A prospective controlled proof-of-concept trial to demonstrate anti-viral effects of oral bromelaine in COVID-19 positive patients. - BromCO

RSAPHARM Arzneimittel GmbH0 个研究点目标入组 77 人开始时间: 2021年7月5日最近更新: 2024年8月19日

试验速览

暂无简介。

•Legally competent patients who are personally capable of giving informed consent and to sign and date the Consent Form prior to any trial related activity,
•- Patients aged from 18 - 60 years
•- Having the diagnosis of SARS-CoV-2 infection documented by a positive PCR test
•- Patients showing at least one of the typical symptoms for COVID-19 disease, either fever, shortness of breath, cough, anosmia (loss of odor), or ageusia (loss of taste).
•- Enrolment should generally be done on the day of availability of positive COVID-19 PCR test result, and on the subsequent day. The interval between sample collection and enrolment should generally not exceed 48 hours*.,
•- For females: non-pregnant, non-lactating with adequate contraception**, until D16 or females unable to bear children (i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period).

•- Patients requiring hospitalization,
•- Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion,
•- No enrolment permitted if COVID-19 testing was performed more than 48 hours ago
•- Being in any relationship or dependence with the Sponsor, CRO and/or Investigator,
•- Patients being hypersensitive/allergic to bromelain, pineapple or any of the other excipients of the investigational drug,
•- Patients with blood coagulation disorders, e.g., haemophilia,
•- Patients treated with anticoagulants or inhibitors of platelet aggregation,
•- Patients being on risk for a serious course of the disease (e.g., insulin-dependent diabetic patients, patients treated with antihypertensive drugs),
•- Inability to understand instructions/study documents,
•- Inability to administer or swallow the tablets
•- Specific vulnerable patients: subjects who are detained or committed to institutions by law court or by legal authorities, such as psychiatric wards, prisons or other state institutions,
•- Any concurrent anti-histamine therapy
•- Females who are pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method until D16

发起方

RSAPHARM Arzneimittel GmbH