COVID 19Early Phase 1CPCPNCT04516954
Convalescent Plasma for COVID-19 Patients
A Early Phase 1 study testing Convalescent COVID 19 Plasma in people with COVID 19, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
Trial summary
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. 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 COVID 19 Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2020to 30 Apr 2021
- Phase
- Early 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
- Medium stage
- 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, 10000
About this study
Official title: Assessment of the Safety of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness
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. The first phase is to test the safety of CP therapy.
Read the detailed description
Coronaviruses are among the most common causes of the common cold in humans.1,2 In recent decades, coronavirus has caused several epidemic 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 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 single-arm, non-randomized, open-label treatment of eligible subjects defined as those who satisfy all inclusion criteria.
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 COVID 19 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.
Convalescent COVID 19 PlasmaBiological
A total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject
| Study group | Role | What they receive |
|---|---|---|
| Convalescent COVID 19 Plasma | Experimental | A total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject Receives: Biological: Convalescent COVID 19 Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety
Number of Adverse Events (AEs), and Serious Adverse Events (SAEs) of COVID 19 Patients:
Incidence of Treatment-Emergent Adverse Events (Data on the number of participants with treatment related adverse events will be assessed to determine the safety and tolerability of convalescent plasma)
Measured: At Day 28
Secondary outcomes (1)
Change in requirement for mechanical ventilatory support
Change in the duration of mechanical ventilation in COVID 19 patients compared with historic precedent cohorts
Measured: At Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Aug 2020
- Primary completion30 Mar 2021
- Study completion30 Apr 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516954
- Sponsor's protocol ID
- ISC.20.11.1
- Acronym
- CPCP
- Status last verified
- Jun 2024
- First submitted
- 17 Aug 2020
- Last updated
- 6 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness
- ClinicalTrials.gov ID
- NCT04516954
- Acronym / sponsor ID
- CPCP / ISC.20.11.1
- Conditions
- COVID 19
- Phase
- Early 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 Aug 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 18 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.
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. The first phase is to test the safety of CP therapy.
Detailed description
Coronaviruses are among the most common causes of the common cold in humans.1,2 In recent decades, coronavirus has caused several epidemic 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 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 single-arm, non-randomized, open-label treatment of eligible subjects defined as those who satisfy all inclusion criteria.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Convalescent COVID 19 Plasma | Experimental | Biological: Convalescent COVID 19 PlasmaA total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject |
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
- Medium stage
- 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 COVID 19 PlasmaA total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject | Biological | Convalescent COVID 19 Plasma |
Primary outcome
Evaluate the safety
Time frame: At Day 28
Number of Adverse Events (AEs), and Serious Adverse Events (SAEs) of COVID 19 Patients: Incidence of Treatment-Emergent Adverse Events (Data on the number of participants with treatment related adverse events will be assessed to determine the safety and tolerability of convalescent plasma)
1 secondary outcome
Change in requirement for mechanical ventilatory support
Time frame: At Day 28
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 6 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Convalescent COVID 19 Plasma 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 6 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Evaluate the safety (time frame: At Day 28). 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 6 Jun 2024.