COVID-19Early Phase 1NCT05595538
Use of Multiple Doses of Convalescent Plasma in Mechanically Intubated Patients With COVID-19
A Early Phase 1 study testing Multiple doses of anti-SARS-CoV-2 Convalescent Plasma in people with COVID-19, run by Hospital Regional Dr. Rafael Estévez at 1 site in Panama.
Trial summary
This study will assess the feasibility and safety of administering multiple doses of convalescent plasma to Covid-19 positive patients admitted to the Intensive Care Unit (ICU) receiving mechanical ventilation. Donor plasma will be obtained from Covid-19 recovered patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Multiple doses of anti-SARS-CoV-2 Convalescent Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePanama
- Study dates
- 6 Jun 2020to 14 Oct 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 Real Time-polymerase chain reaction(PCR) testing.
- Subject or proxy (including by phone) is willing and able to provide written or digital informed consent and comply with all protocol requirements.
- Intubated
- Consent to storage of specimens for future testing.
Who cannot join
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
- Severe multi-organ failure, and hemodynamic instability.
- Other documented uncontrolled infections.
- Severe disseminated intravascular coagulopathy (DIC) needing factor replacement, FreshFrozen Plasma, cryoprecipitate.
- On dialysis.
- Active intracranial bleeding.
- Clinically significant myocardial ischemia.
Trial locations and contacts
1 site in 1 country.
Panama1 site
1. Complejo Hospitalario Metropolitano Arnulfo Arias Madrid, Caja de Seguro Social
Panama City
About this study
Official title: A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Mechanically Ventilated Intubated Patients With Respiratory Failure Due to Coronavirus Disease (COVID-19)
This study will assess the feasibility and safety of administering multiple doses of convalescent plasma to Covid-19 positive patients admitted to the Intensive Care Unit (ICU) receiving mechanical ventilation. Donor plasma will be obtained from Covid-19 recovered patients. All plasma used in this protocol will be collected following the guidelines issued by the Food and Drug Administration (FDA) and the Ministry of Health in Panama.
Every patient recruited will receive one or two plasma units infused on days 0, 2, 4, 6, and 8. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma more than once. The investigators will evaluate the safety and feasibility of this study by accounting for any related adverse event.
The secondary study endpoints are overall survival at days 14, 28, and 60 after the first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow-up until day nine and on days 14, 28, and 60.
Read the detailed description
From historical and anecdotal data on convalescent plasma, it seems its administration is safe in cases of coronavirus infection. Now, the high mortality of COVID-19, particularly in elderly and vulnerable persons such as critically ill patients, suggests that the benefits of its use in those at high risk for death outweigh the risks. However, for all cases where convalescent plasma administration is considered, a risk-benefit assessment must be conducted to assess individual variables.
This study proposed the follow-up of 30 intubated patients due to COVID-19 who have been admitted to the ICU and have consented to receive five doses of one or two units of convalescent plasma.
Every patient will have a follow-up from the consent day to day 60. The study team will monitor and record: vital signs, daily ventilatory requirements, and assessment of clinical status, including new medical conditions and adverse events.
- Conditions
- COVID-19
- Being tested
- Multiple doses of anti-SARS-CoV-2 Convalescent Plasma
- Keywords
- Convalescent plasma, critically ill, SARS-CoV-2, COVID-19, neutralizing antibodies
- Medical subject headings
- COVID-19, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple doses of anti-SARS-CoV-2 Convalescent PlasmaBiological
Also called COVID-19 Convalescent Plasma
SARS-CoV-2 Convalescent Plasma(1-2 units; ~300-600 mL with the presence of IgG anti-SARS-CoV-2.
| Study group | Role | What they receive |
|---|---|---|
| Intubated COVID-19 patients admitted to the ICU. | Experimental | Participants intubated who consent immediately before intubation to receive more than one dose of COVID-19 convalescent plasma. Receives: Biological: Multiple doses of anti-SARS-CoV-2 Convalescent Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who received at least one unit more than one day
Transfusion of multiple doses (up to 5 doses) of 300-600 ml of convalescent plasma from COVID-19
Measured: 8 days
Secondary outcomes (4)
Development of plasma transfusion reaction
presence of any sign or symptoms of plasma transfusion reaction (TACO, TRALI, fever, rash)
Measured: 8 days
Overall Survival
overall survival up to day 60
Measured: 60 days
oxygen Support
type of ventilatory support by days 9, 14, 28, and 60. The options for types of oxygen support are: Mechanical Ventilation, Non/invasive ventilation, and no support needed.
Measured: 60 days
Clinical Status
Change in 7-point ordinal clinical deterioration scale pre-transfusion to Days 1, 3, 7, 9, 14, 28 and 60 post-transfusion. The 7-point ordinal scale measured by: 7-death, 6-ICU patient who requires extracorporeal membrane oxygenation (ECMO) or mechanical ventilation; 5-ICU patient, do not requires ECMO or mechanical ventilation; 4 -hospitalization and requires supplemental oxygen; 3- hospitalization without supplemental oxygen; 2- limitation of activities, discharge from hospital 1- no limitation of activities, discharge from hospital.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start6 Jun 2020
- Primary completion29 Sep 2020
- Study completion14 Oct 2020
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Regional Dr. Rafael Estévez
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Dr. Arnulfo Arias Madrid, Hospital Santo Tomas, Hospital Punta Pacífica, Pacífica Salud, Insituto Conmemorativo Gorgas de Estudios para la Salud, Sociedad Panameña de Hematología, Institute of Scientific Research and High Technology Services (INDICASAT AIP), University of Panama, Sistema Nacional de Investigación de Panamá
- Responsible party
- Sponsor
- Investigators
- Ricardo Aguilar, M.D, Principal investigator, 1. Complejo Hospitalario Metropolitano Arnulfo Arias Madrid, Caja de Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595538
- Sponsor's protocol ID
- SPH-COVID-19
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Mechanically Ventilated Intubated Patients With Respiratory Failure Due to Coronavirus Disease (COVID-19)
- ClinicalTrials.gov ID
- NCT05595538
- Acronym / sponsor ID
- SPH-COVID-19
- Conditions
- COVID-19
- Keywords
- Convalescent plasma, critically ill, SARS-CoV-2, COVID-19, neutralizing antibodies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Regional Dr. Rafael EstévezUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Dr. Arnulfo Arias Madrid, Hospital Santo Tomas, Hospital Punta Pacífica, Pacífica Salud, Insituto Conmemorativo Gorgas de Estudios para la Salud, Sociedad Panameña de Hematología, Institute of Scientific Research and High Technology Services (INDICASAT AIP), University of Panama, Sistema Nacional de Investigación de Panamá
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 27 Oct 2022 (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.
This study will assess the feasibility and safety of administering multiple doses of convalescent plasma to Covid-19 positive patients admitted to the Intensive Care Unit (ICU) receiving mechanical ventilation. Donor plasma will be obtained from Covid-19 recovered patients. All plasma used in this protocol will be collected following the guidelines issued by the Food and Drug Administration (FDA) and the Ministry of Health in Panama.
Every patient recruited will receive one or two plasma units infused on days 0, 2, 4, 6, and 8. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma more than once. The investigators will evaluate the safety and feasibility of this study by accounting for any related adverse event.
The secondary study endpoints are overall survival at days 14, 28, and 60 after the first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow-up until day nine and on days 14, 28, and 60.
Detailed description
From historical and anecdotal data on convalescent plasma, it seems its administration is safe in cases of coronavirus infection. Now, the high mortality of COVID-19, particularly in elderly and vulnerable persons such as critically ill patients, suggests that the benefits of its use in those at high risk for death outweigh the risks. However, for all cases where convalescent plasma administration is considered, a risk-benefit assessment must be conducted to assess individual variables.
This study proposed the follow-up of 30 intubated patients due to COVID-19 who have been admitted to the ICU and have consented to receive five doses of one or two units of convalescent plasma.
Every patient will have a follow-up from the consent day to day 60. The study team will monitor and record: vital signs, daily ventilatory requirements, and assessment of clinical status, including new medical conditions and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubated COVID-19 patients admitted to the ICU. | Experimental | Biological: Multiple doses of anti-SARS-CoV-2 Convalescent PlasmaParticipants intubated who consent immediately before intubation to receive more than one dose of COVID-19 convalescent plasma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 Real Time-polymerase chain reaction(PCR) testing.
- Subject or proxy (including by phone) is willing and able to provide written or digital informed consent and comply with all protocol requirements.
- Intubated
- Consent to storage of specimens for future testing.
Key exclusion criteria (7 listed)
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
- Severe multi-organ failure, and hemodynamic instability.
- Other documented uncontrolled infections.
- Severe disseminated intravascular coagulopathy (DIC) needing factor replacement, FreshFrozen Plasma, cryoprecipitate.
- On dialysis.
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 |
|---|---|---|
| Multiple doses of anti-SARS-CoV-2 Convalescent PlasmaAlso: COVID-19 Convalescent PlasmaSARS-CoV-2 Convalescent Plasma(1-2 units; ~300-600 mL with the presence of IgG anti-SARS-CoV-2. | Biological | Intubated COVID-19 patients admitted to the ICU. |
Primary outcome
Percentage of participants who received at least one unit more than one day
Time frame: 8 days
Transfusion of multiple doses (up to 5 doses) of 300-600 ml of convalescent plasma from COVID-19
4 secondary outcomes
Development of plasma transfusion reaction
Time frame: 8 days
Overall Survival
Time frame: 60 days
oxygen Support
Time frame: 60 days
Clinical Status
Time frame: 60 days
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 27 Oct 2022.
- 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.
Ricardo Aguilar, M.D principal investigator
1. Complejo Hospitalario Metropolitano Arnulfo Arias Madrid, Caja de Seguro Social
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 Multiple doses of anti-SARS-CoV-2 Convalescent Plasma in people with COVID-19, run by Hospital Regional Dr. Rafael Estévez at 1 site in Panama.
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 5 inclusion and 7 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 27 Oct 2022. 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 Panama. 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?
Percentage of participants who received at least one unit more than one day (time frame: 8 days). 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 27 Oct 2022.