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COVID-19Early Phase 1NCT04412486

COVID-19 Convalescent Plasma (CCP) Transfusion

A Early Phase 1 study testing COVID Convalescent Plasma in people with COVID-19, run by Gailen D. Marshall Jr., MD PhD 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

This research study evaluates the safety and effectiveness for the use of convalescent plasma transfusion as a treatment option for novel coronavirus SARS-CoV-2 infection (COVID-19). 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?
COVID Convalescent Plasma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteUnited States
Study dates
1 Jun 2020to 23 Mar 2023
Phase
Early Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18
  • Clinician judged serious or life threatening COVID-19 (or at significant risk to develop serious COVID) manifested by at least one of the following:
  • Laboratory confirmed diagnosis of SARS-CoV-2 infection
  • Hypoxia (PaO2/FiO2 <300, Pulse oximetry <93% at rest
  • Evidence of pulmonary infiltration
  • Respiratory failure
Show all 9Show fewer
  • Sepsis
  • Multiple organ dysfunction or failure (assessed by SOFA score)
  • Informed consent provided by the patient or legally authorized representative (LAR)

Who cannot join

  • Greater than 21 days from confirmed COVID-19 diagnosis
  • Receipt of pooled immunoglobulin transfusion in previous 28 days
  • History of prior reaction to transfused blood products
  • Currently enrolled in other drug trials that preclude investigational treatment with CoV-2 convalescent plasma transfusion

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

Other trials in United States

About this study

Official title: An Open Label Trial of Transfusion of COVID-19 Convalescent Plasma (CCP) to Patients With Moderate to Severe COVID-19

This research study evaluates the safety and effectiveness for the use of convalescent plasma transfusion as a treatment option for novel coronavirus SARS-CoV-2 infection (COVID-19). Donors who have recovered from COVID-19 with high antibody levels to the CoV-2 virus will donate plasma at a Mississippi Blood Services facility. Recipients with COIVD-19 who have severe or life threatening conditions will receive plasma from those persons who have recovered from COVID-19.

Read the detailed description

The research purpose is to evaluate the safety and clinical effectiveness of transfusing one unit of banked plasma obtained from patients who have recovered from the novel coronavirus SARS-C0V-2 infection with high titers of IgG antibody to this virus transfused into patients with severe or at high risk of progressing to severe coronavirus-induced disease (COVID-19).

The research hypothesis is that COVID-19 convalescent plasma (CCP) transfusion improves outcomes in patients with COVID-19.

The use of CCP to treat serious and life threatening COVID-19 has a sound biological as well as clinical rationale to provide virus-specific immune protection in patients unable to produce and/or maintain antiviral antibodies. This treatment protocol is designed primarily to offer a rescue therapy in patients with severe and life threatening disease and explore use in patients for whom a progression to serious disease is likely. Examining the specific antibody responses to the virus in transfused patients if/when they show signs of recovery and comparing these values with those obtained before the transfusion may provide information to design more extensive trials aimed at identifying the best patient population for future use of CCP.

Conditions
COVID-19
Being tested
COVID Convalescent Plasma
Keywords
COVID-19 Convalescent Plasma, Coronavirus, 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.

  • COVID Convalescent PlasmaBiological

    Also called CCP, COVID-19 Convalescent Plasma

    One unit of COVID Convalescent Plasma transfused on Day 0

Study groups in NCT04412486
Study groupRoleWhat they receive
Recipient of COVID-19 Convalescent Plasma (CCP) TransfusionExperimentalTransfusion of COVID-19 convalescent plasma to participants with serious or life threatening complications from COVID-19 or are at high risk to develop serious complications.
Receives: Biological: COVID Convalescent Plasma

What is being measured

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

  1. Change in PaO2/FiO2 after CCP transfusion.

    Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by PaO2/FiO2.

    Measured: 3 Days

  2. Change in pulse oximetry status after CCP transfusion.

    Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by pulse oximetry.

    Measured: 3 Days

  3. Change in aO2 after CCP transfusion.

    Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by aO2.

    Measured: 3 Days

  4. Change in respiratory rate after CCP transfusion.

    Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by respiratory rate.

    Measured: 3 Days

  5. Change in intubation status after CCP transfusion.

    Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by intubation status.

    Measured: 3 Days

Secondary outcomes (6)

  1. Change in Sequential Organ Failure Assessment (SOFA).

    Change in SOFA score pre-transfusion to Days 1, 3, 7, and 28 post-transfusion.

    Measured: Days 1, 3, 7, and 28

  2. Change in 8-point ordinal clinical deterioration scale.

    Change in 8-point ordinal clinical deterioration scale pre-transfusion to Days 1, 3, 7, and 28 post-transfusion. The 8-point ordinal scale measured by: 8-death, 7-ventilation in addition to ECMO, CRRT and/or vasopressor; 6-intubation and mechanical ventilation; 5-non-invasive mechanical ventilation or high flow oxygen 4- supplemental oxygen by mask or nasal cannula; 3- hospitalization without supplemental oxygen; 2- limitation of activities and 1- no limitation of activities, discharge from hospital.

    Measured: Days 1, 3, 7, and 28

  3. Length of ICU/hospital stay.

    Total length of stay in ICU/hospital.

    Measured: Days 1, 3, 7, and 28

  4. Development of plasma transfusion reactions.

    Presence of any signs or symptoms of plasma transfusion reactions at Days 1, 3, 7, and 28 post-transfusion.

    Measured: Days 1, 3, 7, and 28

  5. Development of immune complex disorders.

    Presence of any signs or symptoms of immune complex disorders (fever spike, urticarial lesion, arthralgias, myalgias, hematuria, non IgE-mediated anaphylaxis) at Days 1, 3, 7, and 28 post-transfusion.

    Measured: Days 1, 3, 7, and 28

  6. Change in anti CoV-2 IgM and IgG levels.

    Change in anti CoV-2 IgM and IgG levels pre-transfusion compared to levels on Days 1, 3, 7, and 28 post-transfusion.

    Measured: Days 1, 3, 7, and 28

Timeline

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

  1. First posted2 Jun 2020
  2. Study start1 Jun 2020
  3. Primary completion23 Mar 2023
  4. Study completion23 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04412486
Sponsor's protocol ID
2020-0137
Status last verified
Nov 2023
First submitted
28 May 2020
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Syal K. COVID-19: Herd immunity and convalescent plasma transfer therapy. J Med Virol. 2020 Sep;92(9):1380-1382. doi: 10.1002/jmv.25870. Epub 2020 Jul 11. No abstract available.

    PubMed 32281679

  • Xu Z, Li S, Tian S, Li H, Kong LQ. Full spectrum of COVID-19 severity still being depicted. Lancet. 2020 Mar 21;395(10228):947-948. doi: 10.1016/S0140-6736(20)30308-1. Epub 2020 Feb 14. No abstract available.

    PubMed 32066525

  • Luke TC, Kilbane EM, Jackson JL, Hoffman SL. Meta-analysis: convalescent blood products for Spanish influenza pneumonia: a future H5N1 treatment? Ann Intern Med. 2006 Oct 17;145(8):599-609. doi: 10.7326/0003-4819-145-8-200610170-00139. Epub 2006 Aug 29.

    PubMed 16940336

  • Wong SS, Yuen KY. The management of coronavirus infections with particular reference to SARS. J Antimicrob Chemother. 2008 Sep;62(3):437-41. doi: 10.1093/jac/dkn243. Epub 2008 Jun 18.

    PubMed 18565970

  • Mo Y, Fisher D. A review of treatment modalities for Middle East Respiratory Syndrome. J Antimicrob Chemother. 2016 Dec;71(12):3340-3350. doi: 10.1093/jac/dkw338. Epub 2016 Sep 1.

    PubMed 27585965

  • van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.

    PubMed 26735992

  • Ye Q, Wang B, Mao J. The pathogenesis and treatment of the ;Cytokine Storm' in COVID-19. J Infect. 2020 Jun;80(6):607-613. doi: 10.1016/j.jinf.2020.03.037. Epub 2020 Apr 10.

    PubMed 32283152

  • Jiang S, Hillyer C, Du L. Neutralizing Antibodies against SARS-CoV-2 and Other Human Coronaviruses. Trends Immunol. 2020 May;41(5):355-359. doi: 10.1016/j.it.2020.03.007. Epub 2020 Apr 2.

    PubMed 32249063

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing COVID Convalescent Plasma in people with COVID-19, run by Gailen D. Marshall Jr., MD PhD 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 9 inclusion and 4 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 29 Nov 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in PaO2/FiO2 after CCP transfusion. (time frame: 3 Days). The study lists 5 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 NCT04412486, which also lists 8 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 29 Nov 2023.

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