Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. 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: NCT04497324
Recruitment Status : Not yet recruiting
First Posted : August 4, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

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.


Condition or disease Intervention/treatment Phase
COVID-19 Biological: Convalescent plasma Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19
Estimated Study Start Date : August 20, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
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.
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.

No Intervention: Control group
Standard of care



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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): NCT04497324


Contacts
Layout table for location contacts
Contact: Fiorella Krapp Lopez, MD, MSc (511) 3190000 ext 201353 fiorella.krapp@upch.pe
Contact: Patricia Garcia Funegra, MD patricia.garcia@upch.pe

Locations
Layout table for location information
Peru
Hospital Nacional Hipolito Unanue
Lima, Peru
Contact: Alonso Soto, MD         
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Layout table for additonal information
Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT04497324    
Other Study ID Numbers: PER-016-20
20997 ( Registry Identifier: Peruvian Clinical Trial Registry (REPEC) )
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Peruana Cayetano Heredia:
COVID-19
Convalescent plasma