Covid19Phase 3NCT04655716
Urine Alkalinisation to Prevent AKI in COVID-19
A Phase 3 study testing Sodium Bicarbonate 150Meq/L/D5W Inj in people with Covid19, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim is to explore the feasibility and safety of urine alkalinisation in critically ill patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Sodium Bicarbonate 150Meq/L/D5W Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jul 2021to 31 Dec 2022
- Phase
- Phase 3
- 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
Who may be able to join
- Confirmed Covid-19 positive
- Admission to Critical Care Unit
- Bladder catheter in situ
- Central line in place (including PICC line)
- Age ≥18y
- Written informed consent to participate in the study
Who cannot join
- Stage 3 AKI (as defined by KDIGO criteria)
- Chronic kidney disease stage 4 or 5
- Contraindications to NaHCO3 therapy (e.g. risk of serious drug interaction, systemic metabolic alkalosis, congestive heart failure)
- Urine pH > 7.0
- Serum sodium >150mmol/L
- Blood pressure >180/100mgHg
Show all 12Show fewer
- Severe hypokalaemia (K<3.0mmol/L)
- Inability to grant informed consent
- Severe hypocalcaemia (Cai <0.8 mmol/L)
- Pregnant or lactating and breast-feeding women
- Unwilling to use contraception
- Patient is on a medication that may interact with sodium bicarbonate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urine Alkalinisation to Prevent Acute Kidney Injury in COVID-19
The aim is to explore the feasibility and safety of urine alkalinisation in critically ill patients with COVID-19.
Read the detailed description
Severe acute kidney injury appears to a major part of the SARS-CoV-2 syndrome. Preventing early acute kidney injury may reduce severe AKI as the disease progresses. Urine alkalinisation to prevent binding of SARS-COV-2 to renal tubular epithelial cells is a novel concept that could be used to design other therapies to reduce viral binding. Showing feasibility with this safe and available strategy could be the first step toward other related efforts.
- Conditions
- Covid19
- Being tested
- Sodium Bicarbonate 150Meq/L/D5W Inj
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate 150Meq/L/D5W InjDrug
Also called 8.4% sodium bicarbonate intravenous form
Urine alkalinisation will be performed to achieve urine pH 7.5-8.5. Urine alkalinisation will be continued for up to 10 days or until patient is discharged or until primary endpoint is reached. Urine pH will be measured at point of care by dipstick.
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Experimental | Intravenous sodium bicarbonate infusion Receives: Drug: Sodium Bicarbonate 150Meq/L/D5W Inj |
| Standard care | No intervention | Standard of care by the clinical team |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention
proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention
Measured: up to 10 days after intensive care unit admission
Secondary outcomes (4)
number of days alive and free of stage 2-3 AKI (up to day 28) in each group
number of days alive and free of stage 2-3 AKI (up to day 28) in each group
Measured: up to day 28 after randomisation
proportion of patients developing stage 2-3 AKI
proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment)
Measured: up to day 28 after randomisation
ventilator-free days
ventilator-free days
Measured: up to day 28 after randomisation
hospital-free days
hospital-free days
Measured: up to day 60 after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start19 Jul 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlies Ostermann, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655716
- Sponsor's protocol ID
- 283852
- Status last verified
- Mar 2022
- First submitted
- 4 Dec 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Alkalinisation to Prevent Acute Kidney Injury in COVID-19
- ClinicalTrials.gov ID
- NCT04655716
- Acronym / sponsor ID
- 283852
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Dec 2020 (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.
The aim is to explore the feasibility and safety of urine alkalinisation in critically ill patients with COVID-19.
Detailed description
Severe acute kidney injury appears to a major part of the SARS-CoV-2 syndrome. Preventing early acute kidney injury may reduce severe AKI as the disease progresses. Urine alkalinisation to prevent binding of SARS-COV-2 to renal tubular epithelial cells is a novel concept that could be used to design other therapies to reduce viral binding. Showing feasibility with this safe and available strategy could be the first step toward other related efforts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Experimental | Drug: Sodium Bicarbonate 150Meq/L/D5W InjIntravenous sodium bicarbonate infusion |
| Standard care | No intervention | –Standard of care by the clinical team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed Covid-19 positive
- Admission to Critical Care Unit
- Bladder catheter in situ
- Central line in place (including PICC line)
- Age ≥18y
Key exclusion criteria (12 listed)
- Stage 3 AKI (as defined by KDIGO criteria)
- Chronic kidney disease stage 4 or 5
- Contraindications to NaHCO3 therapy (e.g. risk of serious drug interaction, systemic metabolic alkalosis, congestive heart failure)
- Urine pH > 7.0
- Serum sodium >150mmol/L
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 |
|---|---|---|
| Sodium Bicarbonate 150Meq/L/D5W InjAlso: 8.4% sodium bicarbonate intravenous formUrine alkalinisation will be performed to achieve urine pH 7.5-8.5. Urine alkalinisation will be continued for up to 10 days or until patient is discharged or until primary endpoint is reached. Urine pH will be measured at point of care by dipstick. | Drug | Sodium bicarbonate |
Primary outcome
proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention
Time frame: up to 10 days after intensive care unit admission
proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention
4 secondary outcomes
number of days alive and free of stage 2-3 AKI (up to day 28) in each group
Time frame: up to day 28 after randomisation
proportion of patients developing stage 2-3 AKI
Time frame: up to day 28 after randomisation
ventilator-free days
Time frame: up to day 28 after randomisation
hospital-free days
Time frame: up to day 60 after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Marlies Ostermann principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Bicarbonate 150Meq/L/D5W Inj in people with Covid19, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 6 inclusion and 12 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 15 Mar 2022. 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 United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention (time frame: up to 10 days after intensive care unit admission). 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 15 Mar 2022.