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Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients With COVID-19 (Co-CLARITY)

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
Anti-SARS-CoV-2 convalescent plasma
Sponsored by
University of the Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Convalescent plasma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    1. Respiratory distress with requirement of O2 >6 lpm to maintain O2 sat >92%
    2. Rapid escalation of O2 requirement/significant work of breathing
    3. 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)

Sites / Locations

  • UP Philippine General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Anti-SARS-CoV-2 convalescent plasma

Standard of care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quick SOFA (qSOFA) score
Quick Sequential Organ Failure Assessment (qSOFA) scores of study participants within 28 days from enrollment. The qSOFA score is a rapid bedside clinical score used to identify patients with suspected infection that are at a greater risk for a poor outcome. Minimum score is 0 and maximum score is 3. A higher score is associated with higher risk for in-hospital mortality.
Cardiopulmonary arrest
Total number of patients experiencing cardiopulmonary arrest
ICU mortality
Total number of deaths among patients admitted to the ICU
ICU length of stay
Total number of days patients were admitted to the ICU
Hospital mortality
Total number of deaths among study participants
Hospital length of stay
Total number of days patients were admitted to the hospital
Dialysis-free days
Days without dialysis within 28 days from enrollment
Vasopressor-free days
Days without vasopressors within 28 days from enrollment
ICU-free days
Days without need for ICU admission within 28 days from enrollment
28-day mortality
Total number of patient deaths within 28 days from enrollment
Anti-SARS-CoV-2 antibody titers
Anti-SARS-CoV-2 IgG antibody titers
SARS-CoV-2 RNA by RT-PCR
Levels of SARS-CoV-2 RNA in nasopharyngeal swabs (or other specimen types as available) using RT-PCR

Full Information

First Posted
September 24, 2020
Last Updated
May 17, 2022
Sponsor
University of the Philippines
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1. Study Identification

Unique Protocol Identification Number
NCT04567173
Brief Title
Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients With COVID-19
Acronym
Co-CLARITY
Official Title
A Randomized, Open-Label, Single Center Clinical Trial to Assess the Efficacy and Safety of Convalescent Plasma to Hospitalized Adult COVID-19 Patients as Adjunctive Therapy to Reduce the Need for ICU Admission: Co-CLARITY Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Limited enrolment (unable to achieve target sample size)
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Philippines

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
This is a phase 3, randomized, non-placebo controlled, open-label, 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 hospitalized COVID-19 patients compared to standard of care. Consecutive patients with COVID-19 admitted to the UP Philippine General Hospital will be offered participation into the study. Patients in the intervention group will receive one dose of type-specific anti-SARS-CoV-2 convalescent plasma (500 mL collected by whole blood donation or standard pheresis at the UP-PGH blood bank from a volunteer who recovered from COVID-19). The primary safety endpoints include serious adverse events judged to be related to convalescent plasma. The study also aims to compare anti-SARS-CoV-2 antibody titers and rates, levels, and duration of SARS-CoV-2 RNA in nasopharyngeal swabs using RT-PCR between the intervention and control groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, Convalescent plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-SARS-CoV-2 convalescent plasma
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Anti-SARS-CoV-2 convalescent plasma
Intervention Description
convalescent plasma derived from whole blood donors or standard pheresis from a volunteer who recovered from COVID-19
Primary Outcome Measure Information:
Title
Incidence of serious adverse events
Description
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
Time Frame
28 days from enrollment
Secondary Outcome Measure Information:
Title
Quick SOFA (qSOFA) score
Description
Quick Sequential Organ Failure Assessment (qSOFA) scores of study participants within 28 days from enrollment. The qSOFA score is a rapid bedside clinical score used to identify patients with suspected infection that are at a greater risk for a poor outcome. Minimum score is 0 and maximum score is 3. A higher score is associated with higher risk for in-hospital mortality.
Time Frame
28 days from enrollment
Title
Cardiopulmonary arrest
Description
Total number of patients experiencing cardiopulmonary arrest
Time Frame
28 days from enrollment
Title
ICU mortality
Description
Total number of deaths among patients admitted to the ICU
Time Frame
28 days from enrollment
Title
ICU length of stay
Description
Total number of days patients were admitted to the ICU
Time Frame
28 days from enrollment
Title
Hospital mortality
Description
Total number of deaths among study participants
Time Frame
28 days from enrollment
Title
Hospital length of stay
Description
Total number of days patients were admitted to the hospital
Time Frame
28 days from enrollment
Title
Dialysis-free days
Description
Days without dialysis within 28 days from enrollment
Time Frame
28 days from enrollment
Title
Vasopressor-free days
Description
Days without vasopressors within 28 days from enrollment
Time Frame
28 days from enrollment
Title
ICU-free days
Description
Days without need for ICU admission within 28 days from enrollment
Time Frame
28 days from enrollment
Title
28-day mortality
Description
Total number of patient deaths within 28 days from enrollment
Time Frame
28 days from enrollment
Title
Anti-SARS-CoV-2 antibody titers
Description
Anti-SARS-CoV-2 IgG antibody titers
Time Frame
days 0, 1, 7 and 14 of enrollment
Title
SARS-CoV-2 RNA by RT-PCR
Description
Levels of SARS-CoV-2 RNA in nasopharyngeal swabs (or other specimen types as available) using RT-PCR
Time Frame
days 0, 1, 7 and 14 of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deonne Thaddeus V Gauiran, MD
Organizational Affiliation
UP Philippine General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UP Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines

12. IPD Sharing Statement

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

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