Clinical trial NCT05595538: Use of Multiple Doses of Convalescent Plasma in Mechanically Intubated Patients With COVID-19
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: COVID-19
Keywords: Convalescent plasma
critically ill
SARS-CoV-2
COVID-19
neutralizing antibodies
Lead sponsor: Hospital Regional Dr. Rafael Estévez
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario Dr. Arnulfo Arias Madrid
name: Hospital Santo Tomas
name: Hospital Punta Pacífica, Pacífica Salud
name: Insituto Conmemorativo Gorgas de Estudios para la Salud
name: Sociedad Panameña de Hematología
name: Institute of Scientific Research and High Technology Services (INDICASAT AIP)
name: University of Panama
name: Sistema Nacional de Investigación de Panamá
First posted: 2022-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 Real Time-polymerase chain reaction(PCR) testing.
3. Subject or proxy (including by phone) is willing and able to provide written or digital informed consent and comply with all protocol requirements.
4. Intubated
5. Consent to storage of specimens for future testing.

Exclusion Criteria:

1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
2. Severe multi-organ failure, and hemodynamic instability.
3. Other documented uncontrolled infections.
4. Severe disseminated intravascular coagulopathy (DIC) needing factor replacement, FreshFrozen Plasma, cryoprecipitate.
5. On dialysis.
6. Active intracranial bleeding.
7. Clinically significant myocardial ischemia.

Primary outcomes:
measure: Percentage of participants who received at least one unit more than one day
timeFrame: 8 days
Secondary outcomes:
measure: Development of plasma transfusion reaction
timeFrame: 8 days
measure: Overall Survival
timeFrame: 60 days
measure: oxygen Support
timeFrame: 60 days
measure: Clinical Status
timeFrame: 60 days
Other outcomes:
Locations:
city: Panama
country: Panama
facility: 1. Complejo Hospitalario Metropolitano Arnulfo Arias Madrid, Caja de Seguro Social
Study officials:
affiliation: 1. Complejo Hospitalario Metropolitano Arnulfo Arias Madrid, Caja de Seguro Social
name: Ricardo Aguilar, M.D
role: PRINCIPAL_INVESTIGATOR
References: