COVIDPhase 2NCT04408040
Use of Convalescent Plasma for COVID-19
A Phase 2 study testing Convalescent Plasma in people with COVID, run by Northside Hospital, Inc. at 1 site in United States.
Trial summary
The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- What is being tested?
- Convalescent Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2020to 14 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented COVID-19 infection by nasal pharyngeal sampling
- COVID-19 disease falling into one of the following groups:
- Critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure
- Severe disease: tachypnea >/=30 per min, O2 sats </=93% at rest, PaO2/FiO2 index </=300mmHg
- High Risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate to severe asthma history, severe COPD, morbid obesity (BMI >/=40, age >/=65 years
- Health Care Providers: health care providers at risk to exposure to COVID-19 infection or those with mild to non-severe disease
Who cannot join
- History of IgA deficiency
- History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Convalescent Plasma Collected From Donors Recovered From COVID-19 Virus Disease for Transfusion, as an Empirical and Preemptive Treatment During Viral Pandemic Outbreak
The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.
- Conditions
- COVID
- Being tested
- Convalescent Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent PlasmaBiological
200-425mL convalescent plasma donated by patients previously positive for COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Critical Patients | Other | Not described Receives: Biological: Convalescent Plasma |
| Severe Patients | Other | Not described Receives: Biological: Convalescent Plasma |
| High Risk | Other | Not described Receives: Biological: Convalescent Plasma |
| Health Care Providers | Other | Not described Receives: Biological: Convalescent Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection
Number of patients who survived the covid infection after treatment on study.
Measured: 30 days after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start14 Jul 2020
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
Why it stopped: New information regarding use of plasma in covid + patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVIDStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northside Hospital, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kent Holland, MD, Principal investigator, Northside Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408040
- Sponsor's protocol ID
- NSH 1281
- Status last verified
- Oct 2022
- First submitted
- 15 May 2020
- Last updated
- 14 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Convalescent Plasma Collected From Donors Recovered From COVID-19 Virus Disease for Transfusion, as an Empirical and Preemptive Treatment During Viral Pandemic Outbreak
- ClinicalTrials.gov ID
- NCT04408040
- Acronym / sponsor ID
- NSH 1281
- Conditions
- COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New information regarding use of plasma in covid + patients
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Northside Hospital, Inc.University, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Critical Patients | Other | Biological: Convalescent Plasma |
| Severe Patients | Other | Biological: Convalescent Plasma |
| High Risk | Other | Biological: Convalescent Plasma |
| Health Care Providers | Other | Biological: Convalescent Plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented COVID-19 infection by nasal pharyngeal sampling
- COVID-19 disease falling into one of the following groups:
- Critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure
- Severe disease: tachypnea >/=30 per min, O2 sats </=93% at rest, PaO2/FiO2 index </=300mmHg
- High Risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate to severe asthma history, severe COPD, morbid obesity (BMI >/=40, age >/=65 years
Key exclusion criteria (2 listed)
- History of IgA deficiency
- History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy
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 |
|---|---|---|
| Convalescent Plasma200-425mL convalescent plasma donated by patients previously positive for COVID-19 | Biological | Critical Patients, Health Care Providers, High Risk, Severe Patients |
Primary outcome
Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection
Time frame: 30 days after initial treatment
Number of patients who survived the covid infection after treatment on study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kent Holland, MD principal investigator
Northside 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 study testing Convalescent Plasma in people with COVID, run by Northside Hospital, Inc. at 1 site in United States.
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 6 inclusion and 2 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 14 Nov 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 United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection (time frame: 30 days after initial treatment). 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 14 Nov 2022.