Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Phase 2NCT04343261

Convalescent Plasma in the Treatment of COVID 19

A Phase 2 study testing Convalescent Plasma in people with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and COVID, run by Trinity Health Of New England at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), COVID, Coronavirus
What is being tested?: Convalescent Plasma
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 10 Apr 2020to 13 Aug 2020
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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All genders
Age > 18 yrs and < 90 yrs
Must have laboratory confirmed COVID-19
Must provide informed consent
Must have severe or immediately life-threatening COVID-19,
Severe disease is defined as:

Show all 15Show fewer

dyspnea,
respiratory frequency ≥ 30/min,
blood oxygen saturation ≤ 93%,
partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
lung infiltrates > 50% within 24 to 48 hours
Life-threatening disease is defined as:
respiratory failure,
septic shock
multiple organ dysfunction or failure

Who cannot join

No gender exclusion
Age < 18 yrs and > 90 yrs
COVID-19 negative

Trial locations and contacts

1 site in 1 country.

United States1 site

Trinity Health Of New England
Hartford, Connecticut, 06105

Other trials in United States

About this study

Read the detailed description

The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19.

1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19.

Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), COVID, Coronavirus
Being tested: Convalescent Plasma
Keywords: SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma
Medical subject headings: Coronavirus Infections, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Convalescent PlasmaBiological
treatment with 2 Units of convalescent plasma

Study groups in NCT04343261
Study group	Role	What they receive
COVID-19 patients treated with convalescent plasma	Experimental	Severely ill COVID-19 patients treated with convalescent plasma Receives: Biological: Convalescent Plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

Mortality
Mortality within 28 days
Measured: Up to 28 days
Viral Load
Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry.
The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).
Measured: Day 0, Day 3, Day 5, and Day 7
Serum Antibody Titers
Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is > or = 1.0 arbitrary units/mL [AU/mL] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)
Measured: Day 0, Day 3, Day 5, and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 202013 Aug 2020

First posted13 Apr 2020
Study start10 Apr 2020
Primary completion23 Jul 2020
Study completion13 Aug 2020

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.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Studies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04343261
Sponsor's protocol ID: SFH-20-23
Status last verified: Sep 2020
First submitted: 8 Apr 2020
Last updated: 24 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Dulipsingh L, Ibrahim D, Schaefer EJ, Crowell R, Diffenderfer MR, Williams K, Lima C, McKenzie J, Cook L, Puff J, Onoroski M, Wakefield DB, Eadie RJ, Kleiboeker SB, Nabors P, Hussain SA. SARS-CoV-2 serology and virology trends in donors and recipients of convalescent plasma. Transfus Apher Sci. 2020 Dec;59(6):102922. doi: 10.1016/j.transci.2020.102922. Epub 2020 Aug 25.
PubMed 32883593
Ibrahim D, Dulipsingh L, Zapatka L, Eadie R, Crowell R, Williams K, Wakefield DB, Cook L, Puff J, Hussain SA. Factors Associated with Good Patient Outcomes Following Convalescent Plasma in COVID-19: A Prospective Phase II Clinical Trial. Infect Dis Ther. 2020 Dec;9(4):913-926. doi: 10.1007/s40121-020-00341-2. Epub 2020 Sep 20.
PubMed 32951151
Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.
PubMed 37162745
Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.
PubMed 36734509
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
PubMed 34013969
Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.
PubMed 33044747

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Convalescent Plasma in the Treatment of COVID 19
ClinicalTrials.gov ID: NCT04343261
Acronym / sponsor ID: SFH-20-23
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), COVID, Coronavirus
Keywords: SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Trinity Health Of New EnglandUniversity, hospital or other
Study start: 10 Apr 2020 (actual)
Primary completion: 23 Jul 2020 (actual)
Study completion: 13 Aug 2020 (actual)
First posted: 13 Apr 2020 (actual)
Results: Posted 17 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19.

1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19.

Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
COVID-19 patients treated with convalescent plasma	Experimental	Biological: Convalescent PlasmaSeverely ill COVID-19 patients treated with convalescent plasma

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

All genders
Age > 18 yrs and < 90 yrs
Must have laboratory confirmed COVID-19
Must provide informed consent
Must have severe or immediately life-threatening COVID-19,

Key exclusion criteria (3 listed)

No gender exclusion
Age < 18 yrs and > 90 yrs
COVID-19 negative

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 Plasmatreatment with 2 Units of convalescent plasma	Biological	COVID-19 patients treated with convalescent plasma

Primary outcome

Mortality
Time frame: Up to 28 days
Mortality within 28 days
Viral Load
Time frame: Day 0, Day 3, Day 5, and Day 7
Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).
Serum Antibody Titers
Time frame: Day 0, Day 3, Day 5, and Day 7
Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is > or = 1.0 arbitrary units/mL [AU/mL] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)

Results and safety

Results posted to the registry on 17 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COVID-19 Patients Treated With Convalescent Plasma	48	40

Primary outcome: Mortality

Time frame: Up to 28 days. Count of participants. Unit: Participants

Measure	COVID-19 Patients Treated With Convalescent Plasma n = 41
Value	19

Population analysed: 48 patients with severe or life threatening disease with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection enrolled in the study. 7 patients were excluded from analysis due to receiving plasma with insufficient antibodies.

Primary outcome: Viral Load

Time frame: Day 0, Day 3, Day 5, and Day 7. Median (Full Range). Unit: copies per mL

Measure	COVID-19 Patients Treated With Convalescent Plasma n = 35
Detectable Viral Load Day 0	3524 (868 to 8315)
Detectable Viral Load Day 3	2033 (243 to 6386)
Detectable Viral Load Day 5	315 (214 to 4162)
Detectable Viral Load Day 7	494 (102 to 1292)

Population analysed: Plasma viral load data was available for 35 out of 41 convalescent plasma recipients on day 0. 22 patients out of 35 had non-detectable levels at Day 0; 25 patients out of 34 had non-detectable levels on Day 3; 20 patients out of 27 had non-detectable levels on Day 5; 20 patients out of 24 had non-detectable levels on Day 7.

Primary outcome: Serum Antibody Titers

Time frame: Day 0, Day 3, Day 5, and Day 7. Median (Full Range). Unit: arbitrary units/mL (AU/mL)

Measure	COVID-19 Patients Treated With Convalescent Plasma n = 39
SARS-CoV-2 Antibodies Day 0	18.5 (1.0 to 75.0)
SARS-CoV-2 Antibodies Day 3	37.2 (4.5 to 74.6)
SARS-CoV-2 Antibodies Day 5	47.4 (6.7 to 80.7)
SARS-CoV-2 Antibodies Day 7	55.2 (10.3 to 96.9)

Population analysed: 39 out of 41 patients had blood collected on day 0 (pre-transfusion), and on post-transfusion day 3 (n=36), 5 (n=30), and 7 (n=24) and serum antibody titers was assessed at each time point.

Adverse events

Time frame: Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COVID-19 Patients Treated With Convalescent Plasma	8 of 48 (16.7%)	8 of 48 (16.7%)	22 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32883593Dulipsingh L, Ibrahim D, Schaefer EJ, Crowell R, Diffenderfer MR, Williams K, Lima C, McKenzie J, Cook L, Puff J, Onoroski M, Wakefield DB, Eadie RJ, Kleiboeker SB, Nabors P, Hussain SA. SARS-CoV-2 serology and virology trends in donors and recipients of convalescent plasma. Transfus Apher Sci. 2020 Dec;59(6):102922. doi: 10.1016/j.transci.2020.102922. Epub 2020 Aug 25.
Results publication: PubMed 32951151Ibrahim D, Dulipsingh L, Zapatka L, Eadie R, Crowell R, Williams K, Wakefield DB, Cook L, Puff J, Hussain SA. Factors Associated with Good Patient Outcomes Following Convalescent Plasma in COVID-19: A Prospective Phase II Clinical Trial. Infect Dis Ther. 2020 Dec;9(4):913-926. doi: 10.1007/s40121-020-00341-2. Epub 2020 Sep 20.
Derived from this study: PubMed 37162745Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.
Derived from this study: PubMed 36734509Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.
Derived from this study: PubMed 34013969Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Derived from this study: PubMed 33044747Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.
Individual participant dataSharing planned: No

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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.

Latha Dulipsingh, MD principal investigator

Saint Francis Hospital and Medical Centerr/Trinity Health Of New England

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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and COVID, run by Trinity Health Of New England 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 15 inclusion and 3 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: finished, as of the sponsor's last update on 24 Sep 2020. 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 17 Sep 2020). 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?

Mortality (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04343261, which also lists 6 linked publications.

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 Sep 2020.