Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients With COVID-19

NCT04567173 | Terminated Phase 2

• 1 other identifier: PHRR200824-002868
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol provides access to investigational convalescent plasma for hospitalized patients with COVID-19. Following provision of informed consent, patients will be administered around 500 mL of convalescent plasma obtained from an individual who has recovered from a documented SARS-CoV-2 infection. The study aims to evaluate the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as adjunctive therapy in preventing disease progression (prevention of ICU admission) among hospitalized patients with COVID-19. Safety outcomes include serious adverse events judged to be related to convalescent plasma. Other information which will be collected includes patient demographics and clinical data which includes quick SOFA scores, ventilator-free days, ICU-free days, dialysis-free days and 28-day mortality.

Conditions

Covid19

Keywords

COVID-19; Convalescent plasma

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse events

  Cumulative incidence of serious adverse events (transfusion-related acute lung injury, transfusion associated circulatory overload, transfusion related infection and anaphylaxis/severe allergic reactions) during the study period

  28 days from enrollment

Secondary Outcomes (12)

• Quick SOFA (qSOFA) score

  28 days from enrollment

• Cardiopulmonary arrest

  28 days from enrollment

• ICU mortality

  28 days from enrollment

• ICU length of stay

  28 days from enrollment

• Hospital mortality

  28 days from enrollment

Study Arms (2)

Anti-SARS-CoV-2 convalescent plasma

EXPERIMENTAL

About 500 mL of type-specific anti-SARS-CoV-2 convalescent plasma collected by whole blood donation or standard pheresis from a volunteer who recovered from COVID-19 transfused intravenously as 2 aliquots of 250 mL

Drug: Anti-SARS-CoV-2 convalescent plasma

Standard of care

NO INTERVENTION

Patients in the control group are those will only receive local standard of care as deemed appropriate by the primary attending physicians and guided by institutional pathways

Interventions

Anti-SARS-CoV-2 convalescent plasma DRUG

convalescent plasma derived from whole blood donors or standard pheresis from a volunteer who recovered from COVID-19

Anti-SARS-CoV-2 convalescent plasma

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be 19 years of age or older
• Hospitalized with COVID-19 and confirmed via SARS-CoV-2 RT-PCR testing
• Patient is willing and able to provide written consent and comply with all protocol requirements
• Patient agrees to storage of specimens for future testing

You may not qualify if:

• Female subjects with positive pregnancy test, are breastfeeding or planning to become pregnant/breastfeed during the study period
• Symptomatic illness exceeding 14 days from onset of illness at time of enrollment
• ICU admission on initial presentation at the hospital (includes patients with clinical indications for ICU admission as follows:
• Respiratory distress with requirement of O2 \>6 lpm to maintain O2 sat \>92%
• Rapid escalation of O2 requirement/significant work of breathing
• Hemodynamic instability: SBP \<90, MAP \<65
• Receipt of any blood products including pooled immunoglobulin or intravenous immunoglobulin (IVIg) in the past 30 days prior to enrolment
• Known IgA deficiency
• Presence of any contraindication to transfusion (or history of prior severe reactions to transfusion of blood products)

Sponsors & Collaborators

• University of the Philippines: lead

Study Sites (1)

UP Philippine General Hospital

Manila, 1000, Philippines

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Deonne Thaddeus V Gauiran, MD

  UP Philippine General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a phase 3, randomized, non-placebo controlled, open-label, non-blinded, single-center clinical trial which will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma given from the 3rd to 14th day of illness after the onset of symptoms in preventing ICU admission among COVID-19 patients compared to standard of care. Consequently enrolled patients will be randomized using the REDCap randomization module

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 28, 2020
• Study Start: September 21, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

PH (1)