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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567173
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Deonne Thaddeus Gauiran, University of the Philippines

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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Anti-SARS-CoV-2 convalescent plasma Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : September 21, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

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



Primary Outcome Measures :
  1. Incidence of serious adverse events [ Time Frame: 28 days from enrollment ]
    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 :
  1. Quick SOFA (qSOFA) score [ Time Frame: 28 days from enrollment ]
    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.

  2. Cardiopulmonary arrest [ Time Frame: 28 days from enrollment ]
    Total number of patients experiencing cardiopulmonary arrest

  3. ICU mortality [ Time Frame: 28 days from enrollment ]
    Total number of deaths among patients admitted to the ICU

  4. ICU length of stay [ Time Frame: 28 days from enrollment ]
    Total number of days patients were admitted to the ICU

  5. Hospital mortality [ Time Frame: 28 days from enrollment ]
    Total number of deaths among study participants

  6. Hospital length of stay [ Time Frame: 28 days from enrollment ]
    Total number of days patients were admitted to the hospital

  7. Dialysis-free days [ Time Frame: 28 days from enrollment ]
    Days without dialysis within 28 days from enrollment

  8. Vasopressor-free days [ Time Frame: 28 days from enrollment ]
    Days without vasopressors within 28 days from enrollment

  9. ICU-free days [ Time Frame: 28 days from enrollment ]
    Days without need for ICU admission within 28 days from enrollment

  10. 28-day mortality [ Time Frame: 28 days from enrollment ]
    Total number of patient deaths within 28 days from enrollment

  11. Anti-SARS-CoV-2 antibody titers [ Time Frame: days 0, 1, 7 and 14 of enrollment ]
    Anti-SARS-CoV-2 IgG antibody titers

  12. SARS-CoV-2 RNA by RT-PCR [ Time Frame: days 0, 1, 7 and 14 of enrollment ]
    Levels of SARS-CoV-2 RNA in nasopharyngeal swabs (or other specimen types as available) using RT-PCR



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567173


Contacts
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Contact: Deonne Thaddeus V Gauiran, MD +639088150248 dvgauiran@up.edu.ph
Contact: Teresita E Dumagay, MD +639228198436 tedumagay@up.edu.ph

Locations
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Philippines
UP Philippine General Hospital Recruiting
Manila, Philippines, 1000
Contact: Deonne Thaddeus V Gauiran, MD    +639088150248    dvgauiran@up.edu.ph   
Contact: Teresita E Dumagay, MD    +639228198436    tedumagay@up.edu.ph   
Principal Investigator: Teresita E Dumagay, MD         
Sub-Investigator: Mark Angelo Ang, MD         
Sub-Investigator: Cecile D Dungog, MD         
Sub-Investigator: Fresthel Monica M Climacosa, MD PhD         
Sub-Investigator: Sandy Chiong Maganito, MD         
Sub-Investigator: Rachelle Alfonso, MD         
Sub-Investigator: Anne Kristine H Quero, MD         
Sub-Investigator: Josephine Anne Lucero, MD         
Sub-Investigator: Carlo Francisco N Cortez, MD         
Sub-Investigator: Agnes Evasan, MD         
Sub-Investigator: Ruby Anne N King, MD PhD         
Sub-Investigator: Francisco M Heralde III, PhD         
Sub-Investigator: Lynn B Bonifacio, MD         
Sub-Investigator: German J Castillo Jr, MD         
Sub-Investigator: Ivy Mae S Escasa, MD         
Sub-Investigator: Maria Clariza M Santos, MD         
Sub-Investigator: Anna Flor Malundo, MD         
Sub-Investigator: Alric V Mondragon, MD         
Sub-Investigator: Januario Veloso, MD         
Sub-Investigator: Jose M Carnate Jr, MD         
Sub-Investigator: Pedrito Y Tagayuna, MD         
Sub-Investigator: Jodor Lim, MD         
Sub-Investigator: Marissa Alejandria, MD MSc         
Sub-Investigator: Ma Angelina L Mirasol, MD         
Sponsors and Collaborators
University of the Philippines
Investigators
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Principal Investigator: Deonne Thaddeus V Gauiran, MD UP Philippine General Hospital
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Responsible Party: Deonne Thaddeus Gauiran, Principal Investigator, University of the Philippines
ClinicalTrials.gov Identifier: NCT04567173    
Other Study ID Numbers: PHRR200824-002868
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deonne Thaddeus Gauiran, University of the Philippines:
COVID-19
Convalescent plasma