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

NCT ID: NCT04880642

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2022-04-25

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 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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

C21

50 mg capsules, oral administration twice daily,for 14 days

Group Type: EXPERIMENTAL

C21

Intervention Type: DRUG

C21

Placebo

placebo capsules, oral administration twice daily,for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

C21

C21

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vicore Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maureen Horton, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University School of Medicine, Baltimore, USA

Locations

University of California Irvine Medical Center

Orange, California, United States

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, United States

Parkview Physicians Group - Infectious Diseases

Fort Wayne, Indiana, United States

Trinity Health

Minot, North Dakota, United States

Lehigh Valley Hospital - 17th Street

Allentown, Pennsylvania, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Hospital Italiano Rosario - Centro

Rosario, Santa Fe Province, Argentina

Hospital Italiano Rosario

Rosario, Santa Fe Province, Argentina

Nuevo Hospital San Roque

Córdoba, , Argentina

Instituto Atena de Pesquisa Clínica

Natal, Rio Grande do Norte, 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

Hospital de Clínicas de Porto Alegre

Porto Alegre, , Brazil

Hospital Alemão Oswaldo Cruz - Paulista

São Paulo, , Brazil

Clinica Somer

Rionegro, Antioquia, Colombia

Fundación Santa Fe de Bogotá

Bogotá, Cundinamarca, Colombia

Hospital Universitario San Ignacio

Bogotá, Cundinamarca, Colombia

Fakultní Nemocnice u sv. Anny v Brně 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, , Czechia

Chettinad Hospital and Research Institute

Mahabalipuram, Chennai, India

Civil Hospital and B J Medical College

Ahmedabad, Gujarat, India

Smt. Kashibai Navale Medical College and General Hospital

Pune, Gujarat, India

Rhythm Heart Institute

Vadodara, Gujarat, India

Malabar Medical College Hospital and Research Centre

Kozhikode, Kerala, India

Elite Mission Hospital

Thrissur, Kerala, India

Chirayu Medical College and Hospital

Bhopal, Madhya Pradesh, 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

Rajiv Gandhi Medical College

Thāne, Maharashtra, India

Jawaharlal Nehru Institute of Medical Sciences

Imphal, Manipur, India

The Medical City

Iloilo City, Iloilo, Philippines

St. Luke's Medical Center - Global City

City of Taguig, , Philippines

Southern Philippines Medical Center

Davao City, , 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

Clinical Infectious Disease Hospital 1 of the Moscow Department of Health

Moscow, , Russia

Alexandrovskaya State Hospital

Saint Petersburg, , Russia

Nikolaevskaya State Hospital

Saint Petersburg, , Russia

Pokrovskaya City Hospital

Saint Petersburg, , Russia

St. Petersburg State Budgetary Healthcare Institution City Hospital Number 40 of the Kurortny District

Saint Petersburg, , Russia

Mediclinic Southern Africa

Tongaat, KwaZulu-Natal, South Africa

TASK Eden

George, Western Cape, South Africa

Tygerberg Hospital

Tygerberg Hills, Western Cape, South Africa

Zaporizhzhia Regional Clinical Hospital

Zaporizhia, Zaporizhzhia Oblast, Ukraine

City Clinical Hospital №6 of the Dnipro City Council

Dnipro, , 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

Hospital №1 of Zhytomyr City Council

Zhytomyr, , Ukraine

Countries

Peru; United States; Argentina; Brazil; Colombia; Czechia; India; Philippines; Russia; South Africa; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-000264-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VP-C21-008

Identifier Type: -

Identifier Source: org_study_id