COVID 19Phase 1CPCPNCT04521036
Convalescent Plasma for COVID-19 Patients (CPCP)
A Phase 1 study testing Convalescent Plasma as Therapy for Covid-19 patients in people with COVID 19, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
Trial summary
Prior findings in various viral respiratory diseases including SARS-CoV-related pneumonia suggest that convalescent plasma can reduce mortality, although formal proof of efficacy is still lacking. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID 19
- What is being tested?
- Convalescent Plasma as Therapy for Covid-19 patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2020to 30 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- SARS-CoV-19 PCR positive
- Moderate stage and above
- Time from onset to screening ≤ 21 days, the SARS-CoV-2 test is still positive
Who cannot join
- Patients with a history of autoimmune disease or IgA deficiency
- Patients with a history of allergy
- Multi-organ/system failure
- Pregnant or breastfeeding at the time of study
- Cancer, history of heart failure, stroke, bronchial asthma
- Multi-organ/system failure with indications for dialysis, severe hypoxia, failure with conventional treatment methods, indications for ECMO.
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- The patient is infected with multidrug-resistant bacteria.
- The patient is participating in another study.
- Time from onset to screening> 21 days
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, 100000
About this study
Official title: Assessment of the Safety and Efficacy of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness
Prior findings in various viral respiratory diseases including SARS-CoV-related pneumonia suggest that convalescent plasma can reduce mortality, although formal proof of efficacy is still lacking. The investigators propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in COVID19 patients who are in the medium stage. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illnesses. The study team wants to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality. In addition, a major secondary objective to reduce the requirement for and/or duration of mechanical ventilation. This phase is to test the safety and efficacy of CP therapy.
Read the detailed description
Coronaviruses are among the most common causes of the common cold in humans. In recent decades, coronavirus has caused several epidemics worldwide with a vast number of deaths such as severe acute respiratory syndrome-SARS (2003) with 8098 people infected, and 774 people died over 29 countries. The disease caused by SARS CoV-2 (COVID19) is manifest by fever, fatigue, dry cough, pharyngitis, and headache. In addition to the common clinical presentation of respiratory distress, and increasing frequency of cardiovascular manifestations has become evident.
In this context, the investigators propose to evaluate the safety and efficacy of intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in patients requiring hospitalization for symptomatic "high risk" COVID19 disease. The study team wants to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality. In addition, a major secondary objective to reduce the requirement for and/or duration of mechanical ventilation. This is a randomized clinical trial comparing convalescent plasma with the standard of care therapy in patients hospitalized for COVID-19 in Vietnam. Patients were randomized 1:1 and received 500 ml of plasma with anti-SARSCoV-2 neutralizing antibody titers of at least 1:80.
Written informed consent will be obtained all eligible subjects prior to participation.
Convalescent plasma will be obtained from male donors, nulliparous females, or female donors negative for HLA antibodies at least 14 days following recovery from COVID-19 infection.
- Conditions
- COVID 19
- Being tested
- Convalescent Plasma as Therapy for Covid-19 patients
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent Plasma as Therapy for Covid-19 patientsBiological
Patients in the treatment group will receive 500 ml from COVID-19 recovered donors
| Study group | Role | What they receive |
|---|---|---|
| Convalescent plasma | Experimental | Standard of care plus 500 mL of convalescent plasma from COVID-19 recovered donors Receives: Biological: Convalescent Plasma as Therapy for Covid-19 patients |
| Standard of care | No intervention | Standard of care (Supportive care, oxygen, antibiotics, no convalescent plasma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mortality
Change in mortality of high risk COVID 19 disease compared with the control arm
Measured: until hospital discharge or a maximum of 60 days whichever comes first
Secondary outcomes (3)
Change in requirement for mechanical ventilation
Change in the duration of mechanical ventilation in high risk COVID 19 disease compared with the control arm
Measured: until hospital discharge or a maximum of 60 days whichever comes first
Change in the duration of mechanical ventilation
Change in the time a participant will remain on the ventilator
Measured: until hospital discharge or a maximum of 60 days whichever comes first
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events during study period
Measured: Incidence of Treatment-Emergent Adverse Events until hospital discharge or a maximum of 60 days whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Dec 2020
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a randomized comparative trial. Patients will be randomized between the infusion of 500mL of Convalescent Plasma versus the standard of care
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam, National Hospital for Tropical Diseases, Hanoi, Vietnam, National Institute of Hematology and Blood Transfusion, Vietnam
- Responsible party
- Sponsor
- Investigators
- Liem Thanh Nguyen, PhD, Principal investigator, Vinmec Research Institute of Stem Cell and Gene Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521036
- Sponsor's protocol ID
- ISC.20.11.2
- Acronym
- CPCP
- Status last verified
- Jun 2024
- First submitted
- 18 Aug 2020
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Efficacy of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness
- ClinicalTrials.gov ID
- NCT04521036
- Acronym / sponsor ID
- CPCP / ISC.20.11.2
- Conditions
- COVID 19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene TechnologyUniversity, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam, National Hospital for Tropical Diseases, Hanoi, Vietnam, National Institute of Hematology and Blood Transfusion, Vietnam
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prior findings in various viral respiratory diseases including SARS-CoV-related pneumonia suggest that convalescent plasma can reduce mortality, although formal proof of efficacy is still lacking. The investigators propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in COVID19 patients who are in the medium stage. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illnesses. The study team wants to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality. In addition, a major secondary objective to reduce the requirement for and/or duration of mechanical ventilation. This phase is to test the safety and efficacy of CP therapy.
Detailed description
Coronaviruses are among the most common causes of the common cold in humans. In recent decades, coronavirus has caused several epidemics worldwide with a vast number of deaths such as severe acute respiratory syndrome-SARS (2003) with 8098 people infected, and 774 people died over 29 countries. The disease caused by SARS CoV-2 (COVID19) is manifest by fever, fatigue, dry cough, pharyngitis, and headache. In addition to the common clinical presentation of respiratory distress, and increasing frequency of cardiovascular manifestations has become evident.
In this context, the investigators propose to evaluate the safety and efficacy of intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in patients requiring hospitalization for symptomatic "high risk" COVID19 disease. The study team wants to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality. In addition, a major secondary objective to reduce the requirement for and/or duration of mechanical ventilation. This is a randomized clinical trial comparing convalescent plasma with the standard of care therapy in patients hospitalized for COVID-19 in Vietnam. Patients were randomized 1:1 and received 500 ml of plasma with anti-SARSCoV-2 neutralizing antibody titers of at least 1:80.
Written informed consent will be obtained all eligible subjects prior to participation.
Convalescent plasma will be obtained from male donors, nulliparous females, or female donors negative for HLA antibodies at least 14 days following recovery from COVID-19 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This trial is a randomized comparative trial. Patients will be randomized between the infusion of 500mL of Convalescent Plasma versus the standard of care
| Arm | Type | Receives |
|---|---|---|
| Convalescent plasma | Experimental | Biological: Convalescent Plasma as Therapy for Covid-19 patientsStandard of care plus 500 mL of convalescent plasma from COVID-19 recovered donors |
| Standard of care | No intervention | –Standard of care (Supportive care, oxygen, antibiotics, no convalescent plasma) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years
- SARS-CoV-19 PCR positive
- Moderate stage and above
- Time from onset to screening ≤ 21 days, the SARS-CoV-2 test is still positive
Key exclusion criteria (9 listed)
- Patients with a history of autoimmune disease or IgA deficiency
- Patients with a history of allergy
- Multi-organ/system failure
- Pregnant or breastfeeding at the time of study
- Cancer, history of heart failure, stroke, bronchial asthma
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 |
|---|---|---|
| Convalescent Plasma as Therapy for Covid-19 patientsPatients in the treatment group will receive 500 ml from COVID-19 recovered donors | Biological | Convalescent plasma |
Primary outcome
Change in mortality
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Change in mortality of high risk COVID 19 disease compared with the control arm
3 secondary outcomes
Change in requirement for mechanical ventilation
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Change in the duration of mechanical ventilation
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Incidence of Treatment-Emergent Adverse Events
Time frame: Incidence of Treatment-Emergent Adverse Events until hospital discharge or a maximum of 60 days whichever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Liem Thanh Nguyen, PhD principal investigator
Vinmec Research Institute of Stem Cell and Gene Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Convalescent Plasma as Therapy for Covid-19 patients in people with COVID 19, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
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 4 inclusion and 9 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 5 Jun 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 Vietnam. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in mortality (time frame: until hospital discharge or a maximum of 60 days whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2024.