A clinical trial to assess the efficacy and safety of PB432 in COVID-19 positive inpatients with acute respiratory problems

Phase 1

• Conditions: Covid-19 with acute respiratory insufficiency; MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-003779-17-DE
• Lead Sponsor: G. Pohl-Boskamp GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-13
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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

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.

Study & Design

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