Covid19Phase 2/3NCT04729595
Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients.
A Phase 2/3 study testing Tempol in people with Covid19, run by Adamis Pharmaceuticals Corporation at 17 sites in United States.
Trial summary
An Adaptive, Randomized, Double-blind, Placebo-controlled study to examine the Effects of Tempol in subjects with COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Tempol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 17 sitesUnited States
- Study dates
- 1 Sep 2021to 21 Sep 2022
- Phase
- Phase 2/3
- 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
- Subjects 18 years of age and above with at least one risk factor for disease progression (i.e., age≥ 65, hypertension, diabetes, obesity (BMI ≥30 as defined by CDC), cancer, immunodeficiency and in the opinion of the investigator the risk factor is not acutely life-threatening).
- Laboratory confirmed infection of SARS-CoV-2 within 5 days of Baseline/day 1.
- Subjects must meet the severity score of Moderate or greater for two of the first ten symptoms listed in the Patient Reported Outcomes (PRO) at screening.
- Ability to travel to clinic.
- Ability to understand and sign an informed consent form.
- Female subjects of child-bearing potential who are capable of conception must be: post- menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include abstinence, intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject ≥18 years of age and of child bearing potential must agree to practice two acceptable methods of birth control during the study period.
- Ability to swallow a capsule.
- Ability to complete an electronic diary via smartphone or web.
Who cannot join
- Need for hospitalization based on severe or critical symptoms based on CDC guidance.
- Subject in long-term care facility.
- Known hypersensitivity or contra-indication to Tempol.
- Subjects taking STRONG CYP inhibitors (e.g. fluoxetine, itraconazole, quinidine, clarithromycin).
- In the opinion of the investigator, any reason that would make the follow up of the subject impossible during the study treatment and follow up period. Any reason the subject cannot comply with study and study procedures.
- Subjects receiving any other investigational agent within 4 weeks of Baseline/Day 1.
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- Use of non-FDA approved (EUA or full approval)/off label treatments for COVID-19.
- Lactating females.
- History of any known chronic liver or kidney disease.
- Subjects taking drugs with a Narrow Therapeutic Index such as Cyclosporine Digoxin Flecainide Lithium Phenytoin Sirolimus Theophylline, and Warfarin.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Pinnacle Research Group
Anniston, Alabama, 36207
Dayton Clinical Research
Dayton, Ohio, 45406
Doral medical Research
Doral, Florida, 33166
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, 37067
Sarkis Clinical Trials
Gainesville, Florida, 32607
Center for Respiratory and Sleep Medicine
Greenwood, Indiana, 46143
Vilo Research Group
Houston, Texas, 77017
United Memorial Medical Center
Houston, Texas, 77091
R&H Clinical Research
Katy, Texas, 77494
Barrett Clinical
La Vista, Nebraska, 68128
LA Universal Research
Los Angeles, California, 90057
Tandem Clinical Research GI, LLC.
Marrero, Louisiana, 70072
Monroe Biomedical Research
Monroe, North Carolina, 28112
Omega Research Orlando, LLC
Orlando, Florida, 32808
Meridian Clinical Research
Portsmouth, Virginia, 23707
Eastside Research Associates
Redmond, Washington, 98052
Sunrise Research Institute
Sunrise, Florida, 33325
About this study
Official title: A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) in Subjects With COVID-19 Infection
An Adaptive, Randomized, Double-blind, Placebo-controlled study to examine the Effects of Tempol in subjects with COVID-19 infection.
Read the detailed description
Phase 2/3 Adaptive, Randomized, Double-blind, placebo-controlled enrolling high risk subjects with early COVID19 infection with a primary endpoint of limiting hospitalization.
As part of the initial phase 2 portion of the study, 50 COVID positive subjects with comorbidities will be enrolled. Eligible subjects positively diagnosed COVID-19 infection will be randomized 1:1 to receive either Tempol or placebo.
An interim analysis by a DSMB will examine safety and markers of systemic inflammation during a Stage 1 interim analysis. Based on the DSMB adjudication, the Phase 3 portion of the trial will begin with a second interim analysis after enrollment of 124 subjects
This protocol will seek to enroll approximately 248 subjects > 18 years of age diagnosed with COVID-19 infection. All subjects will receive standard of care. As standard of care can vary between institution over time for the treatment of COVID-19; Off label medication use, therapies, devices, and interventions used in standard of care practice for COVID-19 is allowed.
- Conditions
- Covid19
- Being tested
- Tempol, 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.
TempolDrug
Tempol 800 mg capsule will be administered at 400mg (2 capsules) two times daily for fourteen (14) consecutive days.
PlaceboOther
Placebo capsules will be administered orally (2 capsules) two times daily for fourteen (14) consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Tempol (MMB-02) 800 mg per Day (n=124) Receives: Drug: Tempol |
| Placebo | Placebo comparator | Placebo (n=124) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the rate of sustained clinical resolution1 of symptoms of COVID-19
To evaluate the difference in the rate of sustained clinical resolution1 of symptoms of COVID-19 at Day 14 by evaluating the odds ratio of the rate of sustained clinical resolution1 of symptoms of COVID-19 between Tempol + SOC vs placebo + SOC at Day 14.
Measured: 14 Days from the date Randomization/First Dosing.
Secondary outcomes (3)
Safety of Tempol + SOC vs placebo + SOC: Occurrence of Adverse Events/All cause of mortality
To evaluate the safety of Tempol + SOC vs placebo + SOC from Baseline/Day 1 through Day 60 For:
- Occurrence of treatment-emergent adverse events (TEAEs).
- Occurrence of TEAEs leading to withdrawal of study treatment or premature study discontinuation.
- All cause of mortality (death of the patient, from any cause).
Measured: 60 Days from Randomization/First Dosing.
Efficacy of Tempol on preventing hospitalization: Odds ratio of the rate of hospitalization
To evaluate the efficacy of Tempol on preventing hospitalization at Day 14 in subjects with COVID-19 by evaluating the odds ratio of the rate of hospitalization in subjects with COVID-at Day 14 between treatment arms.
Measured: 14 Days from the date Randomization/First Dosing.
Changes in functional status: Post COVID Functional Scale (PCFS)
To evaluate the changes in functional status measured by Post COVID Functional Scale (PCFS) at Baseline/Day1 to Day7, Day 14 and Day 21 by evaluating the difference in the Post COVID Functional Scale (PCFS) measurement between Tempol + SOC vs. placebo + SOC. The scale is measured from 0 - 10, with a higher score being worse.
Measured: 7,14 and 21 Days from the date Randomization/First Dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Sep 2021
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Why it stopped: Study did not demonstrate statistical significance of its primary endpoint of clinical resolution of COVID-19 symptoms at day 14 versus placebo
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, placebo-controlled enrolling high risk subjects with early COVID19 infection.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adamis Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald B Moss, MD, Study director, Adamis Pharmaceutical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729595
- Sponsor's protocol ID
- APC400-03
- Status last verified
- Dec 2022
- First submitted
- 25 Jan 2021
- Last updated
- 6 Dec 2022
- 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) in Subjects With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04729595
- Acronym / sponsor ID
- APC400-03
- Conditions
- Covid19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study did not demonstrate statistical significance of its primary endpoint of clinical resolution of COVID-19 symptoms at day 14 versus placebo
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Adamis Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 28 Jan 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.
An Adaptive, Randomized, Double-blind, Placebo-controlled study to examine the Effects of Tempol in subjects with COVID-19 infection.
Detailed description
Phase 2/3 Adaptive, Randomized, Double-blind, placebo-controlled enrolling high risk subjects with early COVID19 infection with a primary endpoint of limiting hospitalization.
As part of the initial phase 2 portion of the study, 50 COVID positive subjects with comorbidities will be enrolled. Eligible subjects positively diagnosed COVID-19 infection will be randomized 1:1 to receive either Tempol or placebo.
An interim analysis by a DSMB will examine safety and markers of systemic inflammation during a Stage 1 interim analysis. Based on the DSMB adjudication, the Phase 3 portion of the trial will begin with a second interim analysis after enrollment of 124 subjects
This protocol will seek to enroll approximately 248 subjects > 18 years of age diagnosed with COVID-19 infection. All subjects will receive standard of care. As standard of care can vary between institution over time for the treatment of COVID-19; Off label medication use, therapies, devices, and interventions used in standard of care practice for COVID-19 is allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, placebo-controlled enrolling high risk subjects with early COVID19 infection.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Drug: TempolTempol (MMB-02) 800 mg per Day (n=124) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (n=124) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects 18 years of age and above with at least one risk factor for disease progression (i.e., age≥ 65, hypertension, diabetes, obesity (BMI ≥30 as defined by CDC), cancer, immunodeficiency and in the opinion of the investigator the risk factor is not acutely life-threatening).
- Laboratory confirmed infection of SARS-CoV-2 within 5 days of Baseline/day 1.
- Subjects must meet the severity score of Moderate or greater for two of the first ten symptoms listed in the Patient Reported Outcomes (PRO) at screening.
- Ability to travel to clinic.
- Ability to understand and sign an informed consent form.
Key exclusion criteria (10 listed)
- Need for hospitalization based on severe or critical symptoms based on CDC guidance.
- Subject in long-term care facility.
- Known hypersensitivity or contra-indication to Tempol.
- Subjects taking STRONG CYP inhibitors (e.g. fluoxetine, itraconazole, quinidine, clarithromycin).
- In the opinion of the investigator, any reason that would make the follow up of the subject impossible during the study treatment and follow up period. Any reason the subject cannot comply with study and study procedures.
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 |
|---|---|---|
| TempolTempol 800 mg capsule will be administered at 400mg (2 capsules) two times daily for fourteen (14) consecutive days. | Drug | Active Treatment |
| PlaceboPlacebo capsules will be administered orally (2 capsules) two times daily for fourteen (14) consecutive days. | Other | Placebo |
Primary outcome
Difference in the rate of sustained clinical resolution1 of symptoms of COVID-19
Time frame: 14 Days from the date Randomization/First Dosing.
To evaluate the difference in the rate of sustained clinical resolution1 of symptoms of COVID-19 at Day 14 by evaluating the odds ratio of the rate of sustained clinical resolution1 of symptoms of COVID-19 between Tempol + SOC vs placebo + SOC at Day 14.
3 secondary outcomes
Safety of Tempol + SOC vs placebo + SOC: Occurrence of Adverse Events/All cause of mortality
Time frame: 60 Days from Randomization/First Dosing.
Efficacy of Tempol on preventing hospitalization: Odds ratio of the rate of hospitalization
Time frame: 14 Days from the date Randomization/First Dosing.
Changes in functional status: Post COVID Functional Scale (PCFS)
Time frame: 7,14 and 21 Days from the date Randomization/First Dosing.
Results and safety
The study was stopped early (reason given: Study did not demonstrate statistical significance of its primary endpoint of clinical resolution of COVID-19 symptoms at day 14 versus placebo). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ronald B Moss, MD study director
Adamis Pharmaceutical Corporation
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tempol in people with Covid19, run by Adamis Pharmaceuticals Corporation at 17 sites 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 8 inclusion and 10 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 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Study did not demonstrate statistical significance of its primary endpoint of clinical resolution of COVID-19 symptoms at day 14 versus placebo). 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?
Difference in the rate of sustained clinical resolution1 of symptoms of COVID-19 (time frame: 14 Days from the date Randomization/First Dosing.). 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 6 Dec 2022.