Clinical trial NCT04567173: Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients With COVID-19
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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Covid19
Keywords: COVID-19
Convalescent plasma
Lead sponsor: University of the Philippines
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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:

  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)

Primary outcomes:
measure: Incidence of serious adverse events
timeFrame: 28 days from enrollment
Secondary outcomes:
measure: Quick SOFA (qSOFA) score
timeFrame: 28 days from enrollment
measure: Cardiopulmonary arrest
timeFrame: 28 days from enrollment
measure: ICU mortality
timeFrame: 28 days from enrollment
measure: ICU length of stay
timeFrame: 28 days from enrollment
measure: Hospital mortality
timeFrame: 28 days from enrollment
measure: Hospital length of stay
timeFrame: 28 days from enrollment
measure: Dialysis-free days
timeFrame: 28 days from enrollment
measure: Vasopressor-free days
timeFrame: 28 days from enrollment
measure: ICU-free days
timeFrame: 28 days from enrollment
measure: 28-day mortality
timeFrame: 28 days from enrollment
measure: Anti-SARS-CoV-2 antibody titers
timeFrame: days 0, 1, 7 and 14 of enrollment
measure: SARS-CoV-2 RNA by RT-PCR
timeFrame: days 0, 1, 7 and 14 of enrollment
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: UP Philippine General Hospital
Study officials:
affiliation: UP Philippine General Hospital
name: Deonne Thaddeus V Gauiran, MD
role: PRINCIPAL_INVESTIGATOR
References: