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

Phase 1

• Conditions: Diagnosis of SARS-CoV-2 infection documented by a positive PCR test; MedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005523-37-DE
• Lead Sponsor: RSAPHARM Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-26
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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 <100 hrs.
- 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).
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 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified