Clinical trial NCT04729595: Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Covid19
Lead sponsor: Adamis Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2021-01-28
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-blind, placebo-controlled enrolling high risk subjects with early COVID19 infection.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Difference in the rate of sustained clinical resolution1 of symptoms of COVID-19
timeFrame: 14 Days from the date Randomization/First Dosing.
Secondary outcomes:
measure: Safety of Tempol + SOC vs placebo + SOC: Occurrence of Adverse Events/All cause of mortality
timeFrame: 60 Days from Randomization/First Dosing.
measure: Efficacy of Tempol on preventing hospitalization: Odds ratio of the rate of hospitalization
timeFrame: 14 Days from the date Randomization/First Dosing.
measure: Changes in functional status: Post COVID Functional Scale (PCFS)
timeFrame: 7,14 and 21 Days from the date Randomization/First Dosing.
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Los Angeles
country: United States
facility: LA Universal Research
state: California
city: Doral
country: United States
facility: Doral medical Research
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Orlando
country: United States
facility: Omega Research Orlando, LLC
state: Florida
city: Sunrise
country: United States
facility: Sunrise Research Institute
state: Florida
city: Greenwood
country: United States
facility: Center for Respiratory and Sleep Medicine
state: Indiana
city: Marrero
country: United States
facility: Tandem Clinical Research GI, LLC.
state: Louisiana
city: La Vista
country: United States
facility: Barrett Clinical
state: Nebraska
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee, LLC
state: Tennessee
city: Houston
country: United States
facility: Vilo Research Group
state: Texas
city: Houston
country: United States
facility: United Memorial Medical Center
state: Texas
city: Katy
country: United States
facility: R&H Clinical Research
state: Texas
city: Portsmouth
country: United States
facility: Meridian Clinical Research
state: Virginia
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
Study officials:
affiliation: Adamis Pharmaceutical Corporation
name: Ronald B Moss, MD
role: STUDY_DIRECTOR
References: