Li (2020)
Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19
https://dx.doi.org/10.1001/jama.2020.10044
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7270883/
Treatment
Treatment for COVID-19 (Treated with convalescent plasma vs. Not received)
Virus clearance
Odds ratio: 11.390 (3.910-33.180) Univariate analysis

China

Randomized clinical trial

Primary data collection

103

Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020.

A total of 103 patients were enrolled in this randomized clinical trial. They were assigned to either the convalescent plasma group or the control group in a 1:1 ratio and were categorized as follows: 23 patients in the convalescent plasma group and 22 patients in the control group had severe COVID-19, and 29 patients in the convalescent plasma group and 29 patients in the control group had life-threatening COVID-19. The median age was 70 years (IQR, 62-78 years) among all patients, 71 years (IQR, 66-82 years) for patients with severe COVID-19, and 69 years (IQR, 61-76 years) for patients with life-threatening COVID-19. Of the patients included in the study, 60 (58.3%) were men, and the percentages of men with severe and life-threatening COVID-19 were 53.3% and 62.1%, respectively. A total of 89.2% of the patients had a normal body temperature at the time of participation, and the median body temperature was 36.5 °C (IQR, 36.2-36.7 °C). Primary Clinical Outcome: For all patients combined, there was no significant difference in the primary outcome of time to clinical improvement within 28 days: 51.9% (27/52) in the convalescent plasma group vs 43.1% (22/51) in the control group. Secondary Clinical Outcomes: There was no significant difference in the secondary outcome of 28-day mortality (15.7% in the convalescent plasma group vs 24.0% in the control group).

Total

75 Day


Virus clearance

56

Viral nucleic acid negative rate - conversion of nasopharyngeal swab viral PCR results from positive at baseline to negative at follow-up assessed at 24, 48, and 72 hours. Once nasopharyngeal swab viral PCR testing yielded negative results 2 times consecutively, no further testing was performed.


Treatment

Treatment for COVID-19

Viral nucleic acid negative rate at 72 h, No./total (%)

Not received

Treated with convalescent plasma


Odds ratio

11.390 (3.910-33.180)

No

Yes

No

The model that included only the treatment group as the unadjusted model. All patients-Primary clinical outcome: Time to clinical improvement. Secondary clinical outcomes: Hospital discharge. Patients with severe disease - Primary clinical outcome: Time to clinical improvement. Secondary clinical outcomes: Hospital discharge. Patients with life-threatening disease - Primary clinical outcome: Time to clinical improvement. Secondary clinical outcomes: Hospital discharge.


none

Average

Yes