COVID-19Phase 2NCT04410354
Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19
A Phase 2 study testing Merimepodib and Remdesivir in people with COVID-19, run by ViralClear Pharmaceuticals, Inc. at 10 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral solution when administered in combination with remdesivir in adult patients with advanced COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Merimepodib and Remdesivir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 Jun 2020to 1 Dec 2020
- Phase
- Phase 2
- 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
- At least 18 years old
- Confirmed SARS-CoV-2 viral infection
- Advanced COVID-19 with score of 3 or 4 on NIAID scale (first 40 patients) or score of 3 on NIAID scale (last 40 patient
- Has at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath, confusion or severe lower respiratory symptoms
- Off antiviral medications at least 24 hours prior to first dose of study drug (except for remdesivir)
- Able to provide consent
- Agree to appropriate methods of contraception
Who cannot join
- In critical condition or has ARDS
- On invasive mechanical ventilation or ECMO
- Bacterial or fungal infection
- Pregnant or lactating (women)
- ALT >5x ULN, bilirubin >2x ULN, INR outside of normal limits at screening
- eGFR <30 mL/min
Show all 11Show fewer
- Clinically relevant serious co-morbid medical conditions
- Treatment with any immunosuppressive therapy within 30 days prior to screening
- Treatment with another investigational drug within 30 days or 5 half-lives of drug prior to screening
- Prior treatment with the study drug (MMPD) or treatment with remdesivir more than 24 hours prior to the first randomized dose of study drug
- Known hypersensitivity to the inactive ingredients in the study drug (MMPD or placebo) or any ingredient of remdesivir
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
St. David's South Austin Medical Center
Austin, Texas, 78704
St. David's Medical Center
Austin, Texas, 78705
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, 07960
Mayo Clinic in Arizona
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
Atlantic Health System / Overlook Medical Center
Summit, New Jersey, 07901
HCA Houston Healthcare Mainland
Texas City, Texas, 77591
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination With Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)
The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral solution when administered in combination with remdesivir in adult patients with advanced COVID-19.
Read the detailed description
This phase 2 randomized, double-blind, placebo-controlled study will enroll approximately 80 adult patients with advanced coronavirus disease 2019 (COVID-19). Approximately 80 patients will be randomized 1:1 to receive oral administration of MMPD + remdesivir or placebo + remdesivir. The first 40 patients will have a score of 3 or 4 on the National Institute of Allergy and Infectious Disease (NIAID) 8-point ordinal scale and at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion or symptoms of severe lower respiratory symptoms; the final 40 patients will have a score of 3 on the NIAID scale.
Study subjects will undergo screening evaluations prior to the first dose of study drug. Study drug treatment (MMPD or placebo) will continue for 10 days, unless the patient is discharged from the hospital before completing the 10-day randomized treatment period. Both treatment arms will also receive remdesivir per the Emergency Use Authorization labeling. Evaluations will be performed on Days 0-10 and every day thereafter until the subject no longer requires any form of respiratory support or they reach the last planned day of in-person study assessments and still require respiratory support. The final in-person study evaluations will be performed 4 weeks after completion of study drug (MMPD or placebo) treatment (Day 37). The final study evaluation will be a telephone call on Day 56.
- Conditions
- COVID-19
- Being tested
- Merimepodib, Matching Placebo, Remdesivir
- Keywords
- Coronavirus, Advanced Coronavirus Disease 2019, SARS-Cov-2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MerimepodibDrug
Also called VX-497
400 mg (total daily dose of 1200 mg) for 10 days
Matching PlaceboDrug
0 mg (total daily dose of 0 mg) for 10 days
RemdesivirDrug
200 mg loading dose on Day 0 followed by 100 mg daily dose for 4 days. If a subject does not demonstrate clinical improvement, 100 mg daily dose may be extended for up to 5 additional days (for a total of up to 10 days)
| Study group | Role | What they receive |
|---|---|---|
| MMPD + remdesivir | Active comparator | Study subjects will receive MMPD oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days). Receives: Drug: Merimepodib; Drug: Remdesivir |
| Placebo + remdesivir | Placebo comparator | Study subjects will receive matching placebo oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days). Receives: Drug: Matching Placebo; Drug: Remdesivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects not hospitalized or, if hospitalized, free of respiratory failure
Proportion of subjects alive at Day 28 who are not hospitalized or if hospitalized are free of respiratory failure
Measured: Day 0 to Day 28
Adverse Events
Number of Adverse Events (AEs) and number \& percentage of subjects experiencing AEs after administration of the first dose of study drug
Measured: Day 0 to Day 56
Secondary outcomes (8)
National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale
Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities
Measured: Day 0 to Day 28
Temperature
Duration of fever
Measured: Day 0 to Day 37
Death
Number of deaths
Measured: Day 0 to Day 56
Mechanical ventilation
Need and duration of mechanical ventilation
Measured: Day 0 to Day 56
Vasopressor Support
Duration of vasopressor support
Measured: Day 0 to Day 56
Oxygen Therapy
Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula
Measured: Day 0 to Day 37
Cessation of Viral Shedding
Time to cessation of viral shedding based on absence of SARS-CoV-2 in a PCR based COVID-19 test
Measured: Day 0 to Day 37
Change in Oxygen Saturation/Fraction of Inspired Oxygen
Change in SpO2/FiO2
Measured: Day 0 to Day 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start16 Jun 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Why it stopped: Failure to meet primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible study subjects will be randomized 1:1 to receive oral administration of study drug or placebo. Both treatment arms will also receive remdesivir.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViralClear Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Badley, MD, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410354
- Sponsor's protocol ID
- VC-02-01
- Status last verified
- Dec 2020
- First submitted
- 28 Apr 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination With Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04410354
- Acronym / sponsor ID
- VC-02-01
- Conditions
- COVID-19
- Keywords
- Coronavirus, Advanced Coronavirus Disease 2019, SARS-Cov-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to meet primary endpoint
- Enrolment
- 44 participants (actual)
- Lead sponsor
- ViralClear Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 1 Jun 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.
The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral solution when administered in combination with remdesivir in adult patients with advanced COVID-19.
Detailed description
This phase 2 randomized, double-blind, placebo-controlled study will enroll approximately 80 adult patients with advanced coronavirus disease 2019 (COVID-19). Approximately 80 patients will be randomized 1:1 to receive oral administration of MMPD + remdesivir or placebo + remdesivir. The first 40 patients will have a score of 3 or 4 on the National Institute of Allergy and Infectious Disease (NIAID) 8-point ordinal scale and at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion or symptoms of severe lower respiratory symptoms; the final 40 patients will have a score of 3 on the NIAID scale.
Study subjects will undergo screening evaluations prior to the first dose of study drug. Study drug treatment (MMPD or placebo) will continue for 10 days, unless the patient is discharged from the hospital before completing the 10-day randomized treatment period. Both treatment arms will also receive remdesivir per the Emergency Use Authorization labeling. Evaluations will be performed on Days 0-10 and every day thereafter until the subject no longer requires any form of respiratory support or they reach the last planned day of in-person study assessments and still require respiratory support. The final in-person study evaluations will be performed 4 weeks after completion of study drug (MMPD or placebo) treatment (Day 37). The final study evaluation will be a telephone call on Day 56.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Eligible study subjects will be randomized 1:1 to receive oral administration of study drug or placebo. Both treatment arms will also receive remdesivir.
| Arm | Type | Receives |
|---|---|---|
| MMPD + remdesivir | Active comparator | Drug: Merimepodib, Drug: RemdesivirStudy subjects will receive MMPD oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days). |
| Placebo + remdesivir | Placebo comparator | Drug: Matching Placebo, Drug: RemdesivirStudy subjects will receive matching placebo oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years old
- Confirmed SARS-CoV-2 viral infection
- Advanced COVID-19 with score of 3 or 4 on NIAID scale (first 40 patients) or score of 3 on NIAID scale (last 40 patient
- Has at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath, confusion or severe lower respiratory symptoms
- Off antiviral medications at least 24 hours prior to first dose of study drug (except for remdesivir)
Key exclusion criteria (11 listed)
- In critical condition or has ARDS
- On invasive mechanical ventilation or ECMO
- Bacterial or fungal infection
- Pregnant or lactating (women)
- ALT >5x ULN, bilirubin >2x ULN, INR outside of normal limits at screening
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 |
|---|---|---|
| MerimepodibAlso: VX-497400 mg (total daily dose of 1200 mg) for 10 days | Drug | MMPD + remdesivir |
| Matching Placebo0 mg (total daily dose of 0 mg) for 10 days | Drug | Placebo + remdesivir |
| Remdesivir200 mg loading dose on Day 0 followed by 100 mg daily dose for 4 days. If a subject does not demonstrate clinical improvement, 100 mg daily dose may be extended for up to 5 additional days (for a total of up to 10 days) | Drug | MMPD + remdesivir, Placebo + remdesivir |
Primary outcome
Number of subjects not hospitalized or, if hospitalized, free of respiratory failure
Time frame: Day 0 to Day 28
Proportion of subjects alive at Day 28 who are not hospitalized or if hospitalized are free of respiratory failure
Adverse Events
Time frame: Day 0 to Day 56
Number of Adverse Events (AEs) and number \& percentage of subjects experiencing AEs after administration of the first dose of study drug
8 secondary outcomes
National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale
Time frame: Day 0 to Day 28
Temperature
Time frame: Day 0 to Day 37
Death
Time frame: Day 0 to Day 56
Mechanical ventilation
Time frame: Day 0 to Day 56
Vasopressor Support
Time frame: Day 0 to Day 56
Oxygen Therapy
Time frame: Day 0 to Day 37
Cessation of Viral Shedding
Time frame: Day 0 to Day 37
Change in Oxygen Saturation/Fraction of Inspired Oxygen
Time frame: Day 0 to Day 37
Results and safety
The study was stopped early (reason given: Failure to meet primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- 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.
Andrew Badley, MD study director
Mayo Clinic
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Merimepodib and Remdesivir in people with COVID-19, run by ViralClear Pharmaceuticals, Inc. at 10 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 7 inclusion and 11 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 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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.
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: Failure to meet primary endpoint). 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?
Number of subjects not hospitalized or, if hospitalized, free of respiratory failure (time frame: Day 0 to Day 28). 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?
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 8 Dec 2020.