COVID-19Phase 2NCT04452435
Safety and Efficacy of C21 in Subjects With COVID-19
A Phase 2 study testing C21 in people with COVID-19, run by Vicore Pharma AB at 9 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19
- What is being tested?
- C21
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 21 Jul 2020to 13 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure
- Diagnosis of coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test < 4 days before Visit 1 with signs of an acute respiratory infection
- Age > 18 and < 70 years
- CRP > 50 and < 150 mg/l
- Admitted to a hospital or controlled facility (home quarantine is not sufficient)
- In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol
Who cannot join
- 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:
- Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1+2 antigen/antibody (HIV 1+2 Ag/Ab
Show all 17Show fewer
- Positive pregnancy test (see Section 8.2.3)
- 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:
- Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John's Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbiturates)
- Warfarin
- 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)
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
India8 sites
Department of Medicine, Civil Hospital and B J Medical College
Ahmedabad, Gujarat, 380016
Internal Medicine S.L. Raheja Hospital
Mumbai, Maharashtra, 400016
Department of Medicine, Government Medical College and Hospital
Nagpur, Maharashtra, 440003
Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, 411001
Department of Medicine, Noble Hospitals Pvt. Ltd
Pune, Maharashtra
Infectious Disease, Metas Adventist Hospital
Surat, Gujarat, 395001
Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital
Surat, Gujarat, 395010
First Floor Clinical Research Department Rhythm Heart Institute
Vadodara, Gujarat, 290022
United Kingdom1 site
Respiratory Medicine, University College Hospital
London, WC1E 6BT
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Phase 2 Trial Investigating the Safety and Efficacy of C21 in Hospitalised Subjects With COVID-19 Infection Not Requiring Mechanical Ventilation
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.
- Conditions
- COVID-19
- Being tested
- C21, Placebo
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C21Drug
C21
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| C21 100 mg twice daily | Experimental | Oral C21 treatment 100 mg twice daily for 7 days Receives: Drug: C21 |
| Placebo | Placebo comparator | Oral placebo treatment 100 mg twice daily for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Treatment period of 7 days (Day 1 to Day 8)
Secondary outcomes (11)
Change From Baseline in Body Temperature
Change in body temperature from baseline to the average of the last two assessments in the treatment period
Measured: Treatment period of 7 days ((Day 1 to Day 8)
Change From Baseline in IL-6
Change in IL-6 from baseline to the average of the last two assessments during the treatment period
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: Day 1 to end-of-trial (Visit 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start21 Jul 2020
- Primary completion13 Oct 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicore Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orphan Reach Ltd.
- Responsible party
- Sponsor
- Investigators
- Joanna Porter, MD, Principal investigator, Respiratory Medicine, University College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452435
- Sponsor's protocol ID
- VP-C21-006
- Other IDs
- 2020-001502-38
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2020
- Last updated
- 23 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Phase 2 Trial Investigating the Safety and Efficacy of C21 in Hospitalised Subjects With COVID-19 Infection Not Requiring Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04452435
- Acronym / sponsor ID
- VP-C21-006
- Conditions
- COVID-19
- Keywords
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Vicore Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- Orphan Reach Ltd.
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Posted 30 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C21 100 mg twice daily | Experimental | Drug: C21Oral C21 treatment 100 mg twice daily for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboOral placebo treatment 100 mg twice daily for 7 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure
- Diagnosis of coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test < 4 days before Visit 1 with signs of an acute respiratory infection
- Age > 18 and < 70 years
- CRP > 50 and < 150 mg/l
- Admitted to a hospital or controlled facility (home quarantine is not sufficient)
Key exclusion criteria (17 listed)
- 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:
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 |
|---|---|---|
| C21C21 | Drug | C21 100 mg twice daily |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)
Time frame: Treatment period of 7 days (Day 1 to Day 8)
Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period
11 secondary outcomes
Change From Baseline in Body Temperature
Time frame: Treatment period of 7 days ((Day 1 to Day 8)
Change From Baseline in IL-6
Time frame: Treatment period of 7 days (Day 1 to Day 8)
Change From Baseline in IL-10
Time frame: Treatment period of 7 days (Day 1 to Day 8)
Change From Baseline in TNF
Time frame: Treatment period of 7 days (Day 1 to Day 8)
Change From Baseline in CA125
Time frame: Treatment period of 7 days (Day 1 to Day 8)
Change From Baseline in Ferritin
Time frame: Treatment period of 7 days (Day 1 to Day 8)
Number of Subjects Not in Need of Oxygen Supply
Time frame: End-of treatment, Day 7 or 8
Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation
Time frame: Treatment period of 7 days (Day 1 to Day 8)
Time to Need of Mechanical Invasive or Non-invasive Ventilation
Time frame: Treatment period of 7 days
Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation)
Time frame: Treatment period of 7 days (Day 1 to Day 8)
Adverse Events
Time frame: Day 1 to end-of-trial (Visit 9)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joanna Porter, MD principal investigator
Respiratory Medicine, University College Hospital
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C21 in people with COVID-19, run by Vicore Pharma AB at 9 sites in 2 countries.
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 6 inclusion and 17 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 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India, United Kingdom. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.) (time frame: Treatment period of 7 days (Day 1 to Day 8)). 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 23 Jun 2021.