Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study

Background: As the number of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infected people is greatly increasing worldwide, the international medical situation becomes very serious. Potential therapeutic drugs, vaccine and stem cell replacement methods are emerging, so it is urgent to find specific therapeutic drugs and the best treatment regimens. After the publications on hydroxychloroquine (HCQ) with anti- SARS-COV-2 activity in vitro, a small, non-randomized, open-label clinical trial showed that HCQ treatment was significantly associated with reduced viral load in patients with coronavirus disease-19 (COVID-19). Meanwhile, a large prophylaxis study of HCQ sulfate for COVID-19 has been initiated in the United States. HCQ offered a promising efficacy in the treatment of COVID-19, but the optimal administration is still being explored. Methods: We used the keyword "hydroxychloroquine" to conduct a literature search in PubMed to collect relevant literature on the mechanism of action of HCQ, its clinical efficacy and safety, pharmacokinetic characteristics, precautions for clinical use and drug interactions to extract and organize information. Results: This paper reviews the mechanism, clinical efficacy and safety, pharmacokinetic characteristics, exposureresponse relationship and precautions and drug interactions of HCQ, and summarizes dosage recommendations for HCQ sulfate. Conclusion: It has been proved that HCQ, which has an established safety profile, is effective against SARS-CoV-2 with sufficient pre-clinical rationale and evidence. Data from high-quality clinical trials are urgently needed worldwide.

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P407 Prospective evaluation of clinical efficacy and safety of golimumab in biologic experienced and naïve patients with moderate to severe ulcerative colitis: experience from a tertiary referral centre

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjx002.532 ◽

2017 ◽

Vol 11 (suppl_1) ◽

pp. S284-S284

Author(s):

B. Orlandini ◽

G. Dragoni ◽

S. Bagnoli ◽

S. Deiana ◽

G. Macrì ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Efficacy ◽

Efficacy And Safety ◽

Prospective Evaluation ◽

Referral Centre ◽

Tertiary Referral ◽

Tertiary Referral Centre ◽

Severe Ulcerative Colitis

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Efficacy and safety of sirolimus treatment for intractable lymphatic anomalies: A study protocol for an open-label, single-arm, multicenter, prospective study (SILA)

Regenerative Therapy ◽

10.1016/j.reth.2018.12.001 ◽

2019 ◽

Vol 10 ◽

pp. 84-91 ◽

Cited By ~ 9

Author(s):

Michio Ozeki ◽

Ryuta Asada ◽

Akiko M. Saito ◽

Hiroya Hashimoto ◽

Takumi Fujimura ◽

...

Keyword(s):

Prospective Study ◽

Study Protocol ◽

Efficacy And Safety ◽

Open Label ◽

Multicenter Prospective Study

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Efficacy and safety of tacrolimus in refractory ulcerative colitis and Crohnʼs disease: A single-center experience

Inflammatory Bowel Diseases ◽

10.1002/ibd.20263 ◽

2008 ◽

Vol 14 (1) ◽

pp. 7-12 ◽

Cited By ~ 67

Author(s):

Aaron Benson ◽

Terrence Barrett ◽

Marshall Sparberg ◽

Alan L. Buchman

Keyword(s):

Ulcerative Colitis ◽

Efficacy And Safety ◽

Single Center ◽

Single Center Experience

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A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial

Trials ◽

10.1186/s13063-020-04876-0 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 1

Author(s):

Timothy Devos ◽

Tatjana Geukens ◽

Alexander Schauwvlieghe ◽

Kevin K. Ariën ◽

Cyril Barbezange ◽

...

Keyword(s):

Treatment Group ◽

Phase Ii ◽

Clinical Efficacy ◽

Active Treatment ◽

Standard Of Care ◽

Active Treatment Group ◽

Proof Of Concept ◽

Efficacy And Safety ◽

Open Label ◽

Open Label Phase

Abstract Background The COVID-19 pandemic has imposed an enormous burden on health care systems around the world. In the past, the administration of convalescent plasma of patients having recovered from SARS and severe influenza to patients actively having the disease showed promising effects on mortality and appeared safe. Whether or not this also holds true for the novel SARS-CoV-2 virus is currently unknown. Methods DAWn-Plasma is a multicentre nation-wide, randomized, open-label, phase II proof-of-concept clinical trial, evaluating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19 in Belgium. Patients hospitalized with a confirmed diagnosis of COVID-19 are eligible when they are symptomatic (i.e. clinical or radiological signs) and have been diagnosed with COVID-19 in the 72 h before study inclusion through a PCR (nasal/nasopharyngeal swab or bronchoalveolar lavage) or a chest-CT scan showing features compatible with COVID-19 in the absence of an alternative diagnosis. Patients are randomized in a 2:1 ratio to either standard of care and convalescent plasma (active treatment group) or standard of care only. The active treatment group receives 2 units of 200 to 250 mL of convalescent plasma within 12 h after randomization, with a second administration of 2 units 24 to 36 h after ending the first administration. The trial aims to include 483 patients and will recruit from 25 centres across Belgium. The primary endpoint is the proportion of patients that require mechanical ventilation or have died at day 15. The main secondary endpoints are clinical status on day 15 and day 30 after randomization, as defined by the WHO Progression 10-point ordinal scale, and safety of the administration of convalescent plasma. Discussion This trial will either provide support or discourage the use of convalescent plasma as an early intervention for the treatment of hospitalized patients with COVID-19 infection. Trial registration ClinicalTrials.govNCT04429854. Registered on 12 June 2020 - Retrospectively registered.

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Clinical Efficacy and Safety of Injection of Stromal Vascular Fraction Derived from Autologous Adipose Tissues in Systemic Sclerosis Patients with Hand Disability: A Proof-Of-Concept Trial

Journal of Clinical Medicine ◽

10.3390/jcm9093023 ◽

2020 ◽

Vol 9 (9) ◽

pp. 3023

Author(s):

Youngjae Park ◽

Yoon Jae Lee ◽

Jung Hee Koh ◽

Jennifer Lee ◽

Hong-Ki Min ◽

...

Keyword(s):

Systemic Sclerosis ◽

Clinical Efficacy ◽

Stromal Vascular Fraction ◽

Skin Fibrosis ◽

Therapeutic Modality ◽

Efficacy And Safety ◽

Open Label ◽

Adipose Tissues ◽

Hand Disability

Background: Stromal vascular fraction (SVF) has recently emerged as a potential therapeutic modality, due to its multipotent cellular components in tissue regeneration. Systemic sclerosis (SSc) is a progressive autoimmune disease that results in hand disability by skin fibrosis and microangiopathies. We performed an open-label study to investigate the efficacy and safety of SVF injection in SSc patients (Clinical Trial number: NCT03060551). Methods: We gathered 20 SSc patients with hand disability, planning for a 24-week follow-up period. SVF was extracted from autologous adipose tissues, processed by the closed system kit, and injected into each finger of SSc patients. We observed various efficacy and safety profiles at each follow-up visit. Results: Among the 20 initially enrolled patients, eighteen received SVF injection, and were completely followed-up for the whole study period. Patients received 3.61 × 106 mesenchymal stem cells into each finger on average. Skin fibrosis, hand edema, and quality of life were significantly improved, and 31.6% of active ulcers were healed at 24 weeks after injections. Semiquantitative results of nailfold capillary microscopy were ameliorated. There was no single serious adverse event related to the procedure. Conclusions: Injection of SVF derived from autologous adipose tissues is tolerable, and shows clinical efficacy in SSc patients.

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