COVIDPhase 4NCT04530448

Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization

A Phase 4 study testing Sodium bicarbonate in people with COVID and Coronavirus, run by West Virginia University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID, Coronavirus, Coronavirus Infection
What is being tested?: Sodium bicarbonate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 5 Oct 2020to 15 Jul 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 ICU or step-down unit
Age ≥ 18 years old

Who cannot join

Stage 3 AKI by KDIGO criteria
CKD stage 4-5
Contraindications to Na bicarbonate therapy (e.g. met. alkalosis, severe heart failure)
Urine pH > 7.0

Trial locations and contacts

1 site in 1 country.

United States1 site

WVU Medicine Heart & Vascular Institute
Morgantown, West Virginia, 26506

Other trials in United States

About this study

Our overarching goal is to improve the outcomes of critically ill COVID-19 patients with or at risk for development of acute kidney injury (AKI). The objective of this study is to determine the role of a protocol to manage urine alkalization using a simple medication that has been used for a very long time, is safe, and without significant side-effects. We aim to determine the feasibility and safety of a urine alkalinization protocol for the prevention of AKI in patients testing positive for COVID-19.

Read the detailed description

Emerging evidence suggests that acute kidney injury (AKI) secondary to COVID-19 (COV-AKI) might result from direct infection of renal tubule epithelial cells (RTEC). A variety of epithelial cells express the ACE2 receptor which contains the receptor-binding domain (RBD) used by SARS-CoV-1 and SARS-CoV-2 to enter the cells. While direct infection of RTEC has not yet been proven data from multiple laboratories show virus in the kidney. It is this direct viral involvement of the RTEC that this proposal seeks to address.

One relatively simple approach would be to perturb the ability of the RBD to bind to its cellular (hACE2) receptor. Changes in pH may cause each amino acid residue, in the RBD, to assume a slightly different 'microscopic' conformation-dependent pKa value. Urine pH is normally 5.5- 6.5 (not too dissimilar to alveolar fluid-6.4-6.86) and can be easily and safely manipulated. In fact, urine alkalinization protocols have been used for decades to reduce renal toxicity from various compounds (especially chemotherapy) and are recommended by US and European toxicology societies. Here, the strategy will be deployed not for ion trapping but to inhibit the virus from infecting RTEC. Alkalinizing the urine using IV sodium-bicarbonate solution to pH of 7.5 or more can be easily and safely achieved.

While severe AKI does not appear to be a major part of the SARS-CoV-2 syndrome for most patients, when severe AKI does occur, mortality is very high and preventing early AKI may reduce AKI severity as the disease progresses.

Conditions: COVID, Coronavirus, Coronavirus Infection, AKI, Acute Kidney Injury
Being tested: Sodium bicarbonate, Standard of Care
Keywords: Acute Kidney Injury, AKI, COVID-19, Coronavirus, Sodium Bicarbonate
Medical subject headings: Coronavirus Infections, Acute Kidney Injury, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium bicarbonateDrug
Sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours.
Standard of CareOther
Standard of Care treatment

Study groups in NCT04530448
Study group	Role	What they receive
Standard of Care	Active comparator	Standard of Care treatment Receives: Other: Standard of Care
Sodium Bicarbonate	Active comparator	Sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours. Receives: Drug: Sodium bicarbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

pH
Primary feasibility outcome will be the proportion of patients treated who achieve >50% of urine measurements pH ≥= 7.2 over the duration of treatment.
Measured: 10 days
Number of Days Alive Free of Stage 2-3 AKI
Primary efficacy outcome will be the number of days alive and free of stage 2-3 AKI (up to 28) in each group.
Measured: 28 days post-treatment

Secondary outcomes (3)

Stage 2-3 AKI
proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment).
Measured: 28 days
Vent-Free
Ventilator-free days to 28 days
Measured: 28 days
Hospital-Free
Hospital-free days to 60 days
Measured: 60 days post-index hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 202015 Jul 2021

First posted28 Aug 2020
Study start5 Oct 2020
Primary completion15 Jul 2021
Study completion15 Jul 2021

Why it stopped: Unable to recruit enough subjects to complete the study. Only 3 subjects enrolled. However, those subjects did not complete the study as the PI terminated the study and data was not collected.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (23)Papers the sponsor has linked to this study.
Other trials for COVIDStudies of the same condition, open and under way.
More trials run by West Virginia UniversityThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Group 1 (control) will receive standard of care treatment for coronavirus according to institutional protocols. Group 2 (treatment) will receive sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour.
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04530448
Sponsor's protocol ID: 2005006707
Status last verified: Dec 2023
First submitted: 20 Aug 2020
Last updated: 22 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
PubMed 32191259
Ali T, Khan I, Simpson W, Prescott G, Townend J, Smith W, Macleod A. Incidence and outcomes in acute kidney injury: a comprehensive population-based study. J Am Soc Nephrol. 2007 Apr;18(4):1292-8. doi: 10.1681/ASN.2006070756. Epub 2007 Feb 21.
PubMed 17314324
Al-Jaghbeer M, Dealmeida D, Bilderback A, Ambrosino R, Kellum JA. Clinical Decision Support for In-Hospital AKI. J Am Soc Nephrol. 2018 Feb;29(2):654-660. doi: 10.1681/ASN.2017070765. Epub 2017 Nov 2.
PubMed 29097621
Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
PubMed 26162677
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570
Wang HE, Muntner P, Chertow GM, Warnock DG. Acute kidney injury and mortality in hospitalized patients. Am J Nephrol. 2012;35(4):349-55. doi: 10.1159/000337487. Epub 2012 Apr 2.
PubMed 22473149
Ponte B, Felipe C, Muriel A, Tenorio MT, Liano F. Long-term functional evolution after an acute kidney injury: a 10-year study. Nephrol Dial Transplant. 2008 Dec;23(12):3859-66. doi: 10.1093/ndt/gfn398. Epub 2008 Jul 15.
PubMed 18632586
Collister D, Pannu N, Ye F, James M, Hemmelgarn B, Chui B, Manns B, Klarenbach S; Alberta Kidney Disease Network. Health Care Costs Associated with AKI. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1733-1743. doi: 10.2215/CJN.00950117. Epub 2017 Oct 19.
PubMed 29051143
Sakhuja A, Kumar G, Gupta S, Mittal T, Taneja A, Nanchal RS. Acute Kidney Injury Requiring Dialysis in Severe Sepsis. Am J Respir Crit Care Med. 2015 Oct 15;192(8):951-7. doi: 10.1164/rccm.201502-0329OC.
PubMed 26120892
Kellum JA, Prowle JR. Paradigms of acute kidney injury in the intensive care setting. Nat Rev Nephrol. 2018 Apr;14(4):217-230. doi: 10.1038/nrneph.2017.184. Epub 2018 Jan 22.
PubMed 29355173
Tai W, He L, Zhang X, Pu J, Voronin D, Jiang S, Zhou Y, Du L. Characterization of the receptor-binding domain (RBD) of 2019 novel coronavirus: implication for development of RBD protein as a viral attachment inhibitor and vaccine. Cell Mol Immunol. 2020 Jun;17(6):613-620. doi: 10.1038/s41423-020-0400-4. Epub 2020 Mar 19.
PubMed 32203189
Ren X, Glende J, Al-Falah M, de Vries V, Schwegmann-Wessels C, Qu X, Tan L, Tschernig T, Deng H, Naim HY, Herrler G. Analysis of ACE2 in polarized epithelial cells: surface expression and function as receptor for severe acute respiratory syndrome-associated coronavirus. J Gen Virol. 2006 Jun;87(Pt 6):1691-1695. doi: 10.1099/vir.0.81749-0.
PubMed 16690935
Su H, Yang M, Wan C, Yi LX, Tang F, Zhu HY, Yi F, Yang HC, Fogo AB, Nie X, Zhang C. Renal histopathological analysis of 26 postmortem findings of patients with COVID-19 in China. Kidney Int. 2020 Jul;98(1):219-227. doi: 10.1016/j.kint.2020.04.003. Epub 2020 Apr 9.
PubMed 32327202
Imai Y, Kuba K, Rao S, Huan Y, Guo F, Guan B, Yang P, Sarao R, Wada T, Leong-Poi H, Crackower MA, Fukamizu A, Hui CC, Hein L, Uhlig S, Slutsky AS, Jiang C, Penninger JM. Angiotensin-converting enzyme 2 protects from severe acute lung failure. Nature. 2005 Jul 7;436(7047):112-6. doi: 10.1038/nature03712.
PubMed 16001071

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization
ClinicalTrials.gov ID: NCT04530448
Acronym / sponsor ID: 2005006707
Conditions: COVID, Coronavirus, Coronavirus Infection, AKI, Acute Kidney Injury
Keywords: Acute Kidney Injury, AKI, COVID-19, Coronavirus, Sodium Bicarbonate
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unable to recruit enough subjects to complete the study. Only 3 subjects enrolled. However, those subjects did not complete the study as the PI terminated the study and data was not collected.
Enrolment: 3 participants (actual)
Lead sponsor: West Virginia UniversityUniversity, hospital or other
Study start: 5 Oct 2020 (actual)
Primary completion: 15 Jul 2021 (actual)
Study completion: 15 Jul 2021 (actual)
First posted: 28 Aug 2020 (actual)
Results: Posted 22 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Group 1 (control) will receive standard of care treatment for coronavirus according to institutional protocols. Group 2 (treatment) will receive sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour.

Arm	Type	Receives
Standard of Care	Active comparator	Other: Standard of CareStandard of Care treatment
Sodium Bicarbonate	Active comparator	Drug: Sodium bicarbonateSodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Confirmed COVID-19 positive
Admission to ICU or step-down unit
Age ≥ 18 years old

Key exclusion criteria (4 listed)

Stage 3 AKI by KDIGO criteria
CKD stage 4-5
Contraindications to Na bicarbonate therapy (e.g. met. alkalosis, severe heart failure)
Urine pH > 7.0

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 bicarbonateSodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours.	Drug	Sodium Bicarbonate
Standard of CareStandard of Care treatment	Other	Standard of Care

Primary outcome

pH
Time frame: 10 days
Primary feasibility outcome will be the proportion of patients treated who achieve >50% of urine measurements pH ≥= 7.2 over the duration of treatment.
Number of Days Alive Free of Stage 2-3 AKI
Time frame: 28 days post-treatment
Primary efficacy outcome will be the number of days alive and free of stage 2-3 AKI (up to 28) in each group.

3 secondary outcomes

Stage 2-3 AKI
Time frame: 28 days
Vent-Free
Time frame: 28 days
Hospital-Free
Time frame: 60 days post-index hospitalization

Results and safety

Results posted to the registry on 22 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	3	0
Sodium Bicarbonate	0	0

Primary outcome: pH

Time frame: 10 days

Population analysed: Unable to recruit enough subjects to complete the study. Only 3 subjects enrolled. However, those subjects did not complete the study as the PI terminated the study and data was not collected.

Primary outcome: Number of Days Alive Free of Stage 2-3 AKI

Time frame: 28 days post-treatment

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Sodium Bicarbonate	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32191259Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
Background: PubMed 17314324Ali T, Khan I, Simpson W, Prescott G, Townend J, Smith W, Macleod A. Incidence and outcomes in acute kidney injury: a comprehensive population-based study. J Am Soc Nephrol. 2007 Apr;18(4):1292-8. doi: 10.1681/ASN.2006070756. Epub 2007 Feb 21.
Background: PubMed 29097621Al-Jaghbeer M, Dealmeida D, Bilderback A, Ambrosino R, Kellum JA. Clinical Decision Support for In-Hospital AKI. J Am Soc Nephrol. 2018 Feb;29(2):654-660. doi: 10.1681/ASN.2017070765. Epub 2017 Nov 2.
Background: PubMed 26162677Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
Background: PubMed 22473149Wang HE, Muntner P, Chertow GM, Warnock DG. Acute kidney injury and mortality in hospitalized patients. Am J Nephrol. 2012;35(4):349-55. doi: 10.1159/000337487. Epub 2012 Apr 2.
Background: PubMed 18632586Ponte B, Felipe C, Muriel A, Tenorio MT, Liano F. Long-term functional evolution after an acute kidney injury: a 10-year study. Nephrol Dial Transplant. 2008 Dec;23(12):3859-66. doi: 10.1093/ndt/gfn398. Epub 2008 Jul 15.
Background: PubMed 29051143Collister D, Pannu N, Ye F, James M, Hemmelgarn B, Chui B, Manns B, Klarenbach S; Alberta Kidney Disease Network. Health Care Costs Associated with AKI. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1733-1743. doi: 10.2215/CJN.00950117. Epub 2017 Oct 19.
Background: PubMed 26120892Sakhuja A, Kumar G, Gupta S, Mittal T, Taneja A, Nanchal RS. Acute Kidney Injury Requiring Dialysis in Severe Sepsis. Am J Respir Crit Care Med. 2015 Oct 15;192(8):951-7. doi: 10.1164/rccm.201502-0329OC.
Background: PubMed 29355173Kellum JA, Prowle JR. Paradigms of acute kidney injury in the intensive care setting. Nat Rev Nephrol. 2018 Apr;14(4):217-230. doi: 10.1038/nrneph.2017.184. Epub 2018 Jan 22.
Background: PubMed 32203189Tai W, He L, Zhang X, Pu J, Voronin D, Jiang S, Zhou Y, Du L. Characterization of the receptor-binding domain (RBD) of 2019 novel coronavirus: implication for development of RBD protein as a viral attachment inhibitor and vaccine. Cell Mol Immunol. 2020 Jun;17(6):613-620. doi: 10.1038/s41423-020-0400-4. Epub 2020 Mar 19.
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.

Ankit Sakhuja, MD principal investigator

West Virginia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sodium bicarbonate in people with COVID and Coronavirus, run by West Virginia University at 1 site in United States.

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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Dec 2023. 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 States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

pH (time frame: 10 days). 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?

On the ClinicalTrials.gov record for NCT04530448, which also lists 23 linked publications.

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 22 Dec 2023.