EUCTR2020-002299-11-HU进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, adaptive-design study to assess the safety and efficacy of daily 200 mg fluvoxamine as add-on therapy to standard of care in moderate severity COVID-19 patients
SigmaDrugs Research Ltd.0 个研究点目标入组 100 人开始时间: 2020年6月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males and females 18-80 years of age at screening
- •Hospitalized patients with confirmed SARS-CoV-2 by PCR or known contact of confirmed case with syndrome consistent with coronavirus disease (COVID-19) with PCR pending (positive PCR result should be available prior to randomisation)
- •Moderate cases (at least one of the following criteria is met):
- •-dyspnoea/tachypnoe, respiratory rate 22-29 / min;
- •-with the need for oxygen supplementation;
- •-pulmonary infiltrates on medical imaging
- •Subjects who are able to communicate with the Investigator and research staff, who understand the study, are able to comply with all study procedures, and willing to provide written informed consent prior to the screening examinations
- •NB. Women of childbearing potential should agree to use a highly effective method of contraception throughout the study and up to 3 months afterwards. Male subjects shall agree to effective contraception during the study and for 14 days following the last drug administration.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Mild COVID-19 at randomisation (each of the followings met): no dyspnoe, respiratory rate < 22 / min, no need for oxygen supplementation, no pulmonary infiltrates on medical imaging
- •Severe COVID-19 at randomization (at least one of the followings is met): dyspnoe/tachypnoe - respiratory rate = 30/min; pulmonary murmur with physical examination with oxygen saturation at rest = 93% (without oxygen support) or oxygen requirement with Venturi mask>50%; arterial partial O2 tension (PaO2)/ inhaling O2-fraction (FiO2)=300 Hgmm; multilobular involvement showing on CT or progression of pulmonary infiltrates with 50% within 24-48 hours
- •Critical COVID-19 at randomization (at least one of the following criteria is met): SpO2 = 90%, need for oxygen supplementation: with FiO2>100%; PaO2/FiO2=200Hgmm, acute respiratory distress, requiring mechanical ventilation; radiomorphology of ARDS; shock, including septic shock; other organ dysfunction necessitating ICU admission
- •High-risk patient for progression of COVID-19, as defined by having a calculated pneumonia PORT-score of > 90
- •Concomitant or previous administration of any experimental, non-established COVID-19 therapy, either in off-label indication (of a registered medicinal product) or as a non-registered drug candidate in a clinical trial setting or compassionate use program (or equivalents thereof), EXCEPT therapies recommended by the Magyar Koronavírus Kézikönyv” (Hungarian Coronavirus Manual), and as such, are considered as standard-of-care. Concomittant use of LMWHs can be considered as emerging standard-of-care, and therefore their application is not prohibited
- •Standard of care treatment planned with chloroquine or hydroxychloroquine
- •Any clinically significant abnormality identified during pre-study full physical examination, vital signs, laboratory tests and ECG which is deemed by the Investigator to be incompatible / inappropriate for study participation
- •Known hepatitis B, C, or HIV infection
- •A current or recent history of drug or substance abuse, including alcohol (> 14 units per week), within 3 months prior to screening (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or one shot [25 mL] of spirits)
- •Patients who regularly consume more than 4 cups daily of beverage containing caffeine
- •Current strong smoker as defined by smoking over 10 cigarettes a day, or its equivalent (for one month prior to screening)
- •Positive pregnancy test result for women with childbearing potential at screening
- •Women who are pregnant or nursing, or who are planning to get pregnant within 3 months after the last dose of study drug
- •A history of allergy, intolerance or sensitivity to fluvoxamine or any component of the study drug formulation
- •Closed-angle glaucoma
- •Patients who are assessed as at risk for suicidal intent during screening by psychiatric evaluation (including C-SSRS questionnaire). A score of 15 or higher on the PHQ-9 depression scale at screening.
- •Have undergone surgery or have donated blood within 12 weeks prior to the start of the study
- •A history of bleeding diathesis or other bleeding disorders
- •Participated in any clinical trial involving an investigational drug or investigational device within 1 month preceding study entry, or within 5 terminal half-life of the investigational drug of this previous study
- •A history of (within 5 years from screening visit) or present malignancy, with the exception of resected basal cell ca
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