Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma

NCT04502472 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: Inova COVID-19 CCP
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.

Conditions

Covid-19

Outcome Measures

Primary Outcomes (2)

• Change is Clinical Status

  Change is clinical status as captured by 7-point ordinal scale to include 1. Death 2. Hospitalized, requiring mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). 7. Not Hospitalized

  Time of plasma infusion (day 0) compared to day 7

• Transfusion Related Events Due to Administration of CCP

  Number of participants with Transfusion Related Adverse Events

  Within 6 hours of infusion

Secondary Outcomes (5)

• Change is Clinical Status

  Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28

• Length of Hospital Stay

  Total Index Hospitalization

• Mechanical Ventilation

  Days 7, 14, 21, 28

• Change in Mechanical Ventilation Status

  Day 0 (date of CCP transfusion) to Day 28

• Mortality

  From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.

Study Arms (1)

Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion

EXPERIMENTAL

Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria

Biological: Convalescent plasma transfusion

Interventions

Convalescent plasma transfusion BIOLOGICAL

Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.

Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Outpatients 18 years old and older who have recovered from COVID-19:
• Have proof of Original Positive SARS-CoV-2 NAT nasopharyngeal (NP) test result
• Complete resolution of symptoms at least 14 days prior to donation
• Negative SARS-CoV-2 NAT nasopharyngeal (NP) specimen at screening visit
• Able to meet standard criteria for blood donation
• Clinically stable based on provider assessment

You may not qualify if:

• Inability to complete or contraindication to donation based on Donor History -
• Questionnaire (DHQ), FDA approved standard blood donation form
• Hb\<13.0 g/dL for males
• Hb\<12.5 g/dL for females
• History of 3 more pregnancies unless HLA antibody testing is performed and deemed acceptable by director of blood donor services (to reduce risks of transfusion Related Acute Lung Injury in recipients). The presence of any transfusion transmitted diseases is based on history or test results from blood sample collected from the donor at time of plasma collection in accordance to standard practice.
• Female subjects who are pregnant by self-report.
• Receipt of pooled immunoglobulin in past 30 days
• Patients in the Inova Health System with confirmed COVID-19 by PCR testing
• Age ≥ 13 years
• Currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome as follows:
• Severe COVID-19: (three or more of the following)
• Dyspnea
• Respiratory rate ≥ 30/min
• Blood oxygen saturation (SpO2) ≤ 94% on room air
• Partial pressure of arterial oxygen to fraction of inspired oxygen (P:F) ratio \< 300

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Related Publications (18)

• Marano G, Vaglio S, Pupella S, Facco G, Catalano L, Liumbruno GM, Grazzini G. Convalescent plasma: new evidence for an old therapeutic tool? Blood Transfus. 2016 Mar;14(2):152-7. doi: 10.2450/2015.0131-15. Epub 2015 Nov 6.

  PMID: 26674811 BACKGROUND

• 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.

  PMID: 25030060 BACKGROUND

• Maiztegui JI, Fernandez NJ, de Damilano AJ. Efficacy of immune plasma in treatment of Argentine haemorrhagic fever and association between treatment and a late neurological syndrome. Lancet. 1979 Dec 8;2(8154):1216-7. doi: 10.1016/s0140-6736(79)92335-3.

  PMID: 92624 BACKGROUND

• Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x.

  PMID: 15214887 BACKGROUND

• Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.

  PMID: 21248066 BACKGROUND

• Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.

  PMID: 26618098 BACKGROUND

• van Griensven J, Edwards T, Baize S; Ebola-Tx Consortium. Efficacy of Convalescent Plasma in Relation to Dose of Ebola Virus Antibodies. N Engl J Med. 2016 Dec 8;375(23):2307-2309. doi: 10.1056/NEJMc1609116. Epub 2016 Nov 14. No abstract available.

  PMID: 27959686 BACKGROUND

• WHO. Use of convalescent whole blood or plasma collected from patients recovered from Ebola virus disease for transfusion, as an empirical treatment during outbreaks. 2014 http://apps.who.int/iris/rest/bitstreams/604045/retrieve (accessed 3/27/2020).

  BACKGROUND

• WHO. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected 2020. https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf (accessed 3/27/20).

  BACKGROUND

• Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.

  PMID: 32113510 BACKGROUND

• Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10.

  PMID: 32150748 BACKGROUND

• Amanat F, Stadlbauer D, Strohmeier S, Nguyen THO, Chromikova V, McMahon M, Jiang K, Arunkumar GA, Jurczyszak D, Polanco J, Bermudez-Gonzalez M, Kleiner G, Aydillo T, Miorin L, Fierer DS, Lugo LA, Kojic EM, Stoever J, Liu STH, Cunningham-Rundles C, Felgner PL, Moran T, Garcia-Sastre A, Caplivski D, Cheng AC, Kedzierska K, Vapalahti O, Hepojoki JM, Simon V, Krammer F. A serological assay to detect SARS-CoV-2 seroconversion in humans. Nat Med. 2020 Jul;26(7):1033-1036. doi: 10.1038/s41591-020-0913-5. Epub 2020 May 12.

  PMID: 32398876 BACKGROUND

• Epstein J, Burnouf T. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Vox Sang. 2020 Aug;115(6):485-487. doi: 10.1111/vox.12939. Epub 2020 May 14. No abstract available.

  PMID: 32319102 BACKGROUND

• Beigel JH, Tebas P, Elie-Turenne MC, Bajwa E, Bell TE, Cairns CB, Shoham S, Deville JG, Feucht E, Feinberg J, Luke T, Raviprakash K, Danko J, O'Neil D, Metcalf JA, King K, Burgess TH, Aga E, Lane HC, Hughes MD, Davey RT; IRC002 Study Team. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study. Lancet Respir Med. 2017 Jun;5(6):500-511. doi: 10.1016/S2213-2600(17)30174-1. Epub 2017 May 15.

  PMID: 28522352 BACKGROUND

• Wang Y, Fan G, Horby P, Hayden F, Li Q, Wu Q, Zou X, Li H, Zhan Q, Wang C, Cao B; CAP-China Network. Comparative Outcomes of Adults Hospitalized With Seasonal Influenza A or B Virus Infection: Application of the 7-Category Ordinal Scale. Open Forum Infect Dis. 2019 Feb 15;6(3):ofz053. doi: 10.1093/ofid/ofz053. eCollection 2019 Mar.

  PMID: 30895200 BACKGROUND

• Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

  PMID: 8844239 BACKGROUND

• Woelfel R, Corman VM, Guggemos W, et al. Clinical presentation and virological assessment of hospitalized cases of coronavirus disease 2019 in a travel-associated transmission cluster. BMJ Yale 2020. https://doi.org/10.1101/2020.03.05.20030502

  BACKGROUND

• Pandey S, Vyas GN. Adverse effects of plasma transfusion. Transfusion. 2012 May;52 Suppl 1(Suppl 1):65S-79S. doi: 10.1111/j.1537-2995.2012.03663.x.

  PMID: 22578374 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Anne Whitney Brown, MD
• Organization: Inova Health Systems

anne.brown@inova.org

7037763067

Study Officials

• Anne Brown, M.D.

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 1 will be recruitment and enrollment of plasma donors. Phase 2 will be continued recruitment and enrollment of plasma donors, with the addition of recruitment and enrollment of plasma recipients.

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: June 6, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 10, 2022
• Results First Posted: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)