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

COVID-19 Clinical Trial

— ATTRACT-3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04880642
• Other study ID #: VP-C21-008
• Secondary ID: 2021-000264-29
• Status: Completed
• Phase: Phase 3
• Start date: September 16, 2021
• Est. completion date: April 25, 2022

Study information

• Verified date: December 2023
• Source: Vicore Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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)

2. Hospitalized due to SARS-CoV-2 infection confirmed by a hospital-approved polymerase chain reaction (PCR) test, documented by either of the following:

1. 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 and according to Appendix 3 in the Protocol (see Section 10.3)

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 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:

7. 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.

Exclusion Criteria:

1. 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

2. Known, active tuberculosis, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 count<500 cells/mm³).

3. 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)).

4. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR)=30 ml/min/1.73m2)

5. COVID-19 symptom onset >21 days prior to screening (Visit 1).

6. Hospitalized due to COVID-19 for >72 hours at screening (Visit 1).

7. Invasive mechanical ventilation or ECMO within 72 hours of screening (Visit 1).

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., 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.

10. Pregnant or breast-feeding female subjects

11. Any previous and concurrent experimental treatment for COVID-19 that was not considered local SoC.

12. 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:

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 had received a dose of IMP within 1 month or 5 half-lives of the IMP, whichever was longest, prior to screening (Visit 1).

14. Positive pregnancy test (see Section 8.4.6 in the Protocol).

15. Abnormal laboratory value at screening (Visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• C21
C21
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Nuevo Hospital San Roque	Córdoba
Argentina	Instituto Médico Río Cuarto	Río Cuarto	Córdoba
Argentina	Hospital Italiano Rosario	Rosario	Santa Fe
Argentina	Hospital Italiano Rosario - Centro	Rosario	Santa Fe
Brazil	Hospital das Clínicas da Faculdade de Medicina de Botucatu	Botucatu
Brazil	Hospital Brasília	Brasília
Brazil	Fundação Universidade de Caxias do Sul	Caxias Do Sul
Brazil	Centro de Pesquisas Clínicas de Natal	Natal
Brazil	Instituto Atena de Pesquisa Clínica	Natal	Rio Grande Do Norte
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre
Brazil	Hospital Alemão Oswaldo Cruz - Paulista	São Paulo
Colombia	Fundación Santa Fe de Bogotá	Bogotá	Cundinamarca
Colombia	Hospital Universitario San Ignacio	Bogotá	Cundinamarca
Colombia	Clinica Somer	Rionegro	Antioquia
Czechia	Fakultní Nemocnice u sv. Anny v Brne II. Interní Klinika kardiologická JIP,	Brno	South Moravian
Czechia	Fakultní Nemocnice u sv. Anny v Brne Number 1	Brno
Czechia	Nemocnice Slaný	Slaný
Czechia	Masarykova nemocnice v Ústí nad Labem	Ústí Nad Labem
India	Civil Hospital and B J Medical College	Ahmedabad	Gujarat
India	Chirayu Medical College and Hospital	Bhopal	Madhya Pradesh
India	Jawaharlal Nehru Institute of Medical Sciences	Imphal	Manipur
India	Malabar Medical College Hospital and Research Centre	Kozhikode	Kerala
India	Chettinad Hospital and Research Institute	Mahabalipuram	Chennai
India	Government Medical College and Hospital	Nagpur	Maharashtra
India	Meditrina Institute of Medical Sciences	Nagpur	Maharashtra
India	Noble Hospital	Pune	Maharashtra
India	Ruby Hall Clinic	Pune	Maharashtra
India	Smt. Kashibai Navale Medical College and General Hospital	Pune	Gujarat
India	Rajiv Gandhi Medical College	Thane	Maharashtra
India	Elite Mission Hospital	Thrissur	Kerala
India	Rhythm Heart Institute	Vadodara	Gujarat
Philippines	Southern Philippines Medical Center	Davao City
Philippines	The Medical City	Iloilo City	Iloilo
Philippines	West Visayas State University Medical Center	Iloilo City
Philippines	Makati Medical Center	Makati
Philippines	Lung Center of the Philippines	Quezon City
Philippines	Quirino Memorial Medical Center	Quezon City
Philippines	St. Luke's Medical Center - Global City	Taguig
Russian Federation	Clinical Infectious Disease Hospital 1 of the Moscow Department of Health	Moscow
Russian Federation	Alexandrovskaya State Hospital	Saint Petersburg
Russian Federation	Nikolaevskaya State Hospital	Saint Petersburg
Russian Federation	Pokrovskaya City Hospital	Saint Petersburg
Russian Federation	St. Petersburg State Budgetary Healthcare Institution City Hospital Number 40 of the Kurortny District	Saint Petersburg
South Africa	TASK Eden	George	Western Cape
South Africa	Mediclinic Southern Africa	Tongaat	KwaZulu-Natal
South Africa	Tygerberg Hospital	Tygerberg Hills	Western Cape
Ukraine	City Clinical Hospital ?6 of the Dnipro City Council	Dnipropetrovs'k
Ukraine	City Clinical Hospital ?13" Of Kharkiv City Council	Kharkiv
Ukraine	Regional Clinical Hospital of Infectious Diseases	Kharkiv
Ukraine	Kyiv city clinical hospital number 12	Kiev
Ukraine	Oleksandrivska Kyiv City Clinical Hospital	Kyiv
Ukraine	Vinnytsia City Clinical Hospital ?1	Vinnytsia
Ukraine	Zaporizhzhia Regional Clinical Hospital	Zaporizhia	Zaporizhzhia
Ukraine	Hospital ?1 of Zhytomyr City Council	Zhytomyr
United States	Lehigh Valley Hospital - 17th Street	Allentown	Pennsylvania
United States	Parkview Physicians Group - Infectious Diseases	Fort Wayne	Indiana
United States	Trinity Health	Minot	North Dakota
United States	University of California Irvine Medical Center	Orange	California
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Northwestern Medicine Central DuPage Hospital	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Vicore Pharma AB

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Colombia,  Czechia,  India,  Philippines,  Russian Federation,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1 to Day 60
Secondary	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.	Day 1 to Day 60
Secondary	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	Day 1 to Day 29, maximum 28 Days
Secondary	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.	Day 15
Secondary	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.	Day 15