Safety and Efficacy of C21 in Subjects With COVID-19
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ClinicalTrials.gov Identifier: NCT04452435 |
Recruitment Status :
Completed
First Posted : June 30, 2020
Results First Posted : April 30, 2021
Last Update Posted : June 23, 2021
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Sponsor:
Vicore Pharma AB
Collaborator:
Orphan Reach
Information provided by (Responsible Party):
Vicore Pharma AB
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
COVID-19 |
Interventions |
Drug: C21 Drug: Placebo |
Enrollment | 206 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
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. |
Arm/Group Title | C21 Treatment | Placebo Treatment |
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Oral C21 treatment 100 mg twice daily for 7 days | Oral placebo treatment twice daily for 7 days |
Period Title: Screening | ||
Started | 51 | 55 |
Completed | 51 | 55 |
Not Completed | 0 | 0 |
Period Title: Treatment Period | ||
Started | 51 | 55 |
Completed | 45 | 43 |
Not Completed | 6 | 12 |
Period Title: Follow-up | ||
Started | 45 | 43 |
Completed | 45 | 42 |
Not Completed | 0 | 1 |
Baseline Characteristics
Arm/Group Title | C21 Treatment | Placebo Treatment | Total | |
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Oral C21 treatment 100 mg twice daily for 7 days | Oral placebo treatment twice daily for 7 days | Total of all reporting groups | |
Overall Number of Baseline Participants | 51 | 55 | 106 | |
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[Not Specified]
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 51 participants | 55 participants | 106 participants | |
54.3
(29 to 68)
|
51.1
(22 to 68)
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52.6
(22 to 68)
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 51 participants | 55 participants | 106 participants | |
Female |
13 25.5%
|
13 23.6%
|
26 24.5%
|
|
Male |
38 74.5%
|
42 76.4%
|
80 75.5%
|
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 51 participants | 55 participants | 106 participants | |
Hispanic or Latino |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Not Hispanic or Latino |
51 100.0%
|
55 100.0%
|
106 100.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 51 participants | 55 participants | 106 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
51 100.0%
|
55 100.0%
|
106 100.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
White |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
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0 0.0%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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India | Number Analyzed | 51 participants | 55 participants | 106 participants |
51 | 55 | 106 | ||
Height
Mean (Full Range) Unit of measure: Cm |
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Number Analyzed | 51 participants | 55 participants | 106 participants | |
166.1
(132 to 198)
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166.0
(143 to 188)
|
166.1
(132 to 198)
|
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Weight
Mean (Full Range) Unit of measure: Kg |
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Number Analyzed | 51 participants | 55 participants | 106 participants | |
70.1
(46 to 116)
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69.2
(47 to 112)
|
69.6
(46 to 116)
|
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Body mass index
Mean (Full Range) Unit of measure: Kg/m^2 |
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Number Analyzed | 51 participants | 55 participants | 106 participants | |
25.4
(15 to 41)
|
25.1
(20 to 34)
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25.2
(15 to 41)
|
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Supplemental oxygen use at baseline
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 51 participants | 55 participants | 106 participants | |
29 56.9%
|
32 58.2%
|
61 57.5%
|
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[1]
Measure Description: Number of subjects in use of supplemental oxygen use at baseline
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CRP value ≤ median
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 51 participants | 55 participants | 106 participants | |
24 47.1%
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22 40.0%
|
46 43.4%
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[1]
Measure Description: Number of subjects with baseline CRP value ≤ median
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CRP value > median
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 51 participants | 55 participants | 106 participants | |
21 41.2%
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25 45.5%
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46 43.4%
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[1]
Measure Description: Number of subjects with baseline CRP value > median
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Carl-Johan Dalsgaard |
Organization: | Vicore Pharma |
Phone: | +46 70 975 98 63 |
EMail: | carl-johan.dalsgaard@vicorepharma.com |
Responsible Party: | Vicore Pharma AB |
ClinicalTrials.gov Identifier: | NCT04452435 |
Other Study ID Numbers: |
VP-C21-006 2020-001502-38 ( EudraCT Number ) |
First Submitted: | June 29, 2020 |
First Posted: | June 30, 2020 |
Results First Submitted: | March 24, 2021 |
Results First Posted: | April 30, 2021 |
Last Update Posted: | June 23, 2021 |