapy in Subjects With SARS-CoV-2 Pneumonia|
|Actual Study Start Date :||April 27, 2020|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||May 30, 2021|
Convalescent plasma from cured COVID-19 patients y Supportive management depending on individual needs
The plasma unit will be fractionated in 200 mL aliquots for storage at -80°C until use. After thawing, it shall be administered in a single 200 mL dose to subjects who are randomized to that arm.
Experimental: Best Available Therapy
Will receive supportive management depending on individual needs including.
Other: Best Available Therapy
It shall include, but not be limited to, oxygen therapy by means of a nasal cannula; high-flow nasal cannula; invasive or non-invasive mechanical ventilation; intravenous hydration; antibiotic therapy; thrombus prophylaxis; pain and fever management.
- Early all-cause mortality [ Time Frame: 14 days ]any cause mortality during the first 14 days of treatment
- Time in days for SARS-CoV-2 RT-PCR negatives [ Time Frame: 90 days ](48-hour sampling interval from day 3 of hospitalization to two consecutive negatives).
- The serum anti-SARS-CoV-2 antibody titres [ Time Frame: 90 days ]In subjects of both arms at day 0, 3, 7, 14 and 90.
- Detection of serum antibodies [ Time Frame: days 0, 3, 7, 14 and 90. ]Comparison of anti-SARS-CoV-2 antibody titers
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): NCT04358783
|Contact: Eduardo Pérez Alba, MD||+52 email@example.com|
|Contact: Laura Marina Nuzzolo Shihadeh, MD||+52 firstname.lastname@example.org|
|Hospital Universitario José E. Gonzalez||Recruiting|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Contact: Adrian Camacho, PHD 044 81 1263 5696 email@example.com|
|Sub-Investigator: Eduardo Pérez Alba, MD|
|Sub-Investigator: Laura Marina Nuzzolo Shihadeh, MD|
|Sub-Investigator: David Gómez Almaguer, MD|
|Sub-Investigator: Dalila M. Alvarado Navarro, MD|
|Sub-Investigator: Andrés Gómez de León, MD|
|Sub-Investigator: Elvira Garza González, MD|
|Sub-Investigator: Jorge Llaca Diaz, MD|
|Sub-Investigator: María del Rosario Salazar Riojas., MD|
|Principal Investigator: Adrian Camacho, PHD|
|Principal Investigator:||Adrian Camacho-Ortiz, MD||Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL|