Clinical trial NCT04497324: PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19
Official title: PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
Convalescent plasma
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Transfusion-related Serious Adverse Events
timeFrame: 14 days after randomization
Secondary outcomes:
measure: All-cause in-hospital mortality
timeFrame: 30 days after randomization
measure: Length of hospital stay
timeFrame: 30 days after randomization or until hospital discharge, whatever comes first
measure: Length of ICU stay
timeFrame: 30 days after randomization or until hospital discharge, whatever comes first
measure: Need of invasive mechanical ventilation
timeFrame: 30 days after randomization or until hospital discharge, whatever comes first
measure: Duration of mechanical ventilation
timeFrame: 30 days after randomization or until hospital discharge, whatever comes first
measure: Clinical Improvement at 14 days
timeFrame: At 3, 14 and 30 days after randomization
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Hospital Cayetano Heredia
city: Lima
country: Peru
facility: Hospital Nacional Hipolito Unanue
Study officials:
affiliation: Universidad Peruana Cayetano Heredia
name: Fiorella Krapp Lopez, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Peruana Cayetano Heredia
name: Patricia Garcia Funegra, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soto A, Krapp F, Vargas A, Cabrejos L, Argumanis E, Garcia PL, Altamirano K, Montes M, Chacon-Uscamaita PR, Garcia 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.