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NCT Number: NCT04497324

PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19

Open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with COVID-19 infection. This study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. Adults older than 18 years old, hospitalized with diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or life-threatening disease, will be included to the study after obtaining inform consent by the patient of a direct family member. Participants will be then randomized 1:1 to the experimental and the control groups.

Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of care. Participants at the control group will receive standard of care. Safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy.

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Key information

Conditions

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 Cayetano Heredia, Lima, Peru

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About this study

The study protocol can be found in:

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation.
  • Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria:
  • Respiratory frequency >22
  • O2 saturation ≤93%
  • PaO2 50mmHg
  • PaO2/FiO2 <300
  • Or critical disease with one or more of the following criteria:
  • Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours
  • Shock
  • Inform consent signed by patient or direct family member.

Exclusion criteria

  • Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components
  • Multiorgan failure, defined by a SOFA score of >5
  • hemodynamically unstable, with mean arterial pressure <60 mmHg, refractory to vasopressors use
  • Uncontrolled concomitant infection
  • Disseminated intravascular coagulation
  • Myocardial infarction
  • Acute coronary disease
  • Patient on dialysis
  • Intracranial bleeding active within the last 7 days
  • Pregnancy

Treatment and study plan

Convalescent Plasma

Biological

Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.

Primary outcomes

  1. Transfusion-related Serious Adverse Events

    Time frame: 14 days after randomization

    Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2

Secondary outcomes

  1. All-cause in-hospital mortality

    Time frame: 30 days after randomization

    Death during hospitalization within the first 30 days after enrollment

  2. Length of hospital stay

    Time frame: 30 days after randomization or until hospital discharge, whatever comes first

    Number of days from date of enrollment to date of discharge

  3. Length of ICU stay

    Time frame: 30 days after randomization or until hospital discharge, whatever comes first

    Number of days from date of admission to the ICU to date of discharge from ICU

  4. Need of invasive mechanical ventilation

    Time frame: 30 days after randomization or until hospital discharge, whatever comes first

    Requirement of invasive mechanical ventilation (Yes/No). Evaluated only for those participants that were on non-invasive ventilatory support at time of randomization

  5. Duration of mechanical ventilation

    Time frame: 30 days after randomization or until hospital discharge, whatever comes first

    Number of days from date of intubation to date of successful extubation

  6. Clinical Improvement at 14 days

    Time frame: At 3, 14 and 30 days after randomization

    Improvement of 2 or more points in the WHO progression scale

Sponsors and collaborators

Lead sponsor

Universidad Peruana Cayetano Heredia

Other

Registry information

Official study title

PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2020
Registry last updated
Oct 28, 2021

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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