Related Experiment Video
Updated: Dec 9, 2025
Isolation of Exosome-Enriched Extracellular Vesicles Carrying Granulocyte-Macrophage Colony-Stimulating Factor from Embryonic Stem Cells
Published on: November 11, 2021
Effect of Recombinant Human Granulocyte Colony-Stimulating Factor for Patients With Coronavirus Disease 2019
Lin-Ling Cheng1,2, Wei-Jie Guan1, Chong-Yang Duan3
1State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.
Insights
Recombinant human granulocyte colony-stimulating factor (rhG-CSF) did not speed up recovery for COVID-19 patients with low lymphocytes. However, rhG-CSF may reduce critical illness and death in these patients.
Area of Science:
- Infectious Diseases
- Hematology
- Critical Care Medicine
Background:
- Lymphopenia is a common finding in COVID-19 patients and is associated with adverse clinical outcomes.
- Identifying therapeutic strategies to improve lymphocyte counts and clinical outcomes in COVID-19 is crucial.
Purpose of the Study:
- To evaluate the efficacy of recombinant human granulocyte colony-stimulating factor (rhG-CSF) in improving clinical outcomes for patients with COVID-19 and lymphopenia.
- To determine if rhG-CSF therapy can increase peripheral blood leukocyte and lymphocyte counts, leading to clinical improvement.
Main Methods:
- An open-label, multicenter, randomized clinical trial was conducted involving 200 patients with COVID-19, pneumonia, and lymphopenia without comorbidities.
- Patients were randomized to receive either usual care alone or usual care plus three doses of rhG-CSF.
- The primary endpoint was the time to clinical improvement based on a 7-category disease severity score.
Main Results:
- Time to clinical improvement was similar between the rhG-CSF group and the usual care group (12 vs. 13 days, P=.06).
- The proportion of patients progressing to acute respiratory distress syndrome, sepsis, or septic shock was significantly lower in the rhG-CSF group (2% vs. 15%).
- Mortality at 21 days was reduced in the rhG-CSF group (2% vs. 10%), and lymphocyte counts were higher on day 5.
Conclusions:
- rhG-CSF treatment did not accelerate clinical improvement in patients with COVID-19 and lymphopenia.
- rhG-CSF therapy may potentially reduce the progression to critical illness and mortality in this patient population.
- Larger studies are warranted to confirm these findings and explore rhG-CSF in a broader range of COVID-19 patients.
Importance:
Lymphopenia is common and correlates with poor clinical outcomes in patients with coronavirus disease 2019 (COVID-19).
Objective:
To determine whether a therapy that increases peripheral blood leukocyte and lymphocyte cell counts leads to clinical improvement in patients with COVID-19.
Design, Setting And Participants:
Between February 18 and April 10, 2020, we conducted an open-label, multicenter, randomized clinical trial at 3 participating centers in China. The main eligibility criteria were pneumonia, a blood lymphocyte cell count of 800 per μL (to convert to ×109/L, multiply by 0.001) or lower, and no comorbidities. Severe acute respiratory syndrome coronavirus 2 infection was confirmed with reverse-transcription polymerase chain reaction testing.
Exposures:
Usual care alone, or usual care plus 3 doses of recombinant human granulocyte colony-stimulating factor (rhG-CSF, 5 μg/kg, subcutaneously at days 0-2).
Main Outcomes And Measures:
The primary end point was the time from randomization to improvement of at least 1 point on a 7-category disease severity score.
Results:
Of 200 participants, 112 (56%) were men and the median (interquartile range [IQR]) age was 45 (40-55) years. There was random assignment of 100 patients (50%) to the rhG-CSF group and 100 (50%) to the usual care group. Time to clinical improvement was similar between groups (rhG-CSF group median of 12 days (IQR, 10-16 days) vs usual care group median of 13 days (IQR, 11-17 days); hazard ratio, 1.28; 95% CI, 0.95-1.71; P = .06). For secondary end points, the proportion of patients progressing to acute respiratory distress syndrome, sepsis, or septic shock was lower in the rhG-CSF group (rhG-CSF group, 2% vs usual care group, 15%; difference, -13%; 95%CI, -21.4% to -5.4%). At 21 days, 2 patients (2%) had died in the rhG-CSF group compared with 10 patients (10%) in the usual care group (hazard ratio, 0.19; 95%CI, 0.04-0.88). At day 5, the lymphocyte cell count was higher in the rhG-CSF group (rhG-CSF group median of 1050/μL vs usual care group median of 620/μL; Hodges-Lehmann estimate of the difference in medians, 440; 95% CI, 380-490). Serious adverse events, such as sepsis or septic shock, respiratory failure, and acute respiratory distress syndrome, occurred in 29 patients (14.5%) in the rhG-CSF group and 42 patients (21%) in the usual care group.
Conclusion And Relevance:
In preliminary findings from a randomized clinical trial, rhG-CSF treatment for patients with COVID-19 with lymphopenia but no comorbidities did not accelerate clinical improvement, but the number of patients developing critical illness or dying may have been reduced. Larger studies that include a broader range of patients with COVID-19 should be conducted.
Trial Registration:
Chinese Clinical Trial Registry: ChiCTR2000030007.
More Related Videos
Related Concept Videos
01:01Regulation of Hematopoietic Stem Cells
01:15Differentiation of Common Myeloid Progenitor Cells