Diagnosis of SARS-CoV-2 infection documented by a positive PCR test MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Bromelaintabletten hysan, 500 F.I.P.-Einheiten, magensaftresistente Tabletten
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Bromelains
CAS Number: 9001-00-7
Current Spo
Sponsors
URSAPHARM Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria in order to participate in this study: - 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, such as fever, shortness of breath, cough, anosmia (loss of odor), or ageusia (loss of taste). - Enrolment should generally 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. If justified by persistent or increasing Symptoms, this interval can be extended to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must not meet any of the following non-inclusion criteria in order to participate in this study: - 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, any anti-histamine therapy 30 days prior to enrolment - Females who are pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method* until D16,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the treatment with Bromelain tablets in COVID-19 positive patients is to assess the change in Patient reported symptoms.;Secondary Objective: Secondary objectives of the Trial are: - to assess the Clinical improvement of the Patient Status via a WHO ordinal scale - to assess the Clinical improvement of the Patient state via measurement of Body temperature and blood Oxygen Saturation - to assess the Clinical improvement of the Patient state via measurement of blood Parameters - to assess the Clinical improvement of the Patient state via measurement of Virus load in nasopharyngeal swabs (Ct values) - to assess the clincal Impact of the Treatment with Bromelain tablets with regards to Quality of Life ;Primary end point(s): Primary endpoint of the efficacy of Bromelain tablets in COVID-positive patients is the baseline-adjusted course of the median of Symptoms (anosmia, ageusia, fever, cough, sore throat, shortness of breath, coryza, general weakness, headache, aching limbs, loss of appetite, nausea, abdominal pain, vomiting, diarrhoea, conjunctivitis, rash, lymph node swelling, apathy, somnolence) documented over the course of the study (day 1 - day 11). ;Timepoint(s) of evaluation of this end point: COVID-19 symptom severity will be assessed daily (day 1 to day 11). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. baseline-adjusted area under the curve of the total symptom score 2. baseline-adjusted area under the curve of each individual symptom 3. proportion of patients who show a decrease in their baseline-adjusted symptoms score of SARS-CoV-2 within 3 days of treatment 4. change in patient status via measurement of virus load in nasopharyngeal swabs (Ct value at baseline V1 (D1) vs. Ct-values at V2 (D4 +/- 1 day), V3 (D7 +/- 1 day) and V4 (D11 +/- 2 days)). 5. proportion of patients with the presence of a positive PCR-test at V4 (D11 +/- 2 days) (virus load in nasopharyngeal swabs) 6. change in patient status using a 11-category ordinal score as proposed by the WHO 7. baseline-adjusted change in patient status by measurement of temperature (fever) and oxygen saturation of the blood 8. baseline-adjusted Change in patient status via measurement of blood parameters 9. baseline-adjusted change in quality of life as assessed by the SF-36 generic quality of life questionnaire. 10. Treatment emergent adverse Events and adverse drug reactions ;Timepoint(s) of evaluation of this end point: 1) baseline-adjusted area under the curve (day 1 - day 11) 2) baseline-adjusted area under the curve (day 1 - day 11) 3) V2 (D4 +/- 1 day) 4) V1, V2, V4 and V4 5) V4 6) V1, V2, V3, V4, V5, V6 7) V1, V2, V3, V4 8) V1, V2, V3, V4 9) V1, V2, V3, V4 10) over the entire study period (V1 - V6) | — |
Countries
Germany
Contacts
Public ContactContract Research Organization
ClinCompetence Cologne GmbH
Outcome results
None listed