A study was conducted to evaluate the difference in clinical outcomes in severe/life-threatening COVID-19 patients treated with standard treatment versus standard treatment and convalescent plasma therapy.
Convalescent plasma is blood, liquid portion, from people who have recovered from COVID-19. Convalescent plasma has antibodies that the body uses to fight infections. Doctors are experimenting to see if using convalescent plasma can be a viable therapeutic option.
The primary outcome of this study was whether the patient shows improvement in clinical outcomes within a 28-day period. Clinical improvement was defined as a patient’s discharge from the hospital alive or having an improvement of at least 2 points on a disease severity scale of 1-6. The 6-point disease severity scale was described as 1 being discharged to 6 being death.
The
secondary outcome was the observation of 28-day mortality, time to discharge
from hospital, and results turning negative from baseline to negative at and up
to 72 hours using the rate of viral polymerase chain reaction (PCR).
There
were 103 participants with laboratory-confirmed COVID-19 patients with one or
more life-threatening signs such as hypoxaemia, respiratory distress, organ failure,
shock, or patients requiring ventilatory support. They were recruited from 7 medical
centers in Wuhan, China, from February 14 - April 1, 2020.
Patients in the intervention group (n=52) received convalescent therapy in addition to standard treatment. Patients in the control group (n=51) received standard treatment alone.
Participant demographic profile
Patients enrolled | 103 |
|
Patients completing the study | 101 | 98.1% |
Patient Median age | 70 |
|
Number of male patients | 60 | 58.3% |
Number of female patients | 43 | 41.7% |
Study results
Control Group | Intervention Group | ||
Total patients | Patients showing improvement in 28 days | Total patients | Patients showing improvement in 28 days |
51 | 22 (43%) | 52 | 27 (51.9%) |
Measure of Primary Outcome in Patients with severe disease
Control group | Intervention group |
15/22 (68.2%) | 21/23 (91.3%) |
Measure of Primary Outcome in Patients with life-threatening signs
Control group | Intervention group |
7/29 (24.1%) | 6/29 (20.7%) |
The difference in 28-day mortality (16% versus 24%)
and time to discharge by the 28th day from the hospital (51% versus
36%) was not deemed clinically significant. The intervention group receiving
convalescent plasma had a negative conversion rate of viral PCR at 72 hours (87.2%
intervention group vs. 37.5% control group (OR, 11.39 [95% CI, 3.91-33.18];
P < .001). Two patients in the intervention group were given supportive care
after experiencing negative events associated with the transfusion of convalescent
plasma.
Conclusion
The
addition of convalescent plasma in COVID-19 patients in addition to the
standard treatment did not result in better clinical outcomes than just
standard treatment alone.
Source: JAMA
Image Credit: iStock
