Symptoms of Covid-19 infection MedDRA version: 20.0 Level: LLT Classification code 10061986 Term: SARS System Organ Class: 100000004862
Conditions
Interventions
Product Name: MRx-4DP0004
Product Code: MRx-4DP0004
Pharmaceutical Form: Capsule
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: Bifidobacterium breve
Other descriptive name: MRx-4DP0004
Sponsors
4D pharma plc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to sign the informed consent in English and comply with the protocol 2. Age 18 years or older 3. Suspected or confirmed COVID-19 as defined by a. Positive RNA test for SARS-CoV-2 OR b. Presenting with symptoms of COVID-19 as determined by the investigator, and c. A score of 4 or 5 on the WHO Ordinal Scale for Clinical Improvement, and d. Oxygen saturation of =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Known valvular heart defects, pulmonary hypertension or heart failure 2. Known cystic fibrosis or chronic obstructive pulmonary disease 3. Known GI fistula or malabsorption syndrome 4. Known allergy to ALL of the following antibiotics: ampicillin AND clindamycin AND imipenem 5. Any other condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the study endpoints 6. Participants requiring prophylactic antibiotic treatment or antibiotics for a pre-existing condition at enrolment or within the 2 days prior to start of study treatment 7. Females who are pregnant or breastfeeding or planning to become pregnant during the study or for 30 days after completion of study treatment 8. Unwilling or unable to follow contraceptive requirements as described in section 4.3.2 9. Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to start of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of MRx-4DP0004 on the clinical outcome of participants with COVID-19 symptoms;Secondary Objective: To determine the safety of MRx-4DP0004 in participants with COVID-19 symptoms;Primary end point(s): Change in mean clinical status score as measured by the WHO Ordinal Scale for Clinical Improvement;Timepoint(s) of evaluation of this end point: Throughout the duration of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Safety and tolerability as measured by adverse events and serious adverse events • Number of participants with a decrease in score of 1, 2 and >2 points on the WHO Ordinal Scale for Clinical Improvement • Number of participants with an increase in score of 1, 2 and >2 points on the WHO Ordinal Scale for Clinical Improvement • Number of participants who have >= 95% oxygen saturation on room air after 14 days of therapy • Time from starting therapy to participants having >= 95% oxygen saturation on room air • Number of participants with an improvement in their risk classification on the National Early Warning Score (NEWS) 2 • Number of participants having a detrimental change in their risk classification on the National Early Warning Score (NEWS) 2 • Number of participants developing a disease state requiring CPAP • Number of participants developing a disease state requiring IPPV • Time from starting therapy to participants requiring CPAP • Time from starting therapy to participants requiring IPPV • Time to discharge • Number of participant deaths;Timepoint(s) of evaluation of this end point: Throughout the duration of the trial | — |
Countries
Ireland, Italy, United Kingdom, United States
Contacts
Public ContactClinical Trials Department
4D pharma plc
Outcome results
None listed