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 :
Completed
First Posted : April 24, 2020
Last Update Posted : May 26, 2021
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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) |
Actual Enrollment : | 31 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | RCT double blind comparative study |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | double blind |
Primary Purpose: | Treatment |
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 |
Actual Primary Completion Date : | May 1, 2021 |
Actual Study Completion Date : | May 1, 2021 |

Arm | Intervention/treatment |
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Experimental: Plasma
Convalescent plasma from cured COVID-19 patients y Supportive management depending on individual needs
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Biological: Plasma
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.
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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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men or women ≥18 years. If you are a woman of childbearing age, you must agree to practice abstinence or to use an effective method of contraception during the study period.
- Vascular access suitable for administration of hemocomponents.
- SARS-CoV-2 positive RT-PCR.
- Negative pregnancy test in case of a woman of reproductive age
- Signing of evidentiary document of informed consent.
- Hospital admission for SARS-CoV-2 pneumonia with supplemental oxygen requirements.
- Subjects who access the storage of biological samples for future examination.
Exclusion Criteria:
- Respiratory rate >30 RPM, SO2 <93%, PaO2/FiO2 <200 despite intervention with oxygen therapy after 60 minutes of hospitalization.
- New alteration of the state of alert that does not revert after interventions 60 minutes after admission to hospital.
- PAM ≤ 65mmHg despite initial resuscitation on arrival at the centre.
- Pregnant or breastfeeding patients.
- Patients that the investigators consider inappropriate to participate in the clinical trial
- Contraindication to transfusion or history of previous severe reaction to blood products.
- Have received any blood products in the last 120 days.

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
Mexico | |
Hospital Universitario José E. Gonzalez | |
Monterrey, Nuevo Leon, Mexico, 64460 |
Principal Investigator: | Adrian Camacho-Ortiz, MD | Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL |
Responsible Party: | Dr. Adrian Camacho-Ortiz, Head of the Infectious Disease Department, Hospital Universitario Dr. Jose E. Gonzalez |
ClinicalTrials.gov Identifier: | NCT04358783 |
Other Study ID Numbers: |
IF20-00002 |
First Posted: | April 24, 2020 Key Record Dates |
Last Update Posted: | May 26, 2021 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
COVID-19 Plasma from patients cured SARS-CoV-2 pneumonia |
Pneumonia Coronavirus Infections Respiratory Tract Infections Infections Lung Diseases |
Respiratory Tract Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases |