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A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects (ATTRACT-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04880642
Recruitment Status : Active, not recruiting
First Posted : May 11, 2021
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Vicore Pharma AB

Brief 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 SoC in adult subjects with COVID-19.

The trial will enroll a total of 600 randomized subjects, 300 per arm (oral C21 100 mg twice a day (b.i.d.) or placebo for 14 days) according to the 1:1 randomization.


Condition or disease Intervention/treatment Phase
Covid19 Drug: C21 Drug: Placebo Phase 3

Detailed Description:

The trial consists of 3 consecutive periods: a screening period of up to 48 hours, a 2-week IMP treatment period and a follow-up period of up to 7 weeks after last IMP intake.

All subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and samples for future exploratory analysis will be obtained at the screening visit.

The trial duration for an individual subject will not exceed 9 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 16, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: C21
50 mg capsules, oral administration twice daily,for 14 days
Drug: C21
C21

Placebo Comparator: Placebo
placebo capsules, oral administration twice daily,for 14 days
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. All-cause mortality up to Day 60 [ Time Frame: Day 60 ]

Secondary Outcome Measures :
  1. Time to sustained hospital discharge up to Day 60 [ Time Frame: Day 60 ]
  2. Supplemental oxygen free days up to Day 29 [ Time Frame: Day 29 ]
  3. Proportion of subjects free of respiratory failure, defined as an 8-point ordinal scale score ≤5, at Day 15 [ Time Frame: Day 15 ]
    1:Not hospitalized, no limitations on activities and 8: Death

  4. Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15 [ Time Frame: Day 15 ]

Other Outcome Measures:
  1. Number of adverse events [ Time Frame: Day 29 ]
  2. Number of serious adverse events [ Time Frame: Day 60 ]
  3. Number of withdrawals due to Adverse events [ Time Frame: Day 29 ]
  4. Proportion of subjects discharged from hospital and free of supplemental oxygen [ Time Frame: Day 8 ]
  5. Proportion of subjects discharged from hospital and free of supplemental oxygen [ Time Frame: Day 22 ]
  6. Proportion of subjects discharged from hospital and free of supplemental oxygen [ Time Frame: Day 29 ]
  7. Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO) or supplemental oxygen use [ Time Frame: Day 8 ]
  8. Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, ECMO or supplemental oxygen use [ Time Frame: Day 15 ]
  9. Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, ECMO or supplemental oxygen use [ Time Frame: Day 22 ]
  10. Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, ECMO or supplemental oxygen use [ Time Frame: Day 29 ]
  11. Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, ECMO or supplemental oxygen use [ Time Frame: Day 60 ]
  12. Proportion of subjects in each category of the 8-point ordinal scale [ Time Frame: Day 8 ]
  13. Proportion of subjects in each category of the 8-point ordinal scale [ Time Frame: Day 15 ]
  14. Proportion of subjects in each category of the 8-point ordinal scale [ Time Frame: Day 22 ]
  15. Proportion of subjects in each category of the 8-point ordinal scale [ Time Frame: Day 29 ]
  16. Proportion of subjects in each category of the 8-point ordinal scale [ Time Frame: Day 60 ]
  17. Duration of hospitalization, including re-hospitalization [ Time Frame: Day 60 ]
  18. Proportion of subjects needing intensive care unit stay [ Time Frame: Day 8 ]
  19. Proportion of subjects needing intensive care unit stay [ Time Frame: Day 15 ]
  20. Proportion of subjects needing intensive care unit stay [ Time Frame: Day 22 ]
  21. Proportion of subjects needing intensive care unit stay [ Time Frame: Day 29 ]
  22. Proportion of subjects needing intensive care unit stay [ Time Frame: Day 60 ]
  23. Duration of intensive care unit stay, including re-admission [ Time Frame: Day 60 ]
  24. Proportion of subjects on invasive mechanical ventilation or ECMO [ Time Frame: Day 8 ]
  25. Proportion of subjects on invasive mechanical ventilation or ECMO [ Time Frame: Day 15 ]
  26. Proportion of subjects on invasive mechanical ventilation or ECMO [ Time Frame: Day 22 ]
  27. Proportion of subjects on invasive mechanical ventilation or ECMO [ Time Frame: Day 29 ]
  28. Proportion of subjects on invasive mechanical ventilation or ECMO [ Time Frame: Day 60 ]
  29. Duration of use of invasive mechanical ventilation or ECMO up to Day 60 [ Time Frame: Day 60 ]
  30. All-cause mortality [ Time Frame: Day 8 ]
  31. All-cause mortality [ Time Frame: Day 15 ]
  32. All-cause mortality [ Time Frame: Day 22 ]
  33. All-cause mortality [ Time Frame: Day 29 ]
  34. Change from baseline in oxygen saturation/ fraction of inspired oxygen [ Time Frame: Day 15 ]
  35. Change from baseline in C-reactive protein concentration [ Time Frame: Day 15 ]
  36. Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Day 15 ]
  37. Proportion of subjects free of respiratory failure [ Time Frame: Day 8 ]
  38. Proportion of subjects free of respiratory failure [ Time Frame: Day 22 ]
  39. Proportion of subjects free of respiratory failure [ Time Frame: Day 29 ]
  40. Proportion of subjects free of respiratory failure [ Time Frame: Day 60 ]
  41. Proportion of respiratory failure free days up to Day 60 [ Time Frame: Day 60 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years or the legal age of consent in the jurisdiction in which the trial is taking place at the time of signing the informed consent
  2. Hospitalized due to Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection confirmed by polymerase chain reaction test, documented by either of the following:

    1. Polymerase chain reaction (PCR) positive in sample collected <72 hours prior to randomization (Visit 2); OR
    2. 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
  3. A score of 5 or 6 on the 8-point ordinal scale:

    1. Score 5: Hospitalized, requiring supplemental oxygen
    2. Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen device
  4. Contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  5. 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
  6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol

Exclusion Criteria:

  1. Concurrent serious medical condition which in the opinion of the investigator constitutes a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation
  2. Known, active hepatitis B, C, or human immunodeficiency virus infection (i.e., human immunodeficiency virus (HIV) with a cluster of differentiation 4 (CD4) count <500 cells/mm³)
  3. Impaired hepatic function (i.e., Child-Pugh class A or B)
  4. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73 m2)
  5. Corona virus disease (COVID)-19 symptom onset >14 days prior to screening
  6. Hospitalized due to COVID-19 for >72 hours at screening
  7. Invasive mechanical ventilation or ECMO within 72 hours of screening
  8. Expected need for invasive mechanical ventilation or ECMO in <48 hours in the opinion of the investigator
  9. Moderate to severe ARDS (e.g., partial pressure of oxygen (PaO2)/FiO2 ≤200 mmHg), if on non-invasive mechanical ventilation or high-flow oxygen
  10. Pregnant or breast-feeding female subjects
  11. Any previous and concurrent experimental treatment for COVID-19 that is not considered local SoC.
  12. Treatment with the medications listed below within 1 week prior to screening or anticipated need for such medication during the participation in this trial:

    1. Strong Cytochrome P450 (CYP) 3A4 inducers.
    2. P-glycoprotein (P-gp) substrates with narrow therapeutic index.
    3. High dose Breast Cancer Resistance Protein (BCRP) sensitive substrates.
    4. Warfarin.
    5. Sulphasalazine or rosuvastatin.
  13. Current or previous participation in any other clinical trial where the subject has received a dose of IMP within 1 month or 5 half-lives of the investigational medicinal product (IMP), whichever is longest, prior to screening
  14. Positive pregnancy test
  15. Abnormal laboratory value at screening indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04880642


Locations
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Sponsors and Collaborators
Vicore Pharma AB
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Responsible Party: Vicore Pharma AB
ClinicalTrials.gov Identifier: NCT04880642    
Other Study ID Numbers: VP-C21-008
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases