Clinical trial NCT04397523: Efficacy and Safety of COVID-19 Convalescent Plasma
Official title: Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Convalescent Plasma
COVID-19
SARS-CoV 2
Keywords: COVID-19
anti SARS-CoV-2 convalescent plasma
COVID-19 convalescent plasma
Lead sponsor: Institute for Transfusion Medicine of RNM
Sponsor class: OTHER_GOV
Collaborators: name: University Clinic for Infectious Diseases, North Macedonia
First posted: 2020-05-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Duration of Oxygenation Support
timeFrame: 28 days after transfusion or until hospital discharge (whichever comes first)
measure: Hospital Length of Stay (LOS)
timeFrame: 28 days after transfusion or until hospital discharge (whichever comes first)
measure: ICU Admission
timeFrame: 28 days after transfusion or until hospital discharge (whichever comes first)
measure: Number of Participants With Oxygenation Free Days
timeFrame: 28 days after transfusion or until hospital discharge (whichever comes first)
measure: Number of Participants With Serious Adverse Events
timeFrame: 28 days after transfusion or until hospital discharge (whichever comes first)
Secondary outcomes:
measure: Type of Respiratory Support
timeFrame: 28 days after transfusion or until hospital discharge (whichever comes first)
measure: Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery
timeFrame: 28 days after transfusion or until hospital discharge (whichever comes first)
Other outcomes:
Locations:
city: Skopje
country: North Macedonia
facility: Institute for Transfusion Medicine of RNM
Study officials:
affiliation: Institute for Transfusion Medicine of RNM
name: Rada Grubovic Rastvorceva, MD MSci PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Transfusion Medicine of RNM
name: Sedulla Useini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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
citation: 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
citation: 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
citation: 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.