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

Sponsor
Noxopharm Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04555213
Collaborator
(none)
41
Enrollment
1
Location
6
Arms
10.3
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Part 1 Dose Escalation: 400mg, 600mg, 800mg, 1200mg & 1800mg Part 2 Dose Expansion : Recommended Phase 2 DosePart 1 Dose Escalation: 400mg, 600mg, 800mg, 1200mg & 1800mg Part 2 Dose Expansion : Recommended Phase 2 Dose
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19 Infection (NOXCOVID)
Actual Study Start Date :
Sep 30, 2020
Actual Primary Completion Date :
Aug 10, 2021
Actual Study Completion Date :
Aug 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose Escalation Cohort 1 - NOX66 400mg

NOX66 400 mg suppository OD

Drug: NOX66
NOX66 Suppository
Experimental: Dos Escalation Cohort 2 - NOX66 600mg

NOX66 600 mg suppository OD

Drug: NOX66
NOX66 Suppository
Experimental: Dose Escalation Cohort 3 - NOX66 800mg

NOX66 800 mg daily (400 mg suppository BID)

Drug: NOX66
NOX66 Suppository
Experimental: Dose Escalation Cohort 4 - NOX66 1200mg

NOX66 1200 mg daily (600 mg suppository BID)

Drug: NOX66
NOX66 Suppository
Experimental: Dose Escalation Cohort 5 - NOX66 1800mg

NOX66 1800 mg daily (600 mg suppository TID)

Drug: NOX66
NOX66 Suppository
Experimental: Dose Expansion - NOX66 Recommended Phase 2 Dose

Dose Expansion: NOX66 RP2D

Drug: NOX66
NOX66 Suppository

Outcome Measures

Primary Outcome Measures

  1. Incidence of Treatment-Emergent Adverse Events [60 Days]

    Routine safety monitoring during the study period

Secondary Outcome Measures

  1. Change of National Early Warning Score 2 units from baseline [60 Days]

    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.

  2. Change in WHO-9 point ordinal scale [60 Days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:

  1. 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}.

  2. 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.

  3. 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:

  1. 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.

  2. 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.

  3. 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.

  4. Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents.

  5. Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day.

  6. History of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Emergency Medicine Chisinau Moldova, Republic of

Sponsors and Collaborators

  • Noxopharm Limited

Investigators

  • Study Director: Gisela Mautner, MD, PhD, Noxopharm Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noxopharm Limited
ClinicalTrials.gov Identifier:
NCT04555213
Other Study ID Numbers:
  • NOX66-007
First Posted:
Sep 18, 2020
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Aug 26, 2021