Covid19Phase 2/3Co-CLARITYNCT04567173
Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients With COVID-19
A Phase 2/3 study testing Anti-SARS-CoV-2 convalescent plasma in people with Covid19, run by University of the Philippines at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Anti-SARS-CoV-2 convalescent plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePhilippines
- Study dates
- 21 Sep 2020to 30 Jun 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Anti-SARS-CoV-2 convalescent plasma
- Keywords
- COVID-19, Convalescent plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-SARS-CoV-2 convalescent plasmaDrug
convalescent plasma derived from whole blood donors or standard pheresis from a volunteer who recovered from COVID-19
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days from enrollment
Secondary outcomes (12)
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.
Measured: 28 days from enrollment
Cardiopulmonary arrest
Total number of patients experiencing cardiopulmonary arrest
Measured: 28 days from enrollment
ICU mortality
Total number of deaths among patients admitted to the ICU
Measured: 28 days from enrollment
ICU length of stay
Total number of days patients were admitted to the ICU
Measured: 28 days from enrollment
Hospital mortality
Total number of deaths among study participants
Measured: 28 days from enrollment
Hospital length of stay
Total number of days patients were admitted to the hospital
Measured: 28 days from enrollment
Dialysis-free days
Days without dialysis within 28 days from enrollment
Measured: 28 days from enrollment
Vasopressor-free days
Days without vasopressors within 28 days from enrollment
Measured: 28 days from enrollment
ICU-free days
Days without need for ICU admission within 28 days from enrollment
Measured: 28 days from enrollment
28-day mortality
Total number of patient deaths within 28 days from enrollment
Measured: 28 days from enrollment
Anti-SARS-CoV-2 antibody titers
Anti-SARS-CoV-2 IgG antibody titers
Measured: 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
Measured: days 0, 1, 7 and 14 of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start21 Sep 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Limited enrolment (unable to achieve target sample size)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deonne Thaddeus Gauiran, University of the Philippines
- Investigators
- Deonne Thaddeus V Gauiran, MD, Principal investigator, UP Philippine General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567173
- Sponsor's protocol ID
- PHRR200824-002868
- Acronym
- Co-CLARITY
- Status last verified
- May 2022
- First submitted
- 24 Sep 2020
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04567173
- Acronym / sponsor ID
- Co-CLARITY / PHRR200824-002868
- Conditions
- Covid19
- Keywords
- COVID-19, Convalescent plasma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited enrolment (unable to achieve target sample size)
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Anti-SARS-CoV-2 convalescent plasma | Experimental | Drug: Anti-SARS-CoV-2 convalescent plasmaAbout 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 |
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
- Receipt of any blood products including pooled immunoglobulin or intravenous immunoglobulin (IVIg) in the past 30 days prior to enrolment
- Known IgA deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-SARS-CoV-2 convalescent plasmaconvalescent plasma derived from whole blood donors or standard pheresis from a volunteer who recovered from COVID-19 | Drug | Anti-SARS-CoV-2 convalescent plasma |
Primary outcome
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
12 secondary outcomes
Quick SOFA (qSOFA) score
Time frame: 28 days from enrollment
Cardiopulmonary arrest
Time frame: 28 days from enrollment
ICU mortality
Time frame: 28 days from enrollment
ICU length of stay
Time frame: 28 days from enrollment
Hospital mortality
Time frame: 28 days from enrollment
Hospital length of stay
Time frame: 28 days from enrollment
Dialysis-free days
Time frame: 28 days from enrollment
Vasopressor-free days
Time frame: 28 days from enrollment
ICU-free days
Time frame: 28 days from enrollment
28-day mortality
Time frame: 28 days from enrollment
Anti-SARS-CoV-2 antibody titers
Time frame: days 0, 1, 7 and 14 of enrollment
SARS-CoV-2 RNA by RT-PCR
Time frame: days 0, 1, 7 and 14 of enrollment
Results and safety
The study was stopped early (reason given: Limited enrolment (unable to achieve target sample size)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deonne Thaddeus V Gauiran, MD principal investigator
UP Philippine General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anti-SARS-CoV-2 convalescent plasma in people with Covid19, run by University of the Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Limited enrolment (unable to achieve target sample size)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (time frame: 28 days from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.