- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05595538
Use of Multiple Doses of Convalescent Plasma in Mechanically Intubated Patients With COVID-19
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
-
Panama, Panama
- 1. Complejo Hospitalario Metropolitano Arnulfo Arias Madrid, Caja de Seguro Social
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intubated COVID-19 patients admitted to the ICU.
Participants intubated who consent immediately before intubation to receive more than one dose of COVID-19 convalescent plasma.
|
SARS-CoV-2 Convalescent Plasma(1-2 units; ~300-600 mL with the presence of IgG anti-SARS-CoV-2.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of plasma transfusion reaction
Time Frame: 8 days
|
presence of any sign or symptoms of plasma transfusion reaction (TACO, TRALI, fever, rash)
|
8 days
|
Overall Survival
Time Frame: 60 days
|
overall survival up to day 60
|
60 days
|
oxygen Support
Time Frame: 60 days
|
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.
|
60 days
|
Clinical Status
Time Frame: 60 days
|
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.
|
60 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ricardo Aguilar, M.D, 1. Complejo Hospitalario Metropolitano Arnulfo Arias Madrid, Caja de Seguro Social
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPH-COVID-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on Multiple doses of anti-SARS-CoV-2 Convalescent Plasma
-
Noah MerinJohns Hopkins UniversityTerminatedCovid-19 | Sars-CoV2United States
-
Thomas BenfieldTerminatedCOVID | Corona Virus Infection | Viral PneumoniaDenmark
-
Orthosera Kft.University of Pecs; Semmelweis University; Hungarian National Blood Service; Humán...Recruiting
-
University of the PhilippinesTerminated
-
Medical College of WisconsinFroedtert HospitalCompletedCOVID-19United States
-
U.S. Army Medical Research and Development CommandNo longer availableTreatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)Severe Acute Respiratory Syndrome Coronavirus 2United States, Germany, Afghanistan, Djibouti, Guam, Iraq, Japan, Kuwait
-
Institute for Transfusion Medicine of RNMUniversity Clinic for Infectious Diseases, North MacedoniaCompletedCOVID-19 | SARS-CoV 2 | Convalescent PlasmaNorth Macedonia
-
Ascension South East MichiganWithdrawn
-
Joakim DillnerKarolinska University Hospital; Karolinska Institutet; Danderyd HospitalCompleted