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

NCT ID: NCT04497324

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2021-04-17

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

Conditions

COVID-19

Keywords

COVID-19; Convalescent plasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Convalescent plasma

Intervention Type: BIOLOGICAL

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

Control group

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Convalescent plasma

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fiorella Krapp Lopez, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad Peruana Cayetano Heredia

Patricia Garcia Funegra, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad Peruana Cayetano Heredia

Locations

Hospital Cayetano Heredia

Lima, , Peru

Hospital Nacional Hipolito Unanue

Lima, , Peru

Countries

Peru

References

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.

Reference Type: DERIVED

PMID: 34001174 (View on PubMed)

Other Identifiers

20997

Identifier Type: REGISTRY

Identifier Source: secondary_id

PER-016-20

Identifier Type: -

Identifier Source: org_study_id