Study design and participants
This retrospective cohort study was conducted on confirmed
SARS-CoV-2
infected patients who were admitted to Beijing Ditan Hospital from
Jan.13 2020 to Apr. 23.
The
institutional review boards approved this study and patient-level
informed consent was waived owing to its retrospective nature.
SARS-CoV-2 infection was diagnosed by
RT-PCR
assay of respiratory tract samples tested by the local Center for
Disease Control or by our institutional laboratory. Pneumonia was
defined as new, lower respiratory tract symptoms such as fever or
chills, cough or shortness of breath, and new focal chest signs,
coinciding with new onset or progressive pulmonary infiltrates on chest
radiography. The severity of COVID-19 was defined in accordance with the
China’s COVID-19 management guidelines (version 7.0).
All
confirmed patients were offered treatment with standard care including
as necessary,
supplemental
oxygen, antibiotic agents, or traditional Chinese medicine. The
potential
antiviral
therapy for
SARS-CoV-2
assigned two groups: receiving
Kaletra
(500 mg twice daily, orally) plus
interferon
alfa-2b (interferon, 5 million units twice daily, nebulization) or
interferon alfa-2b alone. Initially, a total of 196 cases were
identified (Figure 1.). Among these, cases (n=29) were excluded for
patients who were younger than 18 years and critically ill patients.
Among the 167 remaining participants, cases were excluded (n=44)on the
basis of other antiviral therapy including oseltamivir, chloroquine
phosphate, and ribavirin. Eventually, 123 participants were enrolled in
the study. The main exposure divided into two groups:
Kaletra plus interferon alfa-2b
therapy (n=67), defined as the use
of Kaletra and interferon alfa-2b combination, and interferon alfa-2b
alone (n=44). The comparator group was treatment with standard care
without use of Kaletra and interferon alfa-2b(n=12).The final groups for
the 123 included cases were: standard care group
(n=12),
interferon alfa-2b group (n=44), Kaletra plus interferon alfa-2b group
(n=67).