Kidney patients needed for early COVID drug study
NCT ID NCT06698549
First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 4 times
Summary
This early study tests how the experimental COVID-19 drug ALG-097558 moves through the body in people with severe kidney problems compared to healthy volunteers. Twelve adults will take multiple doses of the drug. The goal is to see if kidney function affects drug levels and safety, not to test if it treats COVID-19.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ALG-097558
- What this could lead to
- If successful, this study could help determine safe dosing of ALG-097558 for COVID-19 patients with kidney issues.
- What could go wrong
- This is a very early Phase 1 study with only 12 people. It only looks at drug levels and safety, not whether the drug works against COVID-19. Results may not apply to broader populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
12 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for All Subjects: 1. Male and Female between 18 and 75 years old 2. Body Mass Index (BMI) 17.5 to 40.0 kg/m\^2 and a total body weight \>50 kg (110 lb) 3. Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non-sterile, male sexual partners agree to use highly effective contraceptive therapy Inclusion Criteria for Subjects with Normal Renal Function: 1. Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs, clinical laboratory and 12-lead electrocardiogram (ECG) assessment 2. Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender 3. Normal renal function (estimated Glomerular Filtration Rate \[eGFR\] ≥90 mL/min) with no known or suspected renal impairment Inclusion Criteria for Subjects with Impaired Renal Function: 1. Subject satisfies the eGFR criteria for renal impairment classification within 28 days of study drug administration 2. Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included). 3. Stable concomitant medications for the management of an individual subject's medical history for at least 28 days prior to screening 4. Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol criteria Exclusion Criteria for All Subjects: 1. Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results and interpretation 2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant (subjects with normal renal function) or unstable (subjects with renal impairment) cardiac disease etc. 3. Subjects with a history of clinically significant drug allergy 4. Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use 5. Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men 6. Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up 7. Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection 8. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \>2x upper limit of normal (ULN) 9. Subjects with bilirubin (total, direct) \>1.5x ULN (unless Gilbert's is suspected) 10. Positive pregnancy test; females must not be pregnant at enrollment Exclusion Criteria for Subjects with Normal Renal Function: 1\. Hemoglobin \<10 g/dL Exclusion Criteria for Subjects with Impaired Renal Function: 1. Participants requiring hemodialysis and/or peritoneal dialysis 2. Hemoglobin \<9 g/dL
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Genesis Clinical Trials
Tampa, Florida, 33603, United States
-
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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University of Miami
Miami, Florida, 33136, United States
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Other studies related to the condition(s) this trial covers.
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