Covid19Phase 1NOXCOVIDNCT04555213
A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19
A Phase 1 study testing NOX66 in people with Covid19, run by Noxopharm Limited at 1 site in Moldova.
Trial summary
Phase Ib, open-label, multicenter, study of NOX66, given rectally to hospitalized patients with moderate systemic illness due to COVID-19 infection at high risk of developing severe sepsis / septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- NOX66
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteMoldova
- Study dates
- 30 Sep 2020to 10 Aug 2021
- Phase
- Phase 1
- 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
- Hospitalized patient with clinically diagnosis of SARS-CoV-2 virus infection per World Health Organization criteria including positive nucleic acid test of any specimen (e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to screening.{Other confirmatory test results will be accepted upon approval from Sponsor/CRO Medical Monitor prior to enrolment}.
- Symptoms suggestive of moderate systemic illness with COVID-19, which could include any of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress.
- Clinical signs indicative of moderate systemic COVID-19 illness (with high risk of developing severe ARDS/septic shock) with an aggregate of NEWS-2 score of 4-6 or 3 in one single parameter.
Who cannot join
- Patients who meet any of the following criteria will be disqualified from entering the study:
- Patients who require endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥ 0.5), non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure.
- Presence of any of the following abnormal laboratory values at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 x upper limit of normal (ULN), platelets <50,000/µL.
- Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors in the past 30 days or plans to receive during the study period.
- Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents.
- Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day.
- History of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19 Infection (NOXCOVID)
Phase Ib, open-label, multicenter, study of NOX66, given rectally to hospitalized patients with moderate systemic illness due to COVID-19 infection at high risk of developing severe sepsis / septic shock.
- Conditions
- Covid19
- Being tested
- NOX66
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOX66Drug
NOX66 Suppository
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort 1 - NOX66 400mg | Experimental | NOX66 400 mg suppository OD Receives: Drug: NOX66 |
| Dos Escalation Cohort 2 - NOX66 600mg | Experimental | NOX66 600 mg suppository OD Receives: Drug: NOX66 |
| Dose Escalation Cohort 3 - NOX66 800mg | Experimental | NOX66 800 mg daily (400 mg suppository BID) Receives: Drug: NOX66 |
| Dose Escalation Cohort 4 - NOX66 1200mg | Experimental | NOX66 1200 mg daily (600 mg suppository BID) Receives: Drug: NOX66 |
| Dose Escalation Cohort 5 - NOX66 1800mg | Experimental | NOX66 1800 mg daily (600 mg suppository TID) Receives: Drug: NOX66 |
| Dose Expansion - NOX66 Recommended Phase 2 Dose | Experimental | Dose Expansion: NOX66 RP2D Receives: Drug: NOX66 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Routine safety monitoring during the study period
Measured: 60 Days
Secondary outcomes (2)
Change of National Early Warning Score 2 units from baseline
Measurement of 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness) to assess overall clinical condition.
Measured: 60 Days
Change in WHO-9 point ordinal scale
Assessment of WHO-9 point ordinal scale for clinical improvement (i.e., 0 = uninfected and 8 = death) category ordinal scale of clinical status from admission.
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start30 Sep 2020
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part 1 Dose Escalation: 400mg, 600mg, 800mg, 1200mg \& 1800mg Part 2 Dose Expansion : Recommended Phase 2 Dose
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noxopharm Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gisela Mautner, MD, PhD, Study director, Noxopharm Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555213
- Sponsor's protocol ID
- NOX66-007
- Acronym
- NOXCOVID
- Status last verified
- Aug 2021
- First submitted
- 16 Sep 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19 Infection (NOXCOVID)
- ClinicalTrials.gov ID
- NCT04555213
- Acronym / sponsor ID
- NOXCOVID / NOX66-007
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Noxopharm LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 18 Sep 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.
Phase Ib, open-label, multicenter, study of NOX66, given rectally to hospitalized patients with moderate systemic illness due to COVID-19 infection at high risk of developing severe sepsis / septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Part 1 Dose Escalation: 400mg, 600mg, 800mg, 1200mg \& 1800mg Part 2 Dose Expansion : Recommended Phase 2 Dose
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort 1 - NOX66 400mg | Experimental | Drug: NOX66NOX66 400 mg suppository OD |
| Dos Escalation Cohort 2 - NOX66 600mg | Experimental | Drug: NOX66NOX66 600 mg suppository OD |
| Dose Escalation Cohort 3 - NOX66 800mg | Experimental | Drug: NOX66NOX66 800 mg daily (400 mg suppository BID) |
| Dose Escalation Cohort 4 - NOX66 1200mg | Experimental | Drug: NOX66NOX66 1200 mg daily (600 mg suppository BID) |
| Dose Escalation Cohort 5 - NOX66 1800mg | Experimental | Drug: NOX66NOX66 1800 mg daily (600 mg suppository TID) |
| Dose Expansion - NOX66 Recommended Phase 2 Dose | Experimental | Drug: NOX66Dose Expansion: NOX66 RP2D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized patient with clinically diagnosis of SARS-CoV-2 virus infection per World Health Organization criteria including positive nucleic acid test of any specimen (e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to screening.{Other confirmatory test results will be accepted upon approval from Sponsor/CRO Medical Monitor prior to enrolment}.
- Symptoms suggestive of moderate systemic illness with COVID-19, which could include any of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress.
- Clinical signs indicative of moderate systemic COVID-19 illness (with high risk of developing severe ARDS/septic shock) with an aggregate of NEWS-2 score of 4-6 or 3 in one single parameter.
Key exclusion criteria (7 listed)
- Patients who meet any of the following criteria will be disqualified from entering the study:
- Patients who require endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥ 0.5), non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure.
- Presence of any of the following abnormal laboratory values at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 x upper limit of normal (ULN), platelets <50,000/µL.
- Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors in the past 30 days or plans to receive during the study period.
- Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents.
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 |
|---|---|---|
| NOX66NOX66 Suppository | Drug | Dos Escalation Cohort 2 - NOX66 600mg, Dose Escalation Cohort 1 - NOX66 400mg, Dose Escalation Cohort 3 - NOX66 800mg, Dose Escalation Cohort 4 - NOX66 1200mg, Dose Escalation Cohort 5 - NOX66 1800mg, Dose Expansion - NOX66 Recommended Phase 2 Dose |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 60 Days
Routine safety monitoring during the study period
2 secondary outcomes
Change of National Early Warning Score 2 units from baseline
Time frame: 60 Days
Change in WHO-9 point ordinal scale
Time frame: 60 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
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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.
Gisela Mautner, MD, PhD study director
Noxopharm Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NOX66 in people with Covid19, run by Noxopharm Limited at 1 site in Moldova.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Moldova. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: 60 Days). 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 26 Aug 2021.