Convalescent PlasmaNCT04397523

Efficacy and Safety of COVID-19 Convalescent Plasma

A study testing anti-SARS-CoV-2 convalescent plasma in people with Convalescent Plasma and COVID-19, run by Institute for Transfusion Medicine of RNM at 1 site in North Macedonia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Convalescent Plasma, COVID-19, SARS-CoV 2
What is being tested?: anti-SARS-CoV-2 convalescent plasma
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteNorth Macedonia
Study dates: 30 Apr 2020to 10 May 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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.
Informed consent provided by the patient or healthcare proxy

Who cannot join

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:

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

North Macedonia1 site

Institute for Transfusion Medicine of RNM
Skopje, 1000

Other trials in North Macedonia

About this study

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

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

Read the 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
Being tested: anti-SARS-CoV-2 convalescent plasma
Keywords: COVID-19, anti SARS-CoV-2 convalescent plasma, COVID-19 convalescent plasma
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04397523
Study group	Role	What they receive
Hospitalized patients with SARS CoV-2 infection	Other	Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma Receives: Biological: anti-SARS-CoV-2 convalescent plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Oxygenation Support
The total number of days patients required respiratory support.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 28 days after transfusion or until hospital discharge (whichever comes first)

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 202010 May 2021

First posted21 May 2020
Study start30 Apr 2020
Primary completion10 May 2021
Study completion10 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Convalescent PlasmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04397523
Sponsor's protocol ID: ITM05/2020MKD
Status last verified: Dec 2023
First submitted: 20 May 2020
Last updated: 28 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD will be shared on request to other clinical researchers involved in similar trials or meta-analysis

Publications

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.
PubMed 32113510
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.
PubMed 32219428
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
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.
PubMed 32167489
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.
PubMed 32219429
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
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
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
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.
PubMed 36295001

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
RecruitingObservational study
Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
Covid19
RecruitingPhase 2
Convalescent Plasma as a Possible Treatment for COVID-19
COVID-19

All Convalescent Plasma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety
ClinicalTrials.gov ID: NCT04397523
Acronym / sponsor ID: ITM05/2020MKD
Conditions: Convalescent Plasma, COVID-19, SARS-CoV 2
Keywords: COVID-19, anti SARS-CoV-2 convalescent plasma, COVID-19 convalescent plasma
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Institute for Transfusion Medicine of RNMOther government
Collaborators: University Clinic for Infectious Diseases, North Macedonia
Study start: 30 Apr 2020 (actual)
Primary completion: 10 May 2021 (actual)
Study completion: 10 May 2021 (actual)
First posted: 21 May 2020 (actual)
Results: Posted 28 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Hospitalized patients with SARS CoV-2 infection	Other	Biological: anti-SARS-CoV-2 convalescent plasmaHospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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

Key exclusion criteria (10 listed)

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
Age : <18 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
anti-SARS-CoV-2 convalescent plasmaAdministration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection	Biological	Hospitalized patients with SARS CoV-2 infection

Primary outcome

Duration of Oxygenation Support
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
The total number of days patients required respiratory support.
Hospital Length of Stay (LOS)
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Total number of days patients were admitted to the hospital after convalescent plasma transfusion.
ICU Admission
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion.
Number of Participants With Oxygenation Free Days
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Number of participants without oxygenation support after receiving convalescent plasma
Number of Participants With Serious Adverse Events
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Number of participants with serious adverse events during the study protocol

2 secondary outcomes

Type of Respiratory Support
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)

Results and safety

Results posted to the registry on 28 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hospitalized Patients With SARS CoV-2 Infection	200	189

Primary outcome: Duration of Oxygenation Support

Time frame: 28 days after transfusion or until hospital discharge (whichever comes first). Mean (Standard Deviation). Unit: days

Measure	Hospitalized Patients With SARS CoV-2 Infection n = 124
Value	7.4 (5.2)

Population analysed: This is the number of patients that required respiratory support before CCP transfusion

Primary outcome: Hospital Length of Stay (LOS)

Time frame: 28 days after transfusion or until hospital discharge (whichever comes first). Mean (Standard Deviation). Unit: days

Measure	Hospitalized Patients With SARS CoV-2 Infection n = 189
total investigated group	11.0 (5.3)
patients with WHO disease progression score 3, which are not on oxygen support	8.6 (2.7)
patients with WHO score 4, which are on oxygen support with nasal canila or oxygen mask	11.1 (4.7)
patients with WHO score 5, which are on oxygen support with noninvasive ventilation	13.6 (6.7)

Hospitalized Patients With SARS CoV-2 Infection: p = 0.05, ANOVA

Population analysed: The bellow are shown subgroups of participants according to the WHO disease progression scores 3,4 and 5, which all together comprises total investigated group of 189 participants.

Primary outcome: ICU Admission

Time frame: 28 days after transfusion or until hospital discharge (whichever comes first). Count of participants. Unit: Participants

Measure	Hospitalized Patients With SARS CoV-2 Infection n = 189
Value	1

Primary outcome: Number of Participants With Oxygenation Free Days

Time frame: 28 days after transfusion or until hospital discharge (whichever comes first). Count of participants. Unit: Participants

Measure	Hospitalized Patients With SARS CoV-2 Infection n = 189
Participants with oxygenation free days before CCP transfusion	65
Participants with oxygenation free days 24 hours after CCP transfusion	76
Participants with oxygenation free days after 7 days after transfusion	103
Participants with oxygenation free days at discharge	167

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: During hospitalization, after receiving convalescent plasma. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hospitalized Patients With SARS CoV-2 Infection	0 of 189 (0%)	1 of 189 (0.5%)	22 of 189

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32113510Chen 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.
Background: PubMed 32219428Shen 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.
BackgroundHuaxia, (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: PubMed 32167489Casadevall 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.
Background: PubMed 32219429Roback 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.
Backgroundhttps://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
BackgroundGuidance 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
BackgroundAABB'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
Derived from this study: PubMed 36295001Grubovic 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.
Individual participant dataSharing planned: Yes. IPD will be shared on request to other clinical researchers involved in similar trials or meta-analysis

Related trials for Convalescent Plasma

RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
RecruitingObservational study
Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
Covid19
RecruitingPhase 2
Convalescent Plasma as a Possible Treatment for COVID-19
COVID-19

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rada Grubovic Rastvorceva, MD MSci PhD principal investigator

Institute for Transfusion Medicine of RNM

Sedulla Useini, MD principal investigator

Institute for Transfusion Medicine of RNM

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing anti-SARS-CoV-2 convalescent plasma in people with Convalescent Plasma and COVID-19, run by Institute for Transfusion Medicine of RNM at 1 site in North Macedonia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Oxygenation Support (time frame: 28 days after transfusion or until hospital discharge (whichever comes first)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04397523, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.