Efficacy and Safety of COVID-19 Convalescent Plasma

NCT ID: NCT04397523

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2021-05-10

Brief Summary

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

Detailed Description

There are currently no proven therapeutic options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19. Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1, MERS and H1N1 shows that convalescent plasma can be effective. Convalescent plasma will be obtained by plasmapheresis or regular whole blood donation in subjects who recovered from COVID-19 and who are otherwise eligible for donation according to the Institutional protocol. Recipients will be COVID-19 patients requiring hospitalization. A blood-type matched transfusion of convalescent plasma will be infused and recipients will be followed up.

Conditions

Convalescent Plasma; COVID-19; SARS-CoV 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hospitalized patients with SARS CoV-2 infection

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

Group Type: OTHER

anti-SARS-CoV-2 convalescent plasma

Intervention Type: BIOLOGICAL

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

Interventions

anti-SARS-CoV-2 convalescent plasma

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Blood donors:

1. Age: >18 and <60 years

2. Body weight : >55 kg

3. Confirmed previous SARS CoV-2 infection

4. Minimum 28 days after the last symptom or finishing of the isolation, or

5. 21 day without symptoms from the date of the negative SARS CoV-2 test

6. Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.

7. 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)

8. Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies

9. Individuals who meet all regular voluntary donor eligibility requirements

Patients/recipients:

1. Age: >18 years

2. Admitted to an acute care facility for the treatment of COVID-19 complications

3. Patients with severe or immediately life-threatening COVID-19, or

4. Patients who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.

5. Informed consent provided by the patient or healthcare proxy

Exclusion Criteria

Blood donors:

1. Age : <18 or >60 years

2. Female subjects who are pregnant

3. HIV1,2 hepatitis B,C or syphilis infection

4. Donors ineligible for regular voluntary blood donation

Patients/recipients:

1. Age : <18 years

2. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)

3. Patients who received in the past 30 days immunoglobulin therapy

4. Females who are pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Clinic for Infectious Diseases, North Macedonia

OTHER

Sponsor Role: collaborator

Institute for Transfusion Medicine of RNM

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rada Grubovic Rastvorceva, MD MSci PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Transfusion Medicine of RNM

Sedulla Useini, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Transfusion Medicine of RNM

Locations

Institute for Transfusion Medicine of RNM

Skopje, , North Macedonia

Countries

North Macedonia

References

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.

Reference Type: BACKGROUND

PMID: 32113510 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32219428 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 32167489 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32219429 (View on PubMed)

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

Reference Type: 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

Reference Type: 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

Reference Type: 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.

Reference Type: DERIVED

PMID: 36295001 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ITM05/2020MKD

Identifier Type: -

Identifier Source: org_study_id