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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001502-38 | EudraCT Number |
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| Name | Class |
|---|---|
| Orphan Reach Ltd. | INDUSTRY |
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This is a randomised, double-blind, placebo-controlled phase 2 trial investigating the safety and efficacy of C21 in subjects who are hospitalised with COVID-19 infection, but not in need of mechanical invasive or non-invasive ventilation.
In total, approximately 100 subjects will be enrolled and randomised to receive twice daily oral administration of either standard of care (SoC) + placebo (N=50) or SoC + C21 (N=50). Subjects will be treated for 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C21 100 mg twice daily | Experimental | Oral C21 treatment 100 mg twice daily for 7 days |
|
| Placebo | Placebo Comparator | Oral placebo treatment 100 mg twice daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C21 | Drug | C21 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.) | Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period | Treatment period of 7 days (Day 1 to Day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Temperature | Change in body temperature from baseline to the average of the last two assessments in the treatment period | Treatment period of 7 days ((Day 1 to Day 8) |
| Change From Baseline in IL-6 |
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Inclusion Criteria:
Exclusion Criteria:
Any previous experimental treatment for COVID-19
Need for mechanical invasive or non-invasive ventilation
Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days) prior to COVID-19 diagnosis
Participation in any other interventional trial within 3 months prior to Visit 1
Any of the following findings at Visit 1:
Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator
Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial
Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
Treatment with any of the medications listed below within 1 week prior to Visit 1:
Pregnant or breast-feeding female subjects
Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1
Male subjects not willing to use contraceptive methods as described in Section 5.3.1
Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Porter, MD | Respiratory Medicine, University College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, Civil Hospital and B J Medical College | Ahmedabad | Gujarat | 380016 | India | ||
| Infectious Disease, Metas Adventist Hospital |
96 enrolled subjects were screening failures because inclusion criteria 4 was not met.
2 enrolled subjects decided to withdraw from the trial before randomization. 2 subjects died before randomization (pneumonia). The remaining 106 subjects were randomized to trial treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | C21 Treatment | Oral C21 treatment 100 mg twice daily for 7 days |
| FG001 | Placebo Treatment | Oral placebo treatment twice daily for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
| |||||||||||||
| Treatment Period |
| |||||||||||||
| Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | C21 Treatment | Oral C21 treatment 100 mg twice daily for 7 days |
| BG001 | Placebo Treatment | Oral placebo treatment twice daily for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.) | Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period | Full analysis set. A total of 45 subjects in the C21 group and 46 subjects in the placebo group were included in the analysis of the primary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the primary endpoint analysis was that they had no baseline value available. | Posted | Least Squares Mean | 90% Confidence Interval | mg/L | Treatment period of 7 days (Day 1 to Day 8) |
|
From signing of informed consent until end-of-trial visit, 14-19 days.
At each visit, the subject was asked about AEs in an objective manner, e.g., "Have you experienced any problems since the last visit?" No AEs were reported from signing of informed consent until randomization except for 2 fatal SAEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | C21 Treatment | Oral C21 treatment 100 mg twice daily for 7 days | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment | The events had a fatal outcome |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carl-Johan Dalsgaard | Vicore Pharma | +46 70 975 98 63 | carl-johan.dalsgaard@vicorepharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol | Aug 14, 2020 | Mar 24, 2021 | Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan | Sep 10, 2020 | Jun 21, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000711730 | compound 21 |
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| Drug |
Placebo |
|
Change in IL-6 from baseline to the average of the last two assessments during the treatment period
| Treatment period of 7 days (Day 1 to Day 8) |
| Change From Baseline in IL-10 | Change in IL-10 from baseline to the average of the last two assessments during the treatment period | Treatment period of 7 days (Day 1 to Day 8) |
| Change From Baseline in TNF | Change in TNF from baseline to the average of the last two assessments during the treatment period. | Treatment period of 7 days (Day 1 to Day 8) |
| Change From Baseline in CA125 | Change in CA125 from baseline to the average of the last two assessments in the treatment period | Treatment period of 7 days (Day 1 to Day 8) |
| Change From Baseline in Ferritin | Change in Ferritin from baseline to the average of the last two assessments during the treatment period. | Treatment period of 7 days (Day 1 to Day 8) |
| Number of Subjects Not in Need of Oxygen Supply | Number of subjects not in need of oxygen supply at the end of treatment | End-of treatment, Day 7 or 8 |
| Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation | Number of subjects not in need of mechanical invasive or non-invasive ventilation during the treatment period | Treatment period of 7 days (Day 1 to Day 8) |
| Time to Need of Mechanical Invasive or Non-invasive Ventilation | Time to need of mechanical invasive or non-invasive ventilation during treatment period | Treatment period of 7 days |
| Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation) | Time on oxygen supply during the treatment period (for those not needing mechanical invasive or non-invasive ventilation) | Treatment period of 7 days (Day 1 to Day 8) |
| Adverse Events | Adverse events were reported from signing of informed consent until end-of-trial visit. No AEs were reported from signing of informed consent until randomization, except for 2 fatal SAEs described under Adverse events. | Day 1 to end-of-trial (Visit 9) |
| Surat |
| Gujarat |
| 395001 |
| India |
| Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital | Surat | Gujarat | 395010 | India |
| First Floor Clinical Research Department Rhythm Heart Institute | Vadodara | Gujarat | 290022 | India |
| Internal Medicine S.L. Raheja Hospital | Mumbai | Maharashtra | 400016 | India |
| Department of Medicine, Government Medical College and Hospital | Nagpur | Maharashtra | 440003 | India |
| Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic | Pune | Maharashtra | 411001 | India |
| Department of Medicine, Noble Hospitals Pvt. Ltd | Pune | Maharashtra | India |
| Respiratory Medicine, University College Hospital | London | WC1E 6BT | United Kingdom |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Full Range | cm |
|
| Weight | Mean | Full Range | kg |
|
| Body mass index | Mean | Full Range | kg/m^2 |
|
| Supplemental oxygen use at baseline | Number of subjects in use of supplemental oxygen use at baseline | Count of Participants | Participants |
|
| CRP value ≤ median | Number of subjects with baseline CRP value ≤ median | Count of Participants | Participants |
|
| CRP value > median | Number of subjects with baseline CRP value > median | Count of Participants | Participants |
|
Oral placebo treatment twice daily for 7 days |
|
|
|
| Secondary | Change From Baseline in Body Temperature | Change in body temperature from baseline to the average of the last two assessments in the treatment period | Subjects with measurements were included in the analysis for the full analysis set. | Posted | Least Squares Mean | 90% Confidence Interval | °C | Treatment period of 7 days ((Day 1 to Day 8) |
|
|
|
|
| Secondary | Change From Baseline in IL-6 | Change in IL-6 from baseline to the average of the last two assessments during the treatment period | Subjects with measurements were included in the analysis for the full analysis set. | Posted | Least Squares Mean | 90% Confidence Interval | pg/mL | Treatment period of 7 days (Day 1 to Day 8) |
|
|
|
|
| Secondary | Change From Baseline in IL-10 | Change in IL-10 from baseline to the average of the last two assessments during the treatment period | Subjects with measurements were included in the analysis for the full analysis set. | Posted | Least Squares Mean | 90% Confidence Interval | pg/mL | Treatment period of 7 days (Day 1 to Day 8) |
|
|
|
|
| Secondary | Change From Baseline in TNF | Change in TNF from baseline to the average of the last two assessments during the treatment period. | Subjects with measurements were included in the analysis for the full analysis set. | Posted | Least Squares Mean | 90% Confidence Interval | pg/mL | Treatment period of 7 days (Day 1 to Day 8) |
|
|
|
|
| Secondary | Change From Baseline in CA125 | Change in CA125 from baseline to the average of the last two assessments in the treatment period | Subjects with measurements were included in the analysis for the full analysis set. | Posted | Least Squares Mean | 90% Confidence Interval | u/mL | Treatment period of 7 days (Day 1 to Day 8) |
|
|
|
|
| Secondary | Change From Baseline in Ferritin | Change in Ferritin from baseline to the average of the last two assessments during the treatment period. | Subjects with measurements were included in the analysis for the full analysis set. | Posted | Least Squares Mean | 90% Confidence Interval | ng/mL | Treatment period of 7 days (Day 1 to Day 8) |
|
|
|
|
| Secondary | Number of Subjects Not in Need of Oxygen Supply | Number of subjects not in need of oxygen supply at the end of treatment | Full analysis set | Posted | Count of Participants | Participants | End-of treatment, Day 7 or 8 |
|
|
|
|
| Secondary | Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation | Number of subjects not in need of mechanical invasive or non-invasive ventilation during the treatment period | Full analysis set | Posted | Count of Participants | Participants | Treatment period of 7 days (Day 1 to Day 8) |
|
|
|
|
| Secondary | Time to Need of Mechanical Invasive or Non-invasive Ventilation | Time to need of mechanical invasive or non-invasive ventilation during treatment period | Subjects with measurements were included in the analysis for the full analysis set. | Posted | Mean | Full Range | hours | Treatment period of 7 days |
|
|
|
|
| Secondary | Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation) | Time on oxygen supply during the treatment period (for those not needing mechanical invasive or non-invasive ventilation) | Full analysis set | Posted | Median | Inter-Quartile Range | days | Treatment period of 7 days (Day 1 to Day 8) |
|
|
|
|
| Secondary | Adverse Events | Adverse events were reported from signing of informed consent until end-of-trial visit. No AEs were reported from signing of informed consent until randomization, except for 2 fatal SAEs described under Adverse events. | Safety analysis set | Posted | Count of Participants | Participants | Day 1 to end-of-trial (Visit 9) |
|
|
|
| Post-Hoc | Oxygen Supplementation at Day 14 | Number of subjects requiring oxygen supplementation at Day 14 | Full analysis set | Posted | Count of Participants | Participants | Follow-up Day 14 (7 days after end-of-treatment) |
|
|
|
|
| 51 |
| 1 |
| 51 |
| 30 |
| 51 |
| EG001 | Placebo Treatment | Oral placebo treatment twice daily for 7 days | 3 | 55 | 3 | 55 | 36 | 55 |
| EG002 | No Treatment (Before Randomization) | Subjects that were enrolled in the trial but not randomized | 2 | 100 | 2 | 100 | 0 | 100 |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment | The events had a fatal outcome |
|
| Blood glucose increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Interleukin level increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Serum ferritin increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Alpha tumour necrosis factor increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Carbohydrate antigen 125 increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |