The use of standardized Brazilian green propolis extract (EPP-AF) as an adjunct treatment for hospitalized COVID-19 patients (BeeCovid2): a structured summary of a study protocol for a randomized controlled trial.
The use of standardized Brazilian green propolis extract (EPP-AF) as an adjunct treatment for hospitalized COVID-19 patients (BeeCovid2): a structured summary of a study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-022-06176-1
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发表时间：
2022-04-04
期刊：
影响因子：
2.5
通讯作者：
da Hora Passos R
中科院分区：
文献类型：
--
作者：
Silveira MAD;de Souza SP;Dos Santos Galvão EB;Teixeira MB;Gomes MMD;Damiani LP;Bahiense BA;Cabral JB;De Oliveira CWLM;Mascarenhas TR;Pinheiro PCG;Alves MS;de Melo RMV;Berretta AA;Leite FM;Nonaka CKV;de Freitas Souza BS;Mendes AVA;da Guarda SF;da Hora Passos R
2019冠状病毒病（COVID-19）疫情持续蔓延，影响大量人群，影响程度前所未有。已经获得了使用巴西绿色芦荟标准化提取物（EPP-AF）对抗病毒靶点的实验证据，并且已经证明了将该提取物作为受COVID-19影响的患者的辅助治疗的临床合理性。BeeCovid 2研究旨在评估EPP-AF是否通过缩短住院时间对COVID-19住院患者的改善产生影响。BeeCovid 2是一项在巴西进行的随机、双盲、安慰剂对照临床研究，旨在提供关于标准化绿色枸杞提取物作为COVID-19住院成人预防治疗有效性的进一步证据。纳入了确诊为COVID-19且症状最长达14天的18岁以上住院患者。随机化时接受机械通气的患者、孕妇、癌症患者、移植或使用免疫抑制剂的患者、HIV患者、在过去30天内使用过顺铂的患者、随机化时细菌或真菌感染、无法口服或肠内用药以及晚期慢性疾病（例如，晚期心力衰竭、严重肝病和终末期慢性肾病）。入选的患者以1：1的比例随机接受安慰剂或标准化的黄芪提取物（900 mg/天），持续10天。研究治疗以双盲方式施用，并对患者随访28天。主要结局是两组间住院天数的差异。次要结局包括是否需要机械通气、继发感染率、急性肾损伤率、是否需要肾脏替代治疗、是否需要血管活性药物、是否使用主动脉内球囊反搏（IABP）和是否使用体外膜肺氧合（ECMO）。这项试验非常有用，将提供更多关于使用标准化巴西绿色枸杞提取物作为预防性治疗与标准护理相结合对患有中度至重度急性COVID-19的住院成人的有效性的数据。ClinicalTrials.gov NCT 04800224。于2021年3月16日注册。
The 2019 coronavirus disease (COVID-19) pandemic continues to spread and affects large numbers of people with unprecedented impacts. Experimental evidence has already been obtained for use of the standardized extract of Brazilian green propolis (EPP-AF) against viral targets, and clinical rationality has been demonstrated for testing this extract as an adjunct to treatment in patients affected by COVID-19. The BeeCovid2 study aims to assess whether EPP-AF has an impact on the improvement of patients hospitalized with COVID-19 by reducing the length of hospital stay. BeeCovid2 is a randomized, double-blinded, placebo-controlled clinical study being conducted in Brazil to provide further evidence on the effectiveness of standardized green propolis extract as an adjunctive treatment for adults hospitalized with COVID-19. Hospitalized patients over 18 years of age with a confirmed diagnosis of COVID-19 and up to 14 days of symptoms were included. Patients under mechanical ventilation at randomization, pregnant women, cancer patients, transplanted or using immunosuppression, HIV patients, patients who used propolis in the last 30 days, bacterial or fungal infection at randomization, impossibility of using medication orally or enterally, and advanced chronic diseases (e.g., advanced heart failure, severe liver disease, and end-stage chronic kidney disease). Enrolled patients are randomized at a 1:1 ratio to receive placebo or standardized propolis extract (900 mg/day) for 10 days. The study treatments are administered in a double-blinded manner, and patients are followed for 28 days. The primary outcome is the difference in length of hospital stay in days between groups. Secondary outcomes include the need for mechanical ventilation, the rate of secondary infection, rate of acute kidney injury, the need for renal replacement therapy, the requirement for vasoactive drugs, the use of an intra-aortic balloon pump (IABP), and the use of extracorporeal membrane oxygenation (ECMO). This trial is very useful and will provide more data on the effectiveness of using the standardized Brazilian green propolis extract as an adjunctive treatment in association with standard care in adults hospitalized with moderate to severe acute COVID-19. ClinicalTrials.gov NCT04800224. Registered on March 16, 2021.
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影响因子：
4.6
作者：
Silveira MAD;Capcha JMC;Sanches TR;de Sousa Moreira R;Garnica MS;Shimizu MH;Berretta A;Teles F;Noronha IL;Andrade L
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1.9
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64.5
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通讯作者：
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影响因子：
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