Biological AvailabilityCaDoBioNCT04922996
Bioavailability and Pharmacokinetics of Calcium Dobesilate (Doxium®) in the Nasal Mucosal Tissue, Saliva and Blood of Treated Patients
An observational study of Biological Availability, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Calcium dobesilate (CaD) has been shown to have potential antiviral effects, mediated via its interaction with the heparansulfate (HS) binding site of the viral SARS-CoV-2 spike protein (direct action), necessary for interation with the ACE-2 receptor on human cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biological Availability
- What is being tested?
- Calcium Dobesilate
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Apr 2021to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients already on CaD treatment according to the approved indication of treatment, or patients meeting conditions for CaD treatment
Who may be able to join
- Patients treated with calcium dobesilate (1000-2000mg/day), at any time on treatment or for whom initiation of treatment has been prescribed, for one of its Swiss indications:
- Microangiopathies, in particular diabetic retinopathy.
- Clinical symptoms of chronic venous insufficiency of the legs (pains, cramps, paraesthesia, oedemas, stasis dermatitis), superficial thrombophlebitis in adjuvant treatment.
- Haemorrhoidal syndrome, post-thrombotic syndrome, microcirculatory disorders of arteriovenous origin.
- Male or female
- Aged ≥18 years
- Subject has provided the appropriate written informed consent. Subject must provide written informed consent before any study-specific procedures are performed
Who cannot join
- Known sensitivity to calcium dobesilate
- Currently suffering from or treated for a nasal condition, e.g., a runny, congested nose, nasal infection, or an oral condition, e.g., oral infection, including suspected SARS-CoV-2 infection
- Currently treated with a nasal or an oral product, or any treatment with the same active substance as in CaD (e.g., doxiproct, dicynone)
- Current participation in any other investigational drug study
- Only for patients already on CaD treatment: treatment with CaD initiated within last 7 days only
- Only for patients starting CaD treatment: treatment with CaD within last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CaDoBio (Calcium Dobesilate Bioavailability): a Bioavailability and Pharmacokinetics Research Project to Measure the Concentrations of Calcium Dobesilate (Doxium®) in the Nasal Mucosal Tissue, Saliva and Blood of Treated Patients
Calcium dobesilate (CaD) has been shown to have potential antiviral effects, mediated via its interaction with the heparansulfate (HS) binding site of the viral SARS-CoV-2 spike protein (direct action), necessary for interation with the ACE-2 receptor on human cells. Preliminary pre-clinical results using viral pseudotyped particles demonstrated that CaD reduces the uptake of SARS-CoV-2 spike protein in cultured endothelial cells by more than 50%.
Moreover, CaD is a well-established vasoactive and angioprotective drug improving endothelial dysfunction with a good tolerability profile. CaD strengthens vessels integrity and improves blood flow by acting on multiple parameters, like cytokines levels and signaling by FGF and VEGF. All these parameters may be dysregulated at some stage of Covid-19 pathological evolution, and acting on these could potentially reduce the progression toward severe disease. Based on these data, we hypothesize that CaD could be used as an early treatment for SARS-CoV-2 positive outpatients.
Read more
However, bioavailability data and pharmacokinetics of CaD are not well known, outside of old data on animal models. Being able to show that the drug is present in nasal mucosae and saliva, where the virus is likely to start the infection of the host, would be a first step before studying a possible effect on the disease course on infected patients.
Therefore this project plans to include between 6 and 10 patients, treated with CaD, for whom different nasal, saliva and blood sample will be taken at different timepoints before and after the daily dose of the treatment. Samples will be then analysed to detect and quantify the presence of CaD.
- Conditions
- Biological Availability
- Being tested
- Calcium Dobesilate
- Keywords
- Calcium dobesilate, Biological Availability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium DobesilateDrug
Also called Biological samples
Dosage of calcium dobesilate in different tissues
| Study group | Role | What they receive |
|---|---|---|
| Ongoing | Patients already on calcium dobesilate treatment Receives: Drug: Calcium Dobesilate | |
| New | Patients with approved indication for calcium dobesilate treatment but not already on treatment Receives: Drug: Calcium Dobesilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
CaD presence and concentration in nasal mucosa
Nasal mucosa tissue of calcium dobesilate for patients on treatment as assessed by tandem mass spectrometry in ug/ml
Measured: Day 0
CaD presence and concentration in saliva
Saliva concentrations of calcium dobesilate for patients on treatment as assessed by tandem mass spectrometry in ug/ml
Measured: Day 0
Secondary outcomes (17)
Pharmakokinetic of CaD in plasma for patients on treatment
Calcium dobesilate plasma concentrations in ug/ml for patients on treatment
Measured: Day 0 - before the morning dose
Pharmakokinetic of CaD in plasma for patients on treatment
Calcium dobesilate plasma concentrations in ug/ml for patients on treatment
Measured: Day 0 - 4 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients on treatment
Calcium dobesilate plasma concentrations in ug/ml for patients on treatment
Measured: Day 0 - 8 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 0 - before the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 0- 4 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 0 - 8 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 1 - before the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 1 - 4 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 1- 8 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 3- before the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 3 - 4 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 3- 8 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 7- before the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 7 - 4 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Calcium dobesilate plasma concentrations in ug/ml for patients starting treatment
Measured: Day 7- 8 hours after the morning dose
Correlation between nasal mucosal tissue and plasma concentration for patients on treatment
Ratio in %
Measured: Day 0
Correlation between oral tissue and plasma concentration for patients on treatment
Ratio in %
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start15 Apr 2021
- Primary completion26 May 2021
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AvailabilityStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julien Salamun, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922996
- Sponsor's protocol ID
- 2020-03050
- Acronym
- CaDoBio
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pharmacokinetic data Individual concentrations
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CaDoBio (Calcium Dobesilate Bioavailability): a Bioavailability and Pharmacokinetics Research Project to Measure the Concentrations of Calcium Dobesilate (Doxium®) in the Nasal Mucosal Tissue, Saliva and Blood of Treated Patients
- ClinicalTrials.gov ID
- NCT04922996
- Acronym / sponsor ID
- CaDoBio / 2020-03050
- Conditions
- Biological Availability
- Keywords
- Calcium dobesilate, Biological Availability, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- Aug 2021 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Calcium dobesilate (CaD) has been shown to have potential antiviral effects, mediated via its interaction with the heparansulfate (HS) binding site of the viral SARS-CoV-2 spike protein (direct action), necessary for interation with the ACE-2 receptor on human cells. Preliminary pre-clinical results using viral pseudotyped particles demonstrated that CaD reduces the uptake of SARS-CoV-2 spike protein in cultured endothelial cells by more than 50%.
Moreover, CaD is a well-established vasoactive and angioprotective drug improving endothelial dysfunction with a good tolerability profile. CaD strengthens vessels integrity and improves blood flow by acting on multiple parameters, like cytokines levels and signaling by FGF and VEGF. All these parameters may be dysregulated at some stage of Covid-19 pathological evolution, and acting on these could potentially reduce the progression toward severe disease. Based on these data, we hypothesize that CaD could be used as an early treatment for SARS-CoV-2 positive outpatients.
However, bioavailability data and pharmacokinetics of CaD are not well known, outside of old data on animal models. Being able to show that the drug is present in nasal mucosae and saliva, where the virus is likely to start the infection of the host, would be a first step before studying a possible effect on the disease course on infected patients.
Therefore this project plans to include between 6 and 10 patients, treated with CaD, for whom different nasal, saliva and blood sample will be taken at different timepoints before and after the daily dose of the treatment. Samples will be then analysed to detect and quantify the presence of CaD.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ongoing | – | Drug: Calcium DobesilatePatients already on calcium dobesilate treatment |
| New | – | Drug: Calcium DobesilatePatients with approved indication for calcium dobesilate treatment but not already on treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients already on CaD treatment according to the approved indication of treatment, or patients meeting conditions for CaD treatment
Key inclusion criteria (7 listed)
- Patients treated with calcium dobesilate (1000-2000mg/day), at any time on treatment or for whom initiation of treatment has been prescribed, for one of its Swiss indications:
- Male or female
- Aged ≥18 years
- Subject has provided the appropriate written informed consent. Subject must provide written informed consent before any study-specific procedures are performed
Key exclusion criteria (6 listed)
- Known sensitivity to calcium dobesilate
- Currently suffering from or treated for a nasal condition, e.g., a runny, congested nose, nasal infection, or an oral condition, e.g., oral infection, including suspected SARS-CoV-2 infection
- Currently treated with a nasal or an oral product, or any treatment with the same active substance as in CaD (e.g., doxiproct, dicynone)
- Current participation in any other investigational drug study
- Only for patients already on CaD treatment: treatment with CaD initiated within last 7 days only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium DobesilateAlso: Biological samplesDosage of calcium dobesilate in different tissues | Drug | New, Ongoing |
Primary outcome
CaD presence and concentration in nasal mucosa
Time frame: Day 0
Nasal mucosa tissue of calcium dobesilate for patients on treatment as assessed by tandem mass spectrometry in ug/ml
CaD presence and concentration in saliva
Time frame: Day 0
Saliva concentrations of calcium dobesilate for patients on treatment as assessed by tandem mass spectrometry in ug/ml
17 secondary outcomes
Pharmakokinetic of CaD in plasma for patients on treatment
Time frame: Day 0 - before the morning dose
Pharmakokinetic of CaD in plasma for patients on treatment
Time frame: Day 0 - 4 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients on treatment
Time frame: Day 0 - 8 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 0 - before the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 0- 4 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 0 - 8 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 1 - before the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 1 - 4 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 1- 8 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 3- before the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 3 - 4 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 3- 8 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 7- before the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 7 - 4 hours after the morning dose
Pharmakokinetic of CaD in plasma for patients starting treatment
Time frame: Day 7- 8 hours after the morning dose
Correlation between nasal mucosal tissue and plasma concentration for patients on treatment
Time frame: Day 0
Correlation between oral tissue and plasma concentration for patients on treatment
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: Undecided. Pharmacokinetic data Individual concentrations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biological Availability, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CaD presence and concentration in nasal mucosa (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.