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OpenTrials
Completed

NCT Number: NCT04375098

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

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.

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Key information

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Clínico Universidad Católica

Santiago, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

COVID-19 Convalescent Plasma

Biological

COVID-19 convalescent plasma

Primary outcomes

  1. Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization

    Time frame: 1 year follow up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Collaborators

  • Fundacion Arturo Lopez Perez

Registry information

Official study title

Efficacy and Safety of Early Anti-SARS-COV-2 Convalescent Plasma in Patients Admitted for COVID-19 Infection: a Randomized Phase II Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 5, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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