Covid-19 with acute respiratory insufficiency MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Sponsors
G. Pohl-Boskamp GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male / female / diverse adult =18 years of age at time of enrolment 2. Laboratory-confirmed SARS-CoV-2 infection (COVID-19) as determined by PCR or antigen test in any defined specimen prior to enrolment; samples of first positive test collected within 8 (for symptomatic patients at the time of test) respectively 14 (for asymptomatic patients at the time of test) calendar days prior to randomisation are accepted. 3. Inpatient admitted to an isolation ward with dyspnoea and / or tachypnoea (e.g. respiratory rate >20/minute) in stable conditions (i.e. without immediate plans for intermediate (IMC) or intensive care unit (ICU) transfer) and a need for supplemental oxygen with low-flow (i.e. up to 5 l/min) nasal cannula according to investigators assessment. 4. Signed informed consent and data protection declaration prior to initiation of any trial procedures 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Acute respiratory distress syndrome (ARDS) at time of inclusion2. 2. Relevant laboratory abnormality (serum liver enzymes (ASAT, ALAT, GGT) >3x upper range of normality) 3. Known hypersensitivity to trial medication or excipients 4. Presence of inflammatory gastrointestinal disease (e.g. Crohn´s Disease, or colitis ulcerosa, diverticulitis or non-infectious acute gastritis) at time of inclusion 5. Presence of acute or recurrent inflammatory disease of the gall bladder and / or biliary ducts at time of inclusion 6. Severe hepatic disease (e.g. liver cirrhosis Child Pugh B or C, ongoing viral hepatitis) at time of inclusion 7. Hereditary fructose intolerance 8. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 ml/min) 9. Only for female patients of childbearing potential: Pregnancy, positive urine pregnancy test on Day 1, breast feeding or no use of effective contraception 10. Active malignancy (active = running or immediately planned treatment options like e.g. surgery, chemo- or radiation therapy) or condition after carcinoma not longer than 2 years without relapse, which would make it in the opinion of the investigator unsafe or unsuitable for the patient to participate in this clinical trial 11. Use of systemic immunosuppressants (except corticosteroids) within 4 weeks before inclusion into the clinical trial 12. Only for female subjects of childbearing potential: Woman who is pregnant or breast feeding, or without effective contraception 13. Patient in another clinical trial with an investigational medicianl product within 30 days before inclusion into the clinical trial 14. Known to be or suspected of being unable to comply with the clinical trial protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history) 15. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial 16. Patient in custody by juridical or official order evidence of an uncooperative attitude 17. Patient, who is a member of the staff of the study centre, staff of the sponsor or CRO, the investigator him- / herself or close relatives of the investigator Note for exclusion criterion no. 10: Watchful waiting of prostate carcinoma is not considered as an active carcinoma provided that the patient is free of symptoms and without therapy regarding the prostate carcinoma. Such a constellation does not fulfil exclusion criterion no. 10. Final decision is at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1. The daily scores of OSS (Ordinal Status Score, i.e. Patient’s Clinical Status) will be summed-up from Day 2 to Day 15, defined as SOSS-14 and Day 1 value will be used as baseline. 2. The number of days from Day 1 (randomisation) until first increase (improvement) by at least two points in OSS compared to Day 1. ;Main Objective: To evaluate the efficacy of orally administered PB432 capsules compared to placebo in hospitalised patients for 14 days in adults with stable COVID-19 with acute respiratory insufficiency;Secondary Objective: To assess the safety of PB432 compared to placebo applied in patients with COVID-19;Timepoint(s) of evaluation of this end point: Day 1 to Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? The Daily Scores of OSS will be summed-up from Day 2 to Day 29, defined as SOSS-28. ? Time to patient satisfies categories 5, 6 or 7 on the above mentioned 7 category ordinal scale. ? Time to discharge from hospital (duration of hospitalisation) ? Time to OSS score =2 (ICU admission / death) ? Mortality ? Percent of patient discharged from hospital till Day 8, 15, 22, 29 ? Proportion of patients SARS-CoV-2 free pharyngeal swabs / sputum samples (virus-free) on Days 8, 15, 22, 29 ? Proportion of patients with interference of daily activities by dyspnoea at least once after discharge ;Timepoint(s) of evaluation of this end point: Day 1 to Day 29 | — |
Countries
Germany
Contacts
Public ContactSen. Director Med. & Clin. Research
G. Pohl-Boskamp GmbH & Co. KG
Outcome results
None listed