COVID-19Phase 1NCT04333355
Safety in Convalescent Plasma Transfusion to COVID-19
A Phase 1 study testing Convalescent Plasma in people with COVID-19, run by TecSalud Investigación Clínica at 1 site in Mexico.
Trial summary
There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Convalescent Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- 8 May 2020to 20 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years and older
- Confirmed SARS-CoV-2 Infection by RT-PCR.
- Serious or life-threatening infection defined as:
- Serious:
- Dyspnea
- Respiratory rate greater than or equal to 30 cycles / minute.
Show all 15Show fewer
- Blood oxygen saturation less than or equal to 93% with an oxygen supply greater than 60%.
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
- A 50% increase in pulmonary infiltrates defined by computer tomography scans in 24 to 48 hours.
- Life-threatening infection:
- respiratory failure.
- septic shock.
- dysfunction or multiple organ failure.
- Refractory to treatment with azithromycin / hydroxychloroquine or chloroquine / ritonavir / lopinavir defined as: 48 hours with no improvement in the modified parameters such as serious or clinically imminent infection.
- Signed Informed consent by the patient or by the person responsible for the patient in the case of critically ill patients (spouse or parents).
Who cannot join
- Patients with a history of allergic reaction to any type of previous transfusion.
- Heart failure patients at risk of volume overload.
- Patients with a history of chronic kidney failure in the dialysis phase.
- Patients with previous hematological diseases (anemia less than 10 grams of hemoglobin, platelets greater than 100,000 / µl).
- Any case where the investigator decides that the patient is not suitable for the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection
There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. This plasma will be infused in patients affected by the same virus, but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. The investigator will evaluate the safety of this procedure by accounting for any adverse event.
Read the detailed description
There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma.
The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. Donors will be screened for infectious diseases including sARS-CoV-2 and will be programmed for apheresis the next day. The investigaotr will process one plasmatic volume per donor and this will be guarded in the blood bank until required by the principal investigator.
Patients or receptors will be screened and selected by the research team according to eligibility criteria, including severe disease refractory to treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. Plasma will be fractioned in 250ml. Infusion will start after a clinical evaluation and blood sampling. Patients will remain under careful observation. If no adverse event is present, infusion will be repeated after 24 hours and the investigator will evaluate patients again 48 hours after the second transfusion. A final evaluation will be performed at day 14. The investigator will evaluate the safety of this procedure by accounting for any adverse event.
- Conditions
- COVID-19
- Being tested
- Convalescent Plasma
- Keywords
- COVID-19, SARS-CoV-2, 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.
Convalescent PlasmaBiological
Also called Supportive standard care
Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients receiving Convalescent Plasma | Experimental | Convalescent Plasma from patients who recently recover from COVID-19 Receives: Biological: Convalescent Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects
Identify possible adverse effects after the administration of convalescent plasma
Measured: 14 days
Secondary outcomes (5)
Heart Failure
Development of heart failure during convalescent plasma transfusion or after it.
Measured: 14 days
Pulmonary Edema
Development of pulmonary edema during convalescent plasma transfusion or after it.
Measured: 14 days
Allergic Reaction
Development of any allergic reaction during convalescent plasma transfusion or after it.
Measured: 14 days
Viral load of SARS-CoV-2
RT PCR SARS-CoV-2
Measured: 48 hrs
Viral load of SARS-CoV-2
RT PCR SARS-CoV-2
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start8 May 2020
- Primary completion20 Aug 2020
- Study completion20 Aug 2020
Why it stopped: Other clinical trails probed that the use of convalescent plasma for patients with COVID-19 is safe .
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- TecSalud Investigación Clínica
- Sponsor type
- University, hospital or other
- Collaborators
- Tecnologico de Monterrey
- Responsible party
- Principal investigator, Servando Cardona-Huerta, TecSalud Investigación Clínica
- Investigators
- José Fe Castilleja-Leal, MD., Principal investigator, Hospital San José
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333355
- Sponsor's protocol ID
- PC-TecSalud Fase I
- Status last verified
- Feb 2021
- First submitted
- 31 Mar 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04333355
- Acronym / sponsor ID
- PC-TecSalud Fase I
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, Convalescent plasma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Other clinical trails probed that the use of convalescent plasma for patients with COVID-19 is safe .
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TecSalud Investigación ClínicaUniversity, hospital or other
- Collaborators
- Tecnologico de Monterrey
- Study start
- 8 May 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 3 Apr 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.
There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. This plasma will be infused in patients affected by the same virus, but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. The investigator will evaluate the safety of this procedure by accounting for any adverse event.
Detailed description
There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma.
The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. Donors will be screened for infectious diseases including sARS-CoV-2 and will be programmed for apheresis the next day. The investigaotr will process one plasmatic volume per donor and this will be guarded in the blood bank until required by the principal investigator.
Patients or receptors will be screened and selected by the research team according to eligibility criteria, including severe disease refractory to treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. Plasma will be fractioned in 250ml. Infusion will start after a clinical evaluation and blood sampling. Patients will remain under careful observation. If no adverse event is present, infusion will be repeated after 24 hours and the investigator will evaluate patients again 48 hours after the second transfusion. A final evaluation will be performed at day 14. The investigator will evaluate the safety of this procedure by accounting for any adverse event.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients receiving Convalescent Plasma | Experimental | Biological: Convalescent PlasmaConvalescent Plasma from patients who recently recover from COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients 18 years and older
- Confirmed SARS-CoV-2 Infection by RT-PCR.
- Serious or life-threatening infection defined as:
- Refractory to treatment with azithromycin / hydroxychloroquine or chloroquine / ritonavir / lopinavir defined as: 48 hours with no improvement in the modified parameters such as serious or clinically imminent infection.
- Signed Informed consent by the patient or by the person responsible for the patient in the case of critically ill patients (spouse or parents).
Key exclusion criteria (5 listed)
- Patients with a history of allergic reaction to any type of previous transfusion.
- Heart failure patients at risk of volume overload.
- Patients with a history of chronic kidney failure in the dialysis phase.
- Patients with previous hematological diseases (anemia less than 10 grams of hemoglobin, platelets greater than 100,000 / µl).
- Any case where the investigator decides that the patient is not suitable for the protocol.
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 PlasmaAlso: Supportive standard careAlong with the administration of convalescent plasma, patients will continue to receive supportive standard care. | Biological | COVID-19 patients receiving Convalescent Plasma |
Primary outcome
Side effects
Time frame: 14 days
Identify possible adverse effects after the administration of convalescent plasma
5 secondary outcomes
Heart Failure
Time frame: 14 days
Pulmonary Edema
Time frame: 14 days
Allergic Reaction
Time frame: 14 days
Viral load of SARS-CoV-2
Time frame: 48 hrs
Viral load of SARS-CoV-2
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Other clinical trails probed that the use of convalescent plasma for patients with COVID-19 is safe .). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
José Fe Castilleja-Leal, MD. principal investigator
Hospital San José
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 in people with COVID-19, run by TecSalud Investigación Clínica at 1 site in Mexico.
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 15 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Feb 2021. 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 Mexico. 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 was stopped early (reason given: Other clinical trails probed that the use of convalescent plasma for patients with COVID-19 is safe .). Results are not available in the source record.
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?
Side effects (time frame: 14 days). 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 NCT04333355, which also lists 1 linked publication.
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 10 Feb 2021.