Convalescent Plasma Compared to the Best Available Therapy for the Treatment of SARS-CoV-2 Pneumonia (COP-COVID-19)

May 24, 2021 updated by: Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized clinical trial comparing convalescent plasma to best available therapy (BAT) for the treatment of severely ill and critically ill patient with COVID-19: Patients will be electronically randomized 2:1 (plasma vs BAT) in a double blind fashion. Patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Primary outcomes will be early all-cause mortality, and secondary outcomes will include all cause in hospital mortality, length of mechanical ventilation and hospital stay, time to PAO2 >200, progression of pulmonary infiltrates, antibody titers and time to negative PCR detection

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Hospital Universitario José E. Gonzalez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Vascular access suitable for administration of hemocomponents.
  3. SARS-CoV-2 positive RT-PCR.
  4. Negative pregnancy test in case of a woman of reproductive age
  5. Signing of evidentiary document of informed consent.
  6. Hospital admission for SARS-CoV-2 pneumonia with supplemental oxygen requirements.
  7. Subjects who access the storage of biological samples for future examination.

Exclusion Criteria:

  1. Respiratory rate >30 RPM, SO2 <93%, PaO2/FiO2 <200 despite intervention with oxygen therapy after 60 minutes of hospitalization.
  2. New alteration of the state of alert that does not revert after interventions 60 minutes after admission to hospital.
  3. PAM ≤ 65mmHg despite initial resuscitation on arrival at the centre.
  4. Pregnant or breastfeeding patients.
  5. Patients that the investigators consider inappropriate to participate in the clinical trial
  6. Contraindication to transfusion or history of previous severe reaction to blood products.
  7. Have received any blood products in the last 120 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plasma
Convalescent plasma from cured COVID-19 patients y Supportive management depending on individual needs
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early all-cause mortality
Time Frame: 14 days
any cause mortality during the first 14 days of treatment
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
90 days
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.
90 days
Detection of serum antibodies
Time Frame: days 0, 3, 7, 14 and 90.
Comparison of anti-SARS-CoV-2 antibody titers
days 0, 3, 7, 14 and 90.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Principal Investigator: Adrian Camacho-Ortiz, MD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IF20-00002

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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