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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497324
Recruitment Status : Completed
First Posted : August 4, 2020
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

Tracking Information
First Submitted Date  ICMJE July 31, 2020
First Posted Date  ICMJE August 4, 2020
Last Update Posted Date October 28, 2021
Actual Study Start Date  ICMJE September 21, 2020
Actual Primary Completion Date April 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2020)
  • All-cause in-hospital mortality [ Time Frame: 30 days after randomization ]
    Death during hospitalization within the first 30 days after enrollment
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19
Official Title  ICMJE PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19
Brief Summary

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.

Detailed Description

The study protocol can be found in:

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Biological: Convalescent plasma
Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.
Study Arms  ICMJE
  • Experimental: Experimental group
    Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.
    Intervention: Biological: Convalescent plasma
  • No Intervention: Control group
    Standard of care
Publications * Soto A, Krapp F, Vargas A, Cabrejos L, Argumanis E, García PL, Altamirano K, Montes M, Chacón-Uscamaita PR, García PJ. Randomized clinical trial to evaluate safety and efficacy of convalescent plasma use among hospitalized patients with COVID-19 (PERUCONPLASMA): a structured summary of a study protocol for a randomized controlled trial. Trials. 2021 May 17;22(1):342. doi: 10.1186/s13063-021-05189-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 17, 2021
Actual Primary Completion Date April 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04497324
Other Study ID Numbers  ICMJE PER-016-20
20997 ( Registry Identifier: Peruvian Clinical Trial Registry (REPEC) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universidad Peruana Cayetano Heredia
Study Sponsor  ICMJE Universidad Peruana Cayetano Heredia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fiorella Krapp Lopez, MD, MSc Universidad Peruana Cayetano Heredia
Principal Investigator: Patricia Garcia Funegra, MD, MSc Universidad Peruana Cayetano Heredia
PRS Account Universidad Peruana Cayetano Heredia
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP