Efficacy and Safety of COVID-19 Convalescent Plasma

NCT04397523 | Completed Results DMC

• 1 other identifier: ITM05/2020MKD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection

Conditions

Convalescent Plasma; COVID-19; SARS-CoV 2

Keywords

COVID-19; anti SARS-CoV-2 convalescent plasma; COVID-19 convalescent plasma

Outcome Measures

Primary Outcomes (5)

• Duration of Oxygenation Support

  The total number of days patients required respiratory support.

  28 days after transfusion or until hospital discharge (whichever comes first)

• Hospital Length of Stay (LOS)

  Total number of days patients were admitted to the hospital after convalescent plasma transfusion.

  28 days after transfusion or until hospital discharge (whichever comes first)

• ICU Admission

  Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion.

  28 days after transfusion or until hospital discharge (whichever comes first)

• Number of Participants With Oxygenation Free Days

  Number of participants without oxygenation support after receiving convalescent plasma

  28 days after transfusion or until hospital discharge (whichever comes first)

• Number of Participants With Serious Adverse Events

  Number of participants with serious adverse events during the study protocol

  28 days after transfusion or until hospital discharge (whichever comes first)

Secondary Outcomes (2)

• Type of Respiratory Support

  28 days after transfusion or until hospital discharge (whichever comes first)

• Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery

  28 days after transfusion or until hospital discharge (whichever comes first)

Study Arms (1)

Hospitalized patients with SARS CoV-2 infection

OTHER

Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma

Biological: anti-SARS-CoV-2 convalescent plasma

Interventions

anti-SARS-CoV-2 convalescent plasma BIOLOGICAL

Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection

Hospitalized patients with SARS CoV-2 infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Blood donors:
• Age: \>18 and \<60 years
• Body weight : \>55 kg
• Confirmed previous SARS CoV-2 infection
• Minimum 28 days after the last symptom or finishing of the isolation, or
• day without symptoms from the date of the negative SARS CoV-2 test
• Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
• Concentration of COVID-19 IgG antibodies more than 5 AU/ml (Because measurement of neutralizing antibody titers is not available now, storing of retention sample from the convalescent plasma donation is performed for determining antibody titers at a later date)
• Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
• Individuals who meet all regular voluntary donor eligibility requirements
• Patients/recipients:
• Age: \>18 years
• Admitted to an acute care facility for the treatment of COVID-19 complications
• Patients with severe or immediately life-threatening COVID-19, or
• Patients who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.

You may not qualify if:

• Blood donors:
• Age : \<18 or \>60 years
• Female subjects who are pregnant
• HIV1,2 hepatitis B,C or syphilis infection
• Donors ineligible for regular voluntary blood donation
• Patients/recipients:
• Age : \<18 years
• Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
• Patients who received in the past 30 days immunoglobulin therapy
• Females who are pregnant or breastfeeding

Sponsors & Collaborators

• Institute for Transfusion Medicine of RNM: lead
• University Clinic for Infectious Diseases, North Macedonia: collaborator

Study Sites (1)

Institute for Transfusion Medicine of RNM

Skopje, 1000, North Macedonia

Location

Related Publications (9)

• 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

• Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.

  PMID: 32219428 BACKGROUND

• Huaxia, (2020). 'China puts 245 COVID-19 patients on convalescent plasma therapy', Xinhua.net, 2 February. Available at: http://www.xinhuanet.com/english/2020-02/28/c_138828177.htm

  BACKGROUND

• 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.

  PMID: 32167489 BACKGROUND

• Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA. 2020 Apr 28;323(16):1561-1562. doi: 10.1001/jama.2020.4940. No abstract available.

  PMID: 32219429 BACKGROUND

• https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-deviceexemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds Accessed on March 30,2020

  BACKGROUND

• Guidance on collection, testing, processing, storage, distribution and monitored use. An EU programme of COVID-19 convalescent plasma collection and transfusion. EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY, 08 April, 2020

  BACKGROUND

• AABB's CCP Collection Protocol - Donor Eligibility, Processing, Labeling and Distribution, 03 April, 2020 http://www.aabb.org/advocacy/regulatorygovernment/Documents/COVID-19-Convalescent-Plasma-Collection.pdf

  BACKGROUND

• Grubovic Rastvorceva RM, Useini S, Stevanovic M, Demiri I, Petkovic E, Franchini M, Focosi D. Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients-An Open-Label Phase II Clinical Trial. Life (Basel). 2022 Oct 9;12(10):1565. doi: 10.3390/life12101565.

  PMID: 36295001 DERIVED

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: Assoc. Prof. Dr. Rada M. Grubovic Rastvorceva, MD MSci PhD, CMO
• Organization: Institute for Transfusion Medicine of RNM

drgrubovic@gmail.com

+38923226923

Study Officials

• Rada Grubovic Rastvorceva, MD MSci PhD

  Institute for Transfusion Medicine of RNM

  PRINCIPAL INVESTIGATOR

• Sedulla Useini, MD

  Institute for Transfusion Medicine of RNM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 21, 2020
• Study Start: April 30, 2020
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: May 28, 2024
• Results First Posted: May 28, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Since the publication of results for the next 5 years
• Access Criteria: Interested researchers should write to the principal investigators of this trial explaining why they need this data

Locations

NO (1)