Efficacy and Safety of COVID-19 Convalescent Plasma

COVID-19 Clinical Trial

Official title:

Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397523
• Other study ID #: ITM05/2020MKD
• Status: Completed
• Phase: N/A
• Start date: April 30, 2020
• Est. completion date: May 10, 2021

Study information

• Verified date: December 2023
• Source: Institute for Transfusion Medicine of RNM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Convalescent Plasma
• COVID-19
• SARS-CoV 2

Intervention

Biological:
• anti-SARS-CoV-2 convalescent plasma
Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection

Locations

Country	Name	City	State
North Macedonia	Institute for Transfusion Medicine of RNM	Skopje

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Transfusion Medicine of RNM	University Clinic for Infectious Diseases, North Macedonia

Country where clinical trial is conducted

North Macedonia, 

References & Publications (8)

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

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. — View 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. — View 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

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

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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Oxygenation Support	The total number of days patients required respiratory support.	28 days after transfusion or until hospital discharge (whichever comes first)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Type of Respiratory Support	Type of supplemental oxygen support (e.g. nasal canula, high flow nasal canula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation)	28 days after transfusion or until hospital discharge (whichever comes first)
Secondary	Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery	Number of participants with different clinical outcomes including death, critical illness, limitation of activities and recovery	28 days after transfusion or until hospital discharge (whichever comes first)

External Links

•   Investigational COVID-19 Convalescent Plasma - Emergency INDs - April 03, 2020