COVID-19Phase 3ATTRACT-3NCT04880642
A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects
A Phase 3 study testing C21 in people with COVID-19, run by Vicore Pharma AB at 60 sites in 10 countries.
Trial summary
This trial is a randomized, double-blind, placebo-controlled, parallel-group, 2-arm, multicenter trial to evaluate the efficacy and safety of C21 versus placebo as add-on to standard of care (SoC) in adult subjects with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 272 participants
- Where
- 60 sitesin 10 countries
- Study dates
- 16 Sep 2021to 25 Apr 2022
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years or the legal age of consent in the jurisdiction in which the trial was taking place at the time of signing the informed consent (Specific for India; Age ≥18 to ≤65 years at the time of signing the informed consent)
- Hospitalized due to SARS-CoV-2 infection confirmed by a hospital-approved polymerase chain reaction (PCR) test, documented by either of the following:
- PCR positive in sample collected <72 hours prior to randomization (Visit 2); OR
- PCR positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample AND progressive disease suggestive of ongoing SARS-CoV-2 infection
- A score of 5 or 6 on the 8-point ordinal scale:
- Score 5: Hospitalized, requiring supplemental oxygen
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- Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen device
- Contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies and according to Appendix 3 in the Protocol (see Section 10.3)
- Written informed consent, consistent with International Council for Harmonization Good Clinical Practice Revision 2 and local laws, obtained before the initiation of any trial-related procedure
- Capable of giving signed informed consent as described in Appendix 1 in the Protocol (see Section 10.1.3) which includes compliance with the requirements and restrictions listed in the informed consent form and in this Protocol
- Country specific:
- Specific for India: For subjects with an ordinal scale score of 5, moderate to severe COVID-19 disease confirmed by at an SpO2≤93 % or a respiratory rate≥24/min on room air. Note: If a subject was on supplemental oxygen with SpO2>93% and respiratory rate<24/min, but desaturation to ≤93 % or increase of respiratory rate to ≥24/min on lower supplemental oxygen or room air is documented during screening, the inclusion criterion was considered to be met.
Who cannot join
- Concurrent serious medical condition which in the opinion of the investigator constituted a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation
- Known, active tuberculosis, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 count<500 cells/mm³).
- Moderate or severe impairment of hepatic function (e.g., Child-Pugh class B or C where alterations in the score components were not due to another underlying disease (see Section 8.4.5 in the Protocol)).
- Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR)≤30 ml/min/1.73m2)
- COVID-19 symptom onset >21 days prior to screening (Visit 1).
- Hospitalized due to COVID-19 for >72 hours at screening (Visit 1).
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- Invasive mechanical ventilation or ECMO within 72 hours of screening (Visit 1).
- Expected need for invasive mechanical ventilation or ECMO in <48 hours in the opinion of the investigator
- Moderate to severe ARDS (e.g., same-day PaO2/FiO2 ≤200 mmHg; or SpO2/FiO2 ≤232 if arterial blood gas test is not available), if on non-invasive mechanical ventilation or high-flow oxygen.
- Pregnant or breast-feeding female subjects
- Any previous and concurrent experimental treatment for COVID-19 that was not considered local SoC.
- Treatment with the medications listed below within 1 week prior to screening (Visit 1) or anticipated need for such medication during the participation in this trial:
- Strong Cytochrome P450 (CYP) 3A4 inducers.
- P-glycoprotein (P-gp) substrates with narrow therapeutic index.
- High dose Breast Cancer Resistance Protein (BCRP) sensitive substrates.
- Warfarin.
- Sulphasalazine or rosuvastatin.
- Current or previous participation in any other clinical trial where the subject had received a dose of IMP within 1 month or 5 half-lives of the IMP, whichever was longest, prior to screening (Visit 1).
- Positive pregnancy test (see Section 8.4.6 in the Protocol).
- Abnormal laboratory value at screening (Visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator
Trial locations and contacts
60 sites in 10 countries.
60 sites in 10 countries
India13 sites
Civil Hospital and B J Medical College
Ahmedabad, Gujarat
Chirayu Medical College and Hospital
Bhopal, Madhya Pradesh
Jawaharlal Nehru Institute of Medical Sciences
Imphal, Manipur
Malabar Medical College Hospital and Research Centre
Kozhikode, Kerala
Chettinad Hospital and Research Institute
Mahabalipuram, Chennai
Government Medical College and Hospital
Nagpur, Maharashtra
Meditrina Institute of Medical Sciences
Nagpur, Maharashtra
Smt. Kashibai Navale Medical College and General Hospital
Pune, Gujarat
Noble Hospital
Pune, Maharashtra
Ruby Hall Clinic
Pune, Maharashtra
Rajiv Gandhi Medical College
Thane, Maharashtra
Elite Mission Hospital
Thrissur, Kerala
Rhythm Heart Institute
Vadodara, Gujarat
Ukraine8 sites
City Clinical Hospital №6 of the Dnipro City Council
Dnipro
City Clinical Hospital №13" Of Kharkiv City Council
Kharkiv
Regional Clinical Hospital of Infectious Diseases
Kharkiv
Kyiv city clinical hospital number 12
Kiev
Oleksandrivska Kyiv City Clinical Hospital
Kyiv
Vinnytsia City Clinical Hospital №1
Vinnytsia
Zaporizhzhia Regional Clinical Hospital
Zaporizhia, Zaporizhzhia Oblast
Hospital №1 of Zhytomyr City Council
Zhytomyr
Brazil7 sites
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu
Hospital Brasília
Brasília, 71681-603
Fundação Universidade de Caxias do Sul
Caxias do Sul
Instituto Atena de Pesquisa Clínica
Natal, Rio Grande do Norte
Centro de Pesquisas Clínicas de Natal
Natal, 59025-050
Hospital de Clínicas de Porto Alegre
Porto Alegre
Hospital Alemão Oswaldo Cruz - Paulista
São Paulo, 01323-020
Philippines7 sites
St. Luke's Medical Center - Global City
City of Taguig
Southern Philippines Medical Center
Davao City
The Medical City
Iloilo City, Iloilo
West Visayas State University Medical Center
Iloilo City
Makati Medical Center
Makati
Lung Center of the Philippines
Quezon City
Quirino Memorial Medical Center
Quezon City
United States6 sites
Lehigh Valley Hospital - 17th Street
Allentown, Pennsylvania, 18102
Parkview Physicians Group - Infectious Diseases
Fort Wayne, Indiana, 46805
Trinity Health
Minot, North Dakota, 58701
University of California Irvine Medical Center
Orange, California, 92868
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190
Russia5 sites
Clinical Infectious Disease Hospital 1 of the Moscow Department of Health
Moscow
Alexandrovskaya State Hospital
Saint Petersburg
Nikolaevskaya State Hospital
Saint Petersburg
Pokrovskaya City Hospital
Saint Petersburg
St. Petersburg State Budgetary Healthcare Institution City Hospital Number 40 of the Kurortny District
Saint Petersburg
Argentina4 sites
Nuevo Hospital San Roque
Córdoba
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, X5800
Hospital Italiano Rosario - Centro
Rosario, Santa Fe Province, S2000
Hospital Italiano Rosario
Rosario, Santa Fe Province, S2001
Czechia4 sites
Fakultní Nemocnice u sv. Anny v Brně II. Interní Klinika kardiologická JIP,
Brno, South Moravian
Fakultní Nemocnice u sv. Anny v Brne Number 1
Brno
Nemocnice Slaný
Slaný
Masarykova nemocnice v Ústí nad Labem
Ústí nad Labem
Colombia3 sites
Fundación Santa Fe de Bogotá
Bogotá, Cundinamarca
Hospital Universitario San Ignacio
Bogotá, Cundinamarca
Clinica Somer
Rionegro, Antioquia
South Africa3 sites
TASK Eden
George, Western Cape, 6530
Mediclinic Southern Africa
Tongaat, KwaZulu-Natal, 4400
Tygerberg Hospital
Tygerberg Hills, Western Cape, 7505
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 3, Multicenter Trial Investigating the Efficacy and Safety of C21 as add-on to Standard of Care in Adult Subjects With COVID-19
This trial is a randomized, double-blind, placebo-controlled, parallel-group, 2-arm, multicenter trial to evaluate the efficacy and safety of C21 versus placebo as add-on to standard of care (SoC) in adult subjects with COVID-19.
The trial planned to enroll a total of maximum 300 randomized subjects, 150 per arm (oral C21 100 mg twice a day (BID) or placebo for 14 days) according to the 1:1 randomization.
Read the detailed description
The trial consists of 3 consecutive periods: a screening period of up to 48 hours, a 2-week investigational medicinal product (IMP) treatment period and a follow-up period of up to 7 weeks after last IMP intake.
All subjects went through a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and samples for future exploratory analysis were obtained at the screening visit.
The trial duration for an individual subject was not exceeded 9 weeks.
- Conditions
- COVID-19
- Being tested
- C21, Placebo
- 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 | Experimental | 50 mg capsules, oral administration twice daily,for 14 days Receives: Drug: C21 |
| Placebo | Placebo comparator | placebo capsules, oral administration twice daily,for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality up to Day 60
Proportion of subjects in the mITT (all randomised, including 5 subjects not treated) with death up to Day 60 follow-up
Measured: Day 1 to Day 60
Secondary outcomes (4)
Time to Sustained Hospital Discharge up to Day 60
Time to sustained hospital discharge from Day 1 to Day 60: Time to sustained hospital discharge was defined as the time to the date of discharge from the initial hospitalization or re-hospitalization due to COVID-19 after which the subject was not re-hospitalized for COVID-19 related reasons.
Measured: Day 1 to Day 60
Supplemental Oxygen-free Days up to Day 29
Supplemental oxygen-free days from Day 1 up to Day 29, observed range 0 to 28 days. Subjects with deaths imputed as -1 day according to SAP and FDA guidance. Outcome was identical in both groups for both median and range
Measured: Day 1 to Day 29, maximum 28 Days
Proportion of Subjects Free of Respiratory Failure, Defined as an 8-point Ordinal Scale Score ≤5, at Day 15
Proportion of subjects free of respiratory failure, defined as an 8-point ordinal scale score ≤5, at Day 15. Missing data imputed by MI, proportion given are average over the imputations.
Measured: Day 15
Proportion of Subjects Discharged From Hospital and Free of Supplemental Oxygen at Day 15
Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15. Missing data imputed by MI, proportion given are average over the imputations.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start16 Sep 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicore Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maureen Horton, MD, Principal investigator, Johns Hopkins University School of Medicine, Baltimore, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880642
- Sponsor's protocol ID
- VP-C21-008
- Other IDs
- 2021-000264-29
- Acronym
- ATTRACT-3
- Status last verified
- Dec 2023
- First submitted
- 28 Apr 2021
- Last updated
- 14 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 3, Multicenter Trial Investigating the Efficacy and Safety of C21 as add-on to Standard of Care in Adult Subjects With COVID-19
- ClinicalTrials.gov ID
- NCT04880642
- Acronym / sponsor ID
- ATTRACT-3 / VP-C21-008
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Vicore Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Posted 14 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a randomized, double-blind, placebo-controlled, parallel-group, 2-arm, multicenter trial to evaluate the efficacy and safety of C21 versus placebo as add-on to standard of care (SoC) in adult subjects with COVID-19.
The trial planned to enroll a total of maximum 300 randomized subjects, 150 per arm (oral C21 100 mg twice a day (BID) or placebo for 14 days) according to the 1:1 randomization.
Detailed description
The trial consists of 3 consecutive periods: a screening period of up to 48 hours, a 2-week investigational medicinal product (IMP) treatment period and a follow-up period of up to 7 weeks after last IMP intake.
All subjects went through a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and samples for future exploratory analysis were obtained at the screening visit.
The trial duration for an individual subject was not exceeded 9 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C21 | Experimental | Drug: C2150 mg capsules, oral administration twice daily,for 14 days |
| Placebo | Placebo comparator | Drug: Placeboplacebo capsules, oral administration twice daily,for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years or the legal age of consent in the jurisdiction in which the trial was taking place at the time of signing the informed consent (Specific for India; Age ≥18 to ≤65 years at the time of signing the informed consent)
- Hospitalized due to SARS-CoV-2 infection confirmed by a hospital-approved polymerase chain reaction (PCR) test, documented by either of the following:
- A score of 5 or 6 on the 8-point ordinal scale:
- Contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies and according to Appendix 3 in the Protocol (see Section 10.3)
- Written informed consent, consistent with International Council for Harmonization Good Clinical Practice Revision 2 and local laws, obtained before the initiation of any trial-related procedure
Key exclusion criteria (20 listed)
- Concurrent serious medical condition which in the opinion of the investigator constituted a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation
- Known, active tuberculosis, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 count<500 cells/mm³).
- Moderate or severe impairment of hepatic function (e.g., Child-Pugh class B or C where alterations in the score components were not due to another underlying disease (see Section 8.4.5 in the Protocol)).
- Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR)≤30 ml/min/1.73m2)
- COVID-19 symptom onset >21 days prior to screening (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 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
All-cause Mortality up to Day 60
Time frame: Day 1 to Day 60
Proportion of subjects in the mITT (all randomised, including 5 subjects not treated) with death up to Day 60 follow-up
4 secondary outcomes
Time to Sustained Hospital Discharge up to Day 60
Time frame: Day 1 to Day 60
Supplemental Oxygen-free Days up to Day 29
Time frame: Day 1 to Day 29, maximum 28 Days
Proportion of Subjects Free of Respiratory Failure, Defined as an 8-point Ordinal Scale Score ≤5, at Day 15
Time frame: Day 15
Proportion of Subjects Discharged From Hospital and Free of Supplemental Oxygen at Day 15
Time frame: Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Maureen Horton, MD principal investigator
Johns Hopkins University School of Medicine, Baltimore, USA
60 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing C21 in people with COVID-19, run by Vicore Pharma AB at 60 sites in 10 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 12 inclusion and 20 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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in India, Ukraine, Brazil, Philippines, United States and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 14 Dec 2023). 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?
All-cause Mortality up to Day 60 (time frame: Day 1 to Day 60). 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 14 Dec 2023.