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A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19 (NOXCOVID)

Primary Purpose

Covid19

Status

Completed

Phase

Phase 1

Locations

Moldova, Republic of

Study Type

Interventional

Intervention

NOX66

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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:

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.

Sites / Locations

Institute of Emergency Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Dose Escalation Cohort 1 - NOX66 400mg

Dos Escalation Cohort 2 - NOX66 600mg

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

Arm Description

NOX66 400 mg suppository OD

NOX66 600 mg suppository OD

NOX66 800 mg daily (400 mg suppository BID)

NOX66 1200 mg daily (600 mg suppository BID)

NOX66 1800 mg daily (600 mg suppository TID)

Dose Expansion: NOX66 RP2D

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events

Routine safety monitoring during the study period

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04555213

First Posted

September 16, 2020

Last Updated

August 24, 2021

Sponsor

Noxopharm Limited

1. Study Identification

Unique Protocol Identification Number

NCT04555213

Brief Title

A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19

Acronym

NOXCOVID

Official Title

A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19 Infection (NOXCOVID)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 30, 2020 (Actual)

Primary Completion Date

August 10, 2021 (Actual)

Study Completion Date

August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Noxopharm Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Part 1 Dose Escalation: 400mg, 600mg, 800mg, 1200mg & 1800mg Part 2 Dose Expansion : Recommended Phase 2 Dose

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation Cohort 1 - NOX66 400mg

Arm Type

Experimental

Arm Description

NOX66 400 mg suppository OD

Arm Title

Dos Escalation Cohort 2 - NOX66 600mg

Arm Type

Experimental

Arm Description

NOX66 600 mg suppository OD

Arm Title

Dose Escalation Cohort 3 - NOX66 800mg

Arm Type

Experimental

Arm Description

NOX66 800 mg daily (400 mg suppository BID)

Arm Title

Dose Escalation Cohort 4 - NOX66 1200mg

Arm Type

Experimental

Arm Description

NOX66 1200 mg daily (600 mg suppository BID)

Arm Title

Dose Escalation Cohort 5 - NOX66 1800mg

Arm Type

Experimental

Arm Description

NOX66 1800 mg daily (600 mg suppository TID)

Arm Title

Dose Expansion - NOX66 Recommended Phase 2 Dose

Arm Type

Experimental

Arm Description

Dose Expansion: NOX66 RP2D

Intervention Type

Drug

Intervention Name(s)

NOX66

Intervention Description

NOX66 Suppository

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events

Description

Routine safety monitoring during the study period

Time Frame

60 Days

Secondary Outcome Measure Information:

Title

Change of National Early Warning Score 2 units from baseline

Description

Time Frame

60 Days

Title

Change in WHO-9 point ordinal scale

Description

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.

Time Frame

60 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gisela Mautner, MD, PhD

Organizational Affiliation

Noxopharm Limited

Official's Role

Study Director

Facility Information:

Facility Name

Institute of Emergency Medicine

City

Chisinau

Country

Moldova, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19

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