COVID-19Phase 2NCT04456413

Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection

A Phase 2 study testing Convalescent Plasma in people with COVID-19, run by Hackensack Meridian Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Convalescent Plasma
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 6 Nov 2020to 4 May 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

Donor Eligibility Criteria:

Age 18-60
A history of a positive nasopharyngeal swab for COVID-19 or a history of positive antibody titer test.
At least 14 days from resolution of COVID-19-associated symptoms including fevers.
A negative nasopharyngeal swab (or similar test) for COVID-19
anti-SARS-CoV2 titers >1:500
Adequate venous access for apheresis
Meets donor eligibility criteria in accordance to Hackensack University Medical Center (HUMC) Collection Facility at the John Theurer Cancer Center (JTCC) if collecting at the JTCC, and all regulatory agencies as describes in SOP 800 01.
Required testing of the donor and product must be performed in accordance to FDA regulations (21 CFR 610.40), and the donation must be found suitable (21 CFR 630.30)

Recipient Eligibility Criteria:

Patient age >30 years old, newly diagnosed with a COVID-19 infection with onset of first symptoms < 96 hours.
And least one other high-risk feature:

Age > 65
BMI 30 or above
Hypertension, defined as SBP above 140 or DBP above 90, or requiring medication for control.
Coronary artery disease (history, not ECG changes only)
Congestive heart failure
Peripheral vascular disease (includes aortic aneurysm >= 6 cm)
Cerebrovascular disease (history of CVA or TIA)
Dementia
Chronic pulmonary disease
Liver disease (such as portal hypertension, chronic hepatitis)
Diabetes (excludes diet-controlled alone)
Moderate or severe renal disease defined as having a GFR < 60 mL/min
Cancer (exclude if > 5 year in remission)
AIDS (not just HIV positive)

Recipient exclusion criteria:

History of severe transfusion reaction to plasma products
Need for oxygen supplementation
Positive test for COVID-19 antibodies
Chemotherapy-induced neutropenia (ANC < 0.5 x 103/mcL)
Immunosuppressive medications except for prednisone (or steroid equivalent) > 10 mg daily.
Performance status < 50 by KPS
Pneumonia by radiographic evaluation

Trial locations and contacts

1 site in 1 country.

United States1 site

Hackensack University Medical Center
Hackensack, New Jersey, 07601

Other trials in United States

About this study

Official title: Phase II Randomized Study of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects With Early COVID-19 Infection

This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.
Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.
Subjects will be randomized to receiving convalescent plasma or best supportive care.
Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

Read the detailed description

Overall study design

This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.
Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.
Subjects will be randomized to receiving convalescent plasma or best supportive care.
Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

A total of 306 subjects will be recruited, 153 for each arm. If a patient in the best supportive care arm requires hospitalization, the patient will be eligible to receive convalescent plasma if requested and/or deemed medically appropriate by the admitting physician.

Overall study duration

The study begins when the first subject (donor or recipient) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient).
The expected duration of the study is approximately 12 months.

Conditions: COVID-19
Being tested: Convalescent Plasma, Best Supportive Care
Keywords: Coronavirus, Covid19, SARS-CoV-2
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

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

Convalescent PlasmaBiological
Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Best Supportive CareOther
Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.

Study groups in NCT04456413
Study group	Role	What they receive
Convalescent Plasma	Experimental	Fresh or frozen plasma will be infused one time to patients Receives: Biological: Convalescent Plasma
Best Supportive Care	Active comparator	Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. Receives: Other: Best Supportive Care

What is being measured

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

Hospitalization Rate
The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.
Measured: 10 Days

Secondary outcomes (8)

Time to Symptoms Resolution
The time to symptoms resolution is defined as the time in days from therapies initiation to the first documented symptoms resolution as assessed by a local site. Patients whose symptoms are not resolved, or result in death, or lost follow-up on the designed follow-up date, will be censored on that date.
Measured: 2 Months
Overall Survival Rate
Overall survival (OS) will be defined as Rate of death
Measured: 2 Months
Rate of Virologic Clearance by Nasopharyngeal Swab at 2 Weeks
Measured: 2 Weeks
Rate of Nasopharyngeal Swab Positivity in Donors
Measured: 2 Months
Rate of Donor Titers Level
Rate of Donor Titer Levels >1:1000
Measured: 2 Months
Impact of Donor Titers Level on Efficacy
Measured: 2 Months
Patients' Anti-SARS-CoV2 Titer Assessment Pre-infusion for the Treatment Group, at 2 Weeks , 4 Weeks and 2 Months.
Measured: Prior to treatment, 2 Weeks, 4 Weeks, and 2 Months
Rate of Virologic Clearance by Nasopharyngeal Swab at 4 Weeks
Measured: 4 Weeks

Timeline

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

6 Nov 20204 May 2021

First posted2 Jul 2020
Study start6 Nov 2020
Primary completion29 Apr 2021
Study completion4 May 2021

Why it stopped: Lack of accrual

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 (22)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04456413
Sponsor's protocol ID: Pro2020-0542
Status last verified: Sep 2023
First submitted: 30 Jun 2020
Last updated: 10 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
PubMed 32192578
Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available.
PubMed 7985997
Casadevall A, Scharff MD. Return to the past: the case for antibody-based therapies in infectious diseases. Clin Infect Dis. 1995 Jul;21(1):150-61. doi: 10.1093/clinids/21.1.150.
PubMed 7578724
Casadevall A, Pirofski LA. Antibody-mediated regulation of cellular immunity and the inflammatory response. Trends Immunol. 2003 Sep;24(9):474-8. doi: 10.1016/s1471-4906(03)00228-x. No abstract available.
PubMed 12967670
Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974.
PubMed 15372080
Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
PubMed 32167489
Zhang JS, Chen JT, Liu YX, Zhang ZS, Gao H, Liu Y, Wang X, Ning Y, Liu YF, Gao Q, Xu JG, Qin C, Dong XP, Yin WD. A serological survey on neutralizing antibody titer of SARS convalescent sera. J Med Virol. 2005 Oct;77(2):147-50. doi: 10.1002/jmv.20431.
PubMed 16121363
Sahr F, Ansumana R, Massaquoi TA, Idriss BR, Sesay FR, Lamin JM, Baker S, Nicol S, Conton B, Johnson W, Abiri OT, Kargbo O, Kamara P, Goba A, Russell JB, Gevao SM. Evaluation of convalescent whole blood for treating Ebola Virus Disease in Freetown, Sierra Leone. J Infect. 2017 Mar;74(3):302-309. doi: 10.1016/j.jinf.2016.11.009. Epub 2016 Nov 17.
PubMed 27867062
Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
PubMed 15616839
Yeh KM, Chiueh TS, Siu LK, Lin JC, Chan PK, Peng MY, Wan HL, Chen JH, Hu BS, Perng CL, Lu JJ, Chang FY. Experience of using convalescent plasma for severe acute respiratory syndrome among healthcare workers in a Taiwan hospital. J Antimicrob Chemother. 2005 Nov;56(5):919-22. doi: 10.1093/jac/dki346. Epub 2005 Sep 23.
PubMed 16183666
Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Muller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.
PubMed 29923831
Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164.
PubMed 27532807
Gunn BM, Yu WH, Karim MM, Brannan JM, Herbert AS, Wec AZ, Halfmann PJ, Fusco ML, Schendel SL, Gangavarapu K, Krause T, Qiu X, He S, Das J, Suscovich TJ, Lai J, Chandran K, Zeitlin L, Crowe JE Jr, Lauffenburger D, Kawaoka Y, Kobinger GP, Andersen KG, Dye JM, Saphire EO, Alter G. A Role for Fc Function in Therapeutic Monoclonal Antibody-Mediated Protection against Ebola Virus. Cell Host Microbe. 2018 Aug 8;24(2):221-233.e5. doi: 10.1016/j.chom.2018.07.009.
PubMed 30092199
Wan Y, Shang J, Sun S, Tai W, Chen J, Geng Q, He L, Chen Y, Wu J, Shi Z, Zhou Y, Du L, Li F. Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry. J Virol. 2020 Feb 14;94(5):e02015-19. doi: 10.1128/JVI.02015-19. Print 2020 Feb 14.
PubMed 31826992
Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.
PubMed 25030060

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?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Randomized Study of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects With Early COVID-19 Infection
ClinicalTrials.gov ID: NCT04456413
Acronym / sponsor ID: Pro2020-0542
Conditions: COVID-19
Keywords: Coronavirus, Covid19, SARS-CoV-2
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of accrual
Enrolment: 21 participants (actual)
Lead sponsor: Hackensack Meridian HealthUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: 6 Nov 2020 (actual)
Primary completion: 29 Apr 2021 (actual)
Study completion: 4 May 2021 (actual)
First posted: 2 Jul 2020 (actual)
Results: Posted 10 Feb 2023

Clinical summary

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

This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.
Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.
Subjects will be randomized to receiving convalescent plasma or best supportive care.
Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

Detailed description

Overall study design

This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.
Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.
Subjects will be randomized to receiving convalescent plasma or best supportive care.
Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

Overall study duration

The study begins when the first subject (donor or recipient) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient).
The expected duration of the study is approximately 12 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Convalescent Plasma	Experimental	Biological: Convalescent PlasmaFresh or frozen plasma will be infused one time to patients
Best Supportive Care	Active comparator	Other: Best Supportive CarePatients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.

Who may qualify

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

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 PlasmaFresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection	Biological	Convalescent Plasma
Best Supportive CarePatients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.	Other	Best Supportive Care

Primary outcome

Hospitalization Rate
Time frame: 10 Days
The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.

8 secondary outcomes

Time to Symptoms Resolution
Time frame: 2 Months
Overall Survival Rate
Time frame: 2 Months
Rate of Virologic Clearance by Nasopharyngeal Swab at 2 Weeks
Time frame: 2 Weeks
Rate of Nasopharyngeal Swab Positivity in Donors
Time frame: 2 Months
Rate of Donor Titers Level
Time frame: 2 Months
Impact of Donor Titers Level on Efficacy
Time frame: 2 Months
Patients' Anti-SARS-CoV2 Titer Assessment Pre-infusion for the Treatment Group, at 2 Weeks , 4 Weeks and 2 Months.
Time frame: Prior to treatment, 2 Weeks, 4 Weeks, and 2 Months
Rate of Virologic Clearance by Nasopharyngeal Swab at 4 Weeks
Time frame: 4 Weeks

Results and safety

Results posted to the registry on 10 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Convalescent Plasma	10	10
Best Supportive Care	11	11

Primary outcome: Hospitalization Rate

Time frame: 10 Days. Count of participants. Unit: Participants

Measure	Convalescent Plasma n = 10	Best Supportive Care n = 11
Value	1	3

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Convalescent Plasma	1 of 10 (10%)	1 of 10 (10%)	0 of 10
Best Supportive Care	3 of 11 (27.3%)	0 of 11 (0%)	0 of 11

Limitations and caveats (from the sponsor): The convalescent plasma technology has been replaced by antivirals and monoclonal antibodies. Therefore, the study was not able to accrue successfully and was subsequently terminated. All available data (due to the lack of a formal analysis) is reported here.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32192578Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
Background: PubMed 7985997Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available.
Background: PubMed 7578724Casadevall A, Scharff MD. Return to the past: the case for antibody-based therapies in infectious diseases. Clin Infect Dis. 1995 Jul;21(1):150-61. doi: 10.1093/clinids/21.1.150.
Background: PubMed 12967670Casadevall A, Pirofski LA. Antibody-mediated regulation of cellular immunity and the inflammatory response. Trends Immunol. 2003 Sep;24(9):474-8. doi: 10.1016/s1471-4906(03)00228-x. No abstract available.
Background: PubMed 15372080Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974.
Background: PubMed 32167489Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
Background: PubMed 16121363Zhang JS, Chen JT, Liu YX, Zhang ZS, Gao H, Liu Y, Wang X, Ning Y, Liu YF, Gao Q, Xu JG, Qin C, Dong XP, Yin WD. A serological survey on neutralizing antibody titer of SARS convalescent sera. J Med Virol. 2005 Oct;77(2):147-50. doi: 10.1002/jmv.20431.
Background: PubMed 27867062Sahr F, Ansumana R, Massaquoi TA, Idriss BR, Sesay FR, Lamin JM, Baker S, Nicol S, Conton B, Johnson W, Abiri OT, Kargbo O, Kamara P, Goba A, Russell JB, Gevao SM. Evaluation of convalescent whole blood for treating Ebola Virus Disease in Freetown, Sierra Leone. J Infect. 2017 Mar;74(3):302-309. doi: 10.1016/j.jinf.2016.11.009. Epub 2016 Nov 17.
Background: PubMed 15616839Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
Background: PubMed 16183666Yeh KM, Chiueh TS, Siu LK, Lin JC, Chan PK, Peng MY, Wan HL, Chen JH, Hu BS, Perng CL, Lu JJ, Chang FY. Experience of using convalescent plasma for severe acute respiratory syndrome among healthcare workers in a Taiwan hospital. J Antimicrob Chemother. 2005 Nov;56(5):919-22. doi: 10.1093/jac/dki346. Epub 2005 Sep 23.
Background: PubMed 29923831Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Muller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.
Background: PubMed 27532807Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164.
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.

Michele L Donato, MD principal investigator

Hackensack Meridian Health

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-19, run by Hackensack Meridian Health 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?

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 10 Oct 2023. 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 10 Feb 2023). 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?

Hospitalization Rate (time frame: 10 Days). 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 NCT04456413, which also lists 22 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 10 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.