A prospective controlled proof-of-concept trial to demonstrate anti-viral effects of oral bromelaine in COVID-19 positive patients.
- Conditions
- COVID-19
- Registration Number
- DRKS00025783
- Lead Sponsor
- RSAPHARM Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 77
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the clinical impact of the treatment with bromelain tablets with regard to COVID-19 symptoms via a patient diary.
- Secondary Outcome Measures
Name Time Method - To assess the clinical improvement of the patient state via a WHO ordinal scale.<br>- To assess the clinical improvement of the patient state via measurement of body temperature and blood oxygen saturation.<br>- To assess the clinical improvement of the patient state via measurement of blood parameters.<br>- To assess the clinical improvement of the patient state via measurement of virus load in nasopharyngeal swabs (Ct value at baseline D1 vs. Ct-values at D4, D7 and D11).<br>- To assess the clinical impact of the treatment with bromelain tablets with regards to Quality of Life.