Use of Multiple Doses of Convalescent Plasma in Mechanically Intubated Patients With COVID-19

COVID-19 Clinical Trial

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)

Status Completed

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT05595538
• Study type: Interventional
• Source: Hospital Regional Dr. Rafael Estévez
• Status: Completed
• Phase: Early Phase 1
• Start date: June 6, 2020
• Completion date: October 14, 2020