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Efficacy and Safety of Early COVID-19 Convalescent Plasma in Patients Admitted for COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04375098
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Fundacion Arturo Lopez Perez
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief Summary:
Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.

Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome Coronavirus 2 Biological: COVID-19 convalescent plasma Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Early Anti-SARS-COV-2 Convalescent Plasma in Patients Admitted for COVID-19 Infection: a Randomized Phase II Trial
Actual Study Start Date : May 4, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early COVID-19 convalescent plasma
COVID-19 convalescent plasma 200 ml day 1 and 2 at admission after confirmation of eligibility
Biological: COVID-19 convalescent plasma
COVID-19 convalescent plasma

Experimental: COVID-19 convalescent plasma
COVID-19 convalescent plasma 200 ml day 1 and 2 only if worsening of respiratory function or persistence of COVID symptoms for >7 days after enrolment
Biological: COVID-19 convalescent plasma
COVID-19 convalescent plasma




Primary Outcome Measures :
  1. Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization [ Time Frame: 1 year follow up ]

Secondary Outcome Measures :
  1. Median duration of fever [ Time Frame: 1 year ]
    Days

  2. Median duration of mechanical ventilation [ Time Frame: 1 year follow up ]
    Days

  3. Median length of ICU stay [ Time Frame: 1 year follow up ]
    Days

  4. Median length of admission [ Time Frame: 1 year follow up ]
    Days

  5. Hospital mortality rate (percentage) [ Time Frame: 1 year follow up ]
  6. 30-day mortality (percentage) [ Time Frame: 1 year follow up ]
  7. Readmission rate (percentage) [ Time Frame: 1 year follow up ]
  8. Median length of viral clearance [ Time Frame: 1 year follow up ]
    days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient older than 18 years
  • CALL score ≥ 9 (progression risk score)
  • PCR-confirmed COVID-19 infection with equal or less than 7 days of symptoms (or imaging consistent with COVID-19 pneumonia and confirmed COVID-19 contact)
  • Any symptoms of COVID-19 infection
  • Admission due to COVID-19 infection
  • Signed informed consent
  • ECOG before COVID-19 infection 0-2

Exclusion Criteria:

  • PaFi <200 or mechanical ventilation indication
  • Clinically relevant co-infection at admission
  • Pregnancy or lactation
  • IgA deficiency or IgA nephropathy
  • Immunoglobulin or plasma administration in the last 60 days
  • Contraindication to transfusion or previous allergy to blood-derived products
  • Do-not-resuscitate status
  • Patients receiving other investigational drug for COVID-19 in a clinical trial
  • Any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results.

Information from the National Library of Medicine

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): NCT04375098


Contacts
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Contact: Maria Elvira Balcells, MD +562 23543508 ebalcells@uc.cl

Locations
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Chile
Hospital Clínico Universidad Católica Recruiting
Santiago, Chile
Contact: Maria Elvira Balcells, MD    +562 23543508    ebalcells@uc.cl   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Fundacion Arturo Lopez Perez
Investigators
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Principal Investigator: Maria Elvira Balcells, MD ebalcells@uc.cl
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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT04375098    
Other Study ID Numbers: 200415015
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pontificia Universidad Catolica de Chile:
Plasma
COVID-19
severe acute respiratory syndrome coronavirus 2
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases