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Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial / 中国结合医学杂志
Chinese journal of integrative medicine ; (12): 648-655, 2020.
Article in English | WPRIM | ID: wpr-827079
ABSTRACT
OBJECTIVES@#To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.@*METHODS@#A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 11 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.@*RESULTS@#An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).@*CONCLUSIONS@#Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).
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Full text: Available Index: WPRIM (Western Pacific) Main subject: Pneumonia, Viral / Severity of Illness Index / Administration, Inhalation / Drug Administration Schedule / Drugs, Chinese Herbal / China / Survival Rate / Follow-Up Studies / Mortality / Interferon-alpha Type of study: Controlled clinical trial / Diagnostic study / Etiology study / Observational study / Prognostic study / Risk factors Limits: Adult / Female / Humans / Male Country/Region as subject: Asia Language: English Journal: Chinese journal of integrative medicine Year: 2020 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: Pneumonia, Viral / Severity of Illness Index / Administration, Inhalation / Drug Administration Schedule / Drugs, Chinese Herbal / China / Survival Rate / Follow-Up Studies / Mortality / Interferon-alpha Type of study: Controlled clinical trial / Diagnostic study / Etiology study / Observational study / Prognostic study / Risk factors Limits: Adult / Female / Humans / Male Country/Region as subject: Asia Language: English Journal: Chinese journal of integrative medicine Year: 2020 Type: Article