Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease (PC-COVID-HCM)

May 6, 2021 updated by: Hospital Central Militar

Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease

Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Our primary outcomes will be disease progression and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)

Study Type

Interventional

Enrollment (Actual)

150

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
      • Mexico City, Mexico, 11200
        • Hospital Central Militar

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • O2 saturation <93%
  • Radiographic evidence of moderate pneumonia according to Rale's classification.
  • Acute respiratory distress syndrome (PaO2 / FiO2 <300 or SpO2 / FiO2 ≤ 315)
  • Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated)

Exclusion Criteria:

  • Pregnant patients
  • History of transfusion reactions
  • Patients with congestive heart failure
  • Patients with a history of chronic kidney failure on dialysis
  • Patients with multiple organ failure
  • Patients who does not accept or agree with the treatment.

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
No Intervention: Control group
They will receive the standard care for critically ill inpatients.
Experimental: Convalescent plasma group.
They will receive standard care for patients with severe COVID-19 disease and convalescent plasma disease.
Biological: Biological

An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses.

If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out.

Other Names:
  • Convalescent plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease progression
Time Frame: Up to 30 days later from study entry
Change in ordinal Scale for Clinical Improvement (WHO). The progression disease, its the change in the severity score; a bigger number to the obtained after randomization
Up to 30 days later from study entry
Side effects
Time Frame: Up to 30 days later from study entry
Side effects associated with the administration of convalescent plasma
Up to 30 days later from study entry
Mortality
Time Frame: Up to 30 days later from study entry
Any cause of death
Up to 30 days later from study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory improvement
Time Frame: 10 days
Change in partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio (PaO2/FiO2)
10 days
Clinical improvement
Time Frame: 10 days
Change in oxygen saturation levels
10 days
Acute adverse events (AAE)
Time Frame: After receiving intervention, an average time one hour, until 24 hours after administration.
Transfusion reactions during transfusion.
After receiving intervention, an average time one hour, until 24 hours after administration.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory biomarkers (D dimer)
Time Frame: 10 days
Change in pro-inflammatory biomarkers (D dimer μg/l)
10 days
Inflammatory biomarkers (Ferritin)
Time Frame: 10 days
Change in pro-inflammatory biomarkers ( Ferritin μg/L )
10 days
Inflammatory biomarkers (CPR)
Time Frame: 10 days
Change in pro-inflammatory biomarkers, C-reactive protein ( CPR mg/L )
10 days
Inflammatory biomarkers (LDH)
Time Frame: 10 days
Change in pro-inflammatory biomarkers, lactate dehydrogenase ( LDH UI/L)
10 days

Collaborators and Investigators

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

Sponsor

Hospital Central Militar

Investigators

  • Principal Investigator: Carmen G Torres, MD, Hospital Central Militar

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.

Helpful Links

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)

June 23, 2020

Primary Completion (Actual)

September 2, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

September 4, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 047/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to make IPD still not decided and would need approval by regulatory authorities

IPD Sharing Time Frame

From 6 months after publication

IPD Sharing Access Criteria

PRIOR APPLICATION

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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