Covid19Phase 3NCT04504734
Bucillamine in Treatment of Patients With COVID-19
A Phase 3 study testing Bucillamine in people with Covid19, run by Revive Therapeutics, Ltd. at 47 sites in 2 countries.
Trial summary
This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- Bucillamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 713 participants
- Where
- 47 sitesin 2 countries
- Study dates
- 27 Nov 2020to 12 Jun 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is within 72 hours from onset of symptoms consistent with COVID 19 at time of study enrollment
- Has at least 2 of the following: fever (oral temperature ≥38°C), cough, shortness of breath, chest x ray changes consistent with COVID-19 at time of screening
- Has peripheral capillary oxygen saturation (SpO2) ≥94 by pulse oximetry at time of screening
- Has either a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-approved rapid diagnostic (e.g., PCR) assay
- Has a score of ≤ 2 on the 8-category NIAID ordinal scale at time of screening
- Agrees to the collection of blood and urine samples, nasopharyngeal (NP) swabs, and non-invasive oxygen monitoring (via pulse oximeter) per protocol
Show all 9Show fewer
- Patient (or their legally authorized representative) is willing and able to provide written informed consent prior to performing study procedures
- Understands and agrees to comply with planned study procedures
- Women of childbearing potential must agree to either abstinence or use at least 1 primary form of contraception not including hormonal contraception from the time of screening through Day 29 following randomization. All subjects of childbearing potential, including males with partners of childbearing potential, must use highly effective methods of birth control defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly. Abstinence is NOT an acceptable method of contraception UNLESS it is the subject's normal practice.
Who cannot join
- Prior history of, or considered to be at risk for, agranulocytosis, nephropathy, liver disease, or interstitial pneumonia
- Serious hepatic disorder (Child-Pugh scores B or C) or alanine transaminase (ALT) or aspartate transaminase (AST) > 5 times the upper limit of normal (ULN) at screening
- Chronic kidney disease (CKD) National Kidney Foundation (NKF) stages 3B - 5 chronic renal dysfunction (estimated glomerular filtration rate [eGFR] <45 mL/min/1.73m2 according to Cockcroft Gault formula)
- Proteinuria ≥ 1+ or ≥ 30 mg on dipstick urinalysis that is confirmed on repeat assessment within 24 hours
- Serum BUN ≥ 2 × ULN or Cr ≥ 2 × ULN
- Leukopenia with absolute granulocyte count < 1500/µL
Show all 14Show fewer
- History of positive Human Immunodeficiency virus (HIV) test or organ transplant
- Receipt of cancer chemotherapy or immunomodulatory drugs including (but not limited to) biologics such as anti-CD20, anti-TNF, anti-IL6; alkylating agents (e.g., cyclophosphamide); antimetabolites (e.g., azathioprine); or chronic corticosteroid use equivalent to prednisone >10 gm/day, during preceding 2 months
- Confirmed positive for influenza at screening
- Confirmed positive for respiratory syncytial virus (RSV) at screening
- Pregnant or breastfeeding
- Current use of, or known allergy to bucillamine or penicillamine (e.g., for Wilson's disease, rheumatoid arthritis)
- Current participation in any other clinical trial of an experimental treatment
- Receipt of any experimental treatment for COVID-19 (herbal/homeopathic, off-label, compassionate use, or trial related) within the 30 days prior to screening
Trial locations and contacts
47 sites in 2 countries.
47 sites in 2 countries
United States46 sites
American Clinical Trials LLC
Acworth, Georgia, 30101
Inquest Clinical Research
Baytown, Texas, 77521
Pharmacorp Clinical Trials Inc.
Charleston, South Carolina, 29412
OnSite Clinical Solutions
Charlotte, North Carolina, 28208
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28277
Quad Clinical Research LLC
Chicago, Illinois, 60643
Novaceut Clinical Research
Clarksville, Tennessee, 37043
C & R Research Services USA
Coral Gables, Florida, 33134
Cullman Clinical Trials
Cullman, Alabama, 35055
Dayton Clinical Research
Dayton, Ohio, 45406
Revive Research Institute Inc.
Farmington Hills, Michigan, 48334
Sweet Hope Research Specialty Inc
Hialeah, Florida, 33016
Encore Medical Research
Hollywood, Florida, 33021
HealthStar Research LLC
Hot Springs, Arkansas, 71913
C & R Research Services USA
Houston, Texas, 77022
Encore Imaging and Medical Research
Houston, Texas, 77065
ASCADA Research
Huntington Beach, California, 92648
Avant Research Associates, LLC
Huntsville, Alabama, 35802
Physicians Quality Care
Jackson, Tennessee, 38305
R & H Clinical Research Inc.
Katy, Texas, 77494
Entrust Clinical Research
Kendall, Florida, 33156
FMC Science
Lampasas, Texas, 76550
Machuca Family Medicine
Las Vegas, Nevada, 89104
Samuel Ross MD Inc.
Los Angeles, California, 90035
Family Practice Center
McAllen, Texas, 78501
Columbus Clinical Services
Miami, Florida, 33125
Verus Clinical Research
Miami, Florida, 33125
Nuren Medical & Research Center
Miami, Florida, 33144
Advance Medical Research Services Corp
Miami, Florida, 33165
Monroe Biomedical Research
Monroe, North Carolina, 28112
Koch Family Medicine
Morton, Illinois, 61550
Amavita Clinical Research
North Miami Beach, Florida, 33169
Amicis Research Center
Northridge, California, 91324
West Valley Research Clinic
Phoenix, Arizona, 85031
SRI International
Plymouth, Michigan, 48170
Optimus Medical Group
San Francisco, California, 94102
Superior Clinical Research
Smithfield, North Carolina, 27577
Great Lakes Research Institute
Southfield, Michigan, 48075
R & H Clinical Research Inc.
Stafford, Texas, 77477
Revival Research Institute LLC
Sterling, Michigan, 48312
C & R Research Services USA
Tampa, Florida, 33614
Prime Global Research
The Bronx, New York, 10456
Renovatio Clinical
The Woodlands, Texas, 77380
Encore Medical Research of Weston LLC
Weston, Florida, 33321
Clinical Site Partners LLC
Winter Park, Florida, 32789
Superior Clinical Research
Yanceyville, North Carolina, 27379
About this study
Official title: Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients With Mild-Moderate COVID-19
This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo. This dose has now been chosen as 600 mg. The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this study. Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days.
Read the detailed description
This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo. This dose has now been chosen as 600 mg. The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this study.
Patients qualifying for study enrollment will initiate therapy as outpatients, under home quarantine. Patients will receive continued standard care of therapy (per study site written policies or guidelines) together with bucillamine and/ or matching placebo for up to 14 days. Dosing should continue until the treatment course is completed or as medically indicated (e.g., deterioration of clinical status and alternative therapy required). If the patient requires hospitalization during the study period, treatment will be discontinued.
Following completion of the treatment course, follow up assessments will be performed by a study nurse 14, 28, 42, and 60 days following the end of treatment.
Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days.
- Conditions
- Covid19
- Being tested
- Bucillamine, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BucillamineDrug
100mg tablets
PlaceboDrug
100mg tablets
BucillamineDrug
200mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Bucillamine low dose | Active comparator | Bucillamine 100 mg 3 times a day (TID) Receives: Drug: Bucillamine |
| Bucillamine high dose | Active comparator | Bucillamine 200 mg 3 times a day (TID) Receives: Drug: Bucillamine |
| Placebo | Placebo comparator | Placebo, 3 times a day (TID) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Frequency of hospitalization or death
Proportion of patients meeting a composite endpoint of hospitalization or death
Measured: From time of first dose through Day 28 following randomization
Secondary outcomes (1)
Safety: Changes in adverse events from baseline to end of study
Number of adverse events
Measured: From time of first dose through Day 28 following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start27 Nov 2020
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Why it stopped: Met definition of futility according to DSMB
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 713 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revive Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504734
- Sponsor's protocol ID
- RT-003
- Status last verified
- Jul 2023
- First submitted
- 4 Aug 2020
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients With Mild-Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04504734
- Acronym / sponsor ID
- RT-003
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Met definition of futility according to DSMB
- Enrolment
- 713 participants (actual)
- Lead sponsor
- Revive Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 7 Aug 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.
This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo. This dose has now been chosen as 600 mg. The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this study. Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days.
Detailed description
This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo. This dose has now been chosen as 600 mg. The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this study.
Patients qualifying for study enrollment will initiate therapy as outpatients, under home quarantine. Patients will receive continued standard care of therapy (per study site written policies or guidelines) together with bucillamine and/ or matching placebo for up to 14 days. Dosing should continue until the treatment course is completed or as medically indicated (e.g., deterioration of clinical status and alternative therapy required). If the patient requires hospitalization during the study period, treatment will be discontinued.
Following completion of the treatment course, follow up assessments will be performed by a study nurse 14, 28, 42, and 60 days following the end of treatment.
Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bucillamine low dose | Active comparator | Drug: BucillamineBucillamine 100 mg 3 times a day (TID) |
| Bucillamine high dose | Active comparator | Drug: BucillamineBucillamine 200 mg 3 times a day (TID) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, 3 times a day (TID) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is within 72 hours from onset of symptoms consistent with COVID 19 at time of study enrollment
- Has at least 2 of the following: fever (oral temperature ≥38°C), cough, shortness of breath, chest x ray changes consistent with COVID-19 at time of screening
- Has peripheral capillary oxygen saturation (SpO2) ≥94 by pulse oximetry at time of screening
- Has either a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-approved rapid diagnostic (e.g., PCR) assay
- Has a score of ≤ 2 on the 8-category NIAID ordinal scale at time of screening
Key exclusion criteria (14 listed)
- Prior history of, or considered to be at risk for, agranulocytosis, nephropathy, liver disease, or interstitial pneumonia
- Serious hepatic disorder (Child-Pugh scores B or C) or alanine transaminase (ALT) or aspartate transaminase (AST) > 5 times the upper limit of normal (ULN) at screening
- Chronic kidney disease (CKD) National Kidney Foundation (NKF) stages 3B - 5 chronic renal dysfunction (estimated glomerular filtration rate [eGFR] <45 mL/min/1.73m2 according to Cockcroft Gault formula)
- Proteinuria ≥ 1+ or ≥ 30 mg on dipstick urinalysis that is confirmed on repeat assessment within 24 hours
- Serum BUN ≥ 2 × ULN or Cr ≥ 2 × ULN
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 |
|---|---|---|
| Bucillamine100mg tablets | Drug | Bucillamine low dose |
| Placebo100mg tablets | Drug | Placebo |
| Bucillamine200mg tablets | Drug | Bucillamine high dose |
Primary outcome
Efficacy: Frequency of hospitalization or death
Time frame: From time of first dose through Day 28 following randomization
Proportion of patients meeting a composite endpoint of hospitalization or death
1 secondary outcome
Safety: Changes in adverse events from baseline to end of study
Time frame: From time of first dose through Day 28 following randomization
Results and safety
The study was stopped early (reason given: Met definition of futility according to DSMB). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
47 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bucillamine in people with Covid19, run by Revive Therapeutics, Ltd. at 47 sites in 2 countries.
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 9 inclusion and 14 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 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Met definition of futility according to DSMB). 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?
Efficacy: Frequency of hospitalization or death (time frame: From time of first dose through Day 28 following randomization). 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 7 Jul 2023.