COVID-19
Conditions
Keywords
COVID-19, Convalescent plasma
Brief summary
Open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with COVID-19 infection. This study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. Adults older than 18 years old, hospitalized with diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or life-threatening disease, will be included to the study after obtaining inform consent by the patient of a direct family member. Participants will be then randomized 1:1 to the experimental and the control groups. Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of care. Participants at the control group will receive standard of care. Safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy.
Detailed description
The study protocol can be found in: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6
Interventions
BIOLOGICALConvalescent plasma
Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.
Sponsors
Universidad Peruana Cayetano Heredia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation. * Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria: * Respiratory frequency \>22 * O2 saturation ≤93% * PaO2 50mmHg * PaO2/FiO2 \<300 * Or critical disease with one or more of the following criteria: * Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours * Shock * Inform consent signed by patient or direct family member.
Exclusion criteria
* Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components * Multiorgan failure, defined by a SOFA score of \>5 * hemodynamically unstable, with mean arterial pressure \<60 mmHg, refractory to vasopressors use * Uncontrolled concomitant infection * Disseminated intravascular coagulation * Myocardial infarction * Acute coronary disease * Patient on dialysis * Intracranial bleeding active within the last 7 days * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion-related Serious Adverse Events | 14 days after randomization | Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 30 days after randomization or until hospital discharge, whatever comes first | Number of days from date of enrollment to date of discharge |
| Length of ICU stay | 30 days after randomization or until hospital discharge, whatever comes first | Number of days from date of admission to the ICU to date of discharge from ICU |
| All-cause in-hospital mortality | 30 days after randomization | Death during hospitalization within the first 30 days after enrollment |
| Duration of mechanical ventilation | 30 days after randomization or until hospital discharge, whatever comes first | Number of days from date of intubation to date of successful extubation |
| Clinical Improvement at 14 days | At 3, 14 and 30 days after randomization | Improvement of 2 or more points in the WHO progression scale |
| Need of invasive mechanical ventilation | 30 days after randomization or until hospital discharge, whatever comes first | Requirement of invasive mechanical ventilation (Yes/No). Evaluated only for those participants that were on non-invasive ventilatory support at time of randomization |
Countries
Peru
Outcome results
None listed