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

Sponsor
Vicore Pharma AB (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04880642
Collaborator
(none)
300
Enrollment
61
Locations
2
Arms
14.5
Anticipated Duration (Months)
4.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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 maximum 300 randomized subjects, 150 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
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 16, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. All-cause mortality up to Day 60 [Day 60]

Secondary Outcome Measures

  1. Time to sustained hospital discharge up to Day 60 [Day 60]

  2. Supplemental oxygen free days up to Day 29 [Day 29]

  3. Proportion of subjects free of respiratory failure, defined as an 8-point ordinal scale score ≤5, at Day 15 [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 [Day 15]

Other Outcome Measures

  1. Number of adverse events [Day 29]

  2. Number of serious adverse events [Day 60]

  3. Number of withdrawals due to Adverse events [Day 29]

  4. Proportion of subjects discharged from hospital and free of supplemental oxygen [Day 8]

  5. Proportion of subjects discharged from hospital and free of supplemental oxygen [Day 22]

  6. Proportion of subjects discharged from hospital and free of supplemental oxygen [Day 29]

  7. Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO) or supplemental oxygen use [Day 8]

  8. Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, ECMO or supplemental oxygen use [Day 15]

  9. Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, ECMO or supplemental oxygen use [Day 22]

  10. Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, ECMO or supplemental oxygen use [Day 29]

  11. Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, ECMO or supplemental oxygen use [Day 60]

  12. Proportion of subjects in each category of the 8-point ordinal scale [Day 8]

  13. Proportion of subjects in each category of the 8-point ordinal scale [Day 15]

  14. Proportion of subjects in each category of the 8-point ordinal scale [Day 22]

  15. Proportion of subjects in each category of the 8-point ordinal scale [Day 29]

  16. Proportion of subjects in each category of the 8-point ordinal scale [Day 60]

  17. Duration of hospitalization, including re-hospitalization [Day 60]

  18. Proportion of subjects needing intensive care unit stay [Day 8]

  19. Proportion of subjects needing intensive care unit stay [Day 15]

  20. Proportion of subjects needing intensive care unit stay [Day 22]

  21. Proportion of subjects needing intensive care unit stay [Day 29]

  22. Proportion of subjects needing intensive care unit stay [Day 60]

  23. Duration of intensive care unit stay, including re-admission [Day 60]

  24. Proportion of subjects on invasive mechanical ventilation or ECMO [Day 8]

  25. Proportion of subjects on invasive mechanical ventilation or ECMO [Day 15]

  26. Proportion of subjects on invasive mechanical ventilation or ECMO [Day 22]

  27. Proportion of subjects on invasive mechanical ventilation or ECMO [Day 29]

  28. Proportion of subjects on invasive mechanical ventilation or ECMO [Day 60]

  29. Duration of use of invasive mechanical ventilation or ECMO up to Day 60 [Day 60]

  30. All-cause mortality [Day 8]

  31. All-cause mortality [Day 15]

  32. All-cause mortality [Day 22]

  33. All-cause mortality [Day 29]

  34. Change from baseline in oxygen saturation/ fraction of inspired oxygen [Day 15]

  35. Change from baseline in C-reactive protein concentration [Day 15]

  36. Change from baseline in lactate dehydrogenase (LDH) [Day 15]

  37. Proportion of subjects free of respiratory failure [Day 8]

  38. Proportion of subjects free of respiratory failure [Day 22]

  39. Proportion of subjects free of respiratory failure [Day 29]

  40. Proportion of subjects free of respiratory failure [Day 60]

  41. Proportion of respiratory failure free days up to Day 60 [Day 60]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  3. Polymerase chain reaction (PCR) positive in sample collected <72 hours prior to randomization (Visit 2); OR

  4. 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

  5. A score of 5 or 6 on the 8-point ordinal scale:

  6. Score 5: Hospitalized, requiring supplemental oxygen

  7. Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen device

  8. Contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies

  9. 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

  10. 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:

  13. Strong Cytochrome P450 (CYP) 3A4 inducers.

  14. P-glycoprotein (P-gp) substrates with narrow therapeutic index.

  15. High dose Breast Cancer Resistance Protein (BCRP) sensitive substrates.

  16. Warfarin.

  17. Sulphasalazine or rosuvastatin.

  18. 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

  19. Positive pregnancy test

  20. Abnormal laboratory value at screening indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California Irvine Medical Center Orange California United States 92868
2 Northwestern Medicine Central DuPage Hospital Winfield Illinois United States 60190
3 Parkview Physicians Group - Infectious Diseases Fort Wayne Indiana United States 46805
4 Johns Hopkins Baltimore Maryland United States 21218
5 Trinity Health Minot North Dakota United States 58701
6 Lehigh Valley Hospital - 17th Street Allentown Pennsylvania United States 18102
7 Lowcountry Infectious Diseases Charleston South Carolina United States 29414
8 Houston Methodist Hospital Houston Texas United States 77030
9 Carilion Roanoke Memorial Hospital Roanoke Virginia United States 24014
10 Instituto Médico Río Cuarto Río Cuarto Córdoba Argentina X5800
11 Hospital Italiano Rosario - Centro Rosario Santa Fe Argentina S2000
12 Hospital Italiano Rosario Rosario Santa Fe Argentina S2001
13 Nuevo Hospital San Roque Córdoba Argentina
14 Hospital das Clínicas da Faculdade de Medicina de Botucatu Botucatu Brazil
15 Hospital Brasília Brasília Brazil 71681-603
16 Fundação Universidade de Caxias do Sul Caxias Do Sul Brazil
17 Centro de Pesquisas Clínicas de Natal Natal Brazil 59025-050
18 Hospital de Clínicas de Porto Alegre Porto Alegre Brazil
19 Hospital Alemão Oswaldo Cruz - Paulista São Paulo Brazil 01323-020
20 Clinica Somer Medellín Antioquia Colombia
21 Fundación Santa Fe de Bogotá Bogotá Cundinamarca Colombia
22 Hospital Universitario San Ignacio Bogotá Cundinamarca Colombia
23 Fakultní Nemocnice u sv. Anny v Brne Number 1 Brno Czechia
24 Fakultní Nemocnice u sv. Anny v Brně Brno Czechia
25 Nemocnice Slaný Slaný Czechia
26 Masarykova nemocnice v Ústí nad Labem Ústí Nad Labem Czechia
27 Chettinad Hospital and Research Institute Mahabalipuram Chennai India
28 Civil Hospital and B J Medical College Ahmedabad Gujarat India
29 Smt. Kashibai Navale Medical College and General Hospital Pune Gujarat India
30 Rhythm Heart Institute Vadodara Gujarat India
31 Malabar Medical College Hospital and Research Centre Kozhikode Kerala India
32 Dr. SMCSI Medical college, Thiruvananthapuram Kerala India
33 Elite Mission Hospital Thrissur Kerala India
34 Chirayu Medical College and Hospital Bhopal Madhya Pradesh India
35 Government Medical College and Hospital Nagpur Maharashtra India
36 Noble Hospital PVT LTD Pune Maharashtra India
37 Ruby Hall Clinic Pune Maharashtra India
38 Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaja Hospital Thāne Maharashtra India
39 Jawaharlal Nehru Institute of Medical Sciences Imphal Manipur India
40 Southern Philippines Medical Center Davao City Philippines
41 West Visayas State University Medical Center Iloilo City Philippines
42 Makati Medical Center Makati Philippines
43 The Medical City Pasig Philippines
44 Lung Center of the Philippines Quezon City Philippines
45 Quirino Memorial Medical Center Quezon City Philippines
46 St. Luke's Medical Center - Global City Taguig Philippines
47 Clinical Infectious Disease Hospital 1 of the Moscow Department of Health Moscow Russian Federation
48 Alexandrovskaya state hospital Saint Petersburg Russian Federation
49 City hospital #40 Saint Petersburg Russian Federation
50 Nikolaevskaya state hospital Saint Petersburg Russian Federation
51 Pokrovskaya City Hospital Saint Petersburg Russian Federation
52 Mediclinic Southern Africa Tongaat KwaZulu-Natal South Africa 4400
53 TASK Eden George Western Cape South Africa 6530
54 Tygerberg Hospital Tygerberg Hills Western Cape South Africa 7505
55 Zaporizhzhia Regional Clinical Hospital Zaporizhia Saporosje Ukraine
56 City Clinical Hospital №4" of the Dnipro City Council Dnipro Ukraine
57 City Clinical Hospital №13" Of Kharkiv City Council Kharkiv Ukraine
58 Regional Clinical Hospital of Infectious Diseases Kharkiv Ukraine
59 Oleksandrivska Kyiv City Clinical Hospital Kyiv Ukraine
60 Vinnytsia City Clinical Hospital №1 Vinnytsia Ukraine
61 Hospital №1 of Zhytomyr City Council Zhytomyr Ukraine

Sponsors and Collaborators

  • Vicore Pharma AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vicore Pharma AB
ClinicalTrials.gov Identifier:
NCT04880642
Other Study ID Numbers:
  • VP-C21-008
First Posted:
May 11, 2021
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
COVID-19

Study Results

No Results Posted as of Aug 16, 2022