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

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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Drug: Anti-SARS-CoV-2 convalescent plasma

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Philippines
  • Manila, Philippines, 1000
    • UP Philippine General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-SARS-CoV-2 convalescent plasma; 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; convalescent plasma derived from whole blood donors or standard pheresis from a volunteer who recovered from COVID-19
No Intervention: Standard of care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days from enrollment
Cardiopulmonary arrest	Total number of patients experiencing cardiopulmonary arrest	28 days from enrollment
ICU mortality	Total number of deaths among patients admitted to the ICU	28 days from enrollment
ICU length of stay	Total number of days patients were admitted to the ICU	28 days from enrollment
Hospital mortality	Total number of deaths among study participants	28 days from enrollment
Hospital length of stay	Total number of days patients were admitted to the hospital	28 days from enrollment
Dialysis-free days	Days without dialysis within 28 days from enrollment	28 days from enrollment
Vasopressor-free days	Days without vasopressors within 28 days from enrollment	28 days from enrollment
ICU-free days	Days without need for ICU admission within 28 days from enrollment	28 days from enrollment
28-day mortality	Total number of patient deaths within 28 days from enrollment	28 days from enrollment
Anti-SARS-CoV-2 antibody titers	Anti-SARS-CoV-2 IgG antibody titers	days 0, 1, 7 and 14 of enrollment
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	days 0, 1, 7 and 14 of enrollment

Collaborators and Investigators

• Sponsor: University of the Philippines
• Investigators: Principal Investigator: Deonne Thaddeus V Gauiran, MD, UP Philippine General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Convalescent plasma
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PHRR200824-002868

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No