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

NCT04880642 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: VP-C21-0082021-000264-29
• Study Type: interventional
• Target: 272
• Locations: 10 countries
• Sites: 60

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to Sustained Hospital Discharge up to Day 60

  Day 1 to Day 60

• Supplemental Oxygen-free Days up to Day 29

  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

  Day 15

• Proportion of Subjects Discharged From Hospital and Free of Supplemental Oxygen at Day 15

  Day 15

Study Arms (2)

C21

EXPERIMENTAL

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

Drug: C21

Placebo

PLACEBO COMPARATOR

placebo capsules, oral administration twice daily,for 14 days

Drug: Placebo

Interventions

C21 DRUG

C21

C21

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Vicore Pharma AB: lead

Study Sites (60)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

Parkview Physicians Group - Infectious Diseases

Fort Wayne, Indiana, 46805, United States

Location

Trinity Health

Minot, North Dakota, 58701, United States

Location

Lehigh Valley Hospital - 17th Street

Allentown, Pennsylvania, 18102, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, X5800, Argentina

Location

Hospital Italiano Rosario - Centro

Rosario, Santa Fe Province, S2000, Argentina

Location

Hospital Italiano Rosario

Rosario, Santa Fe Province, S2001, Argentina

Location

Nuevo Hospital San Roque

Córdoba, Argentina

Location

Instituto Atena de Pesquisa Clínica

Natal, Rio Grande do Norte, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, Brazil

Location

Hospital Brasília

Brasília, 71681-603, Brazil

Location

Fundação Universidade de Caxias do Sul

Caxias do Sul, Brazil

Location

Centro de Pesquisas Clínicas de Natal

Natal, 59025-050, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Location

Hospital Alemão Oswaldo Cruz - Paulista

São Paulo, 01323-020, Brazil

Location

Clinica Somer

Rionegro, Antioquia, Colombia

Location

Fundación Santa Fe de Bogotá

Bogotá, Cundinamarca, Colombia

Location

Hospital Universitario San Ignacio

Bogotá, Cundinamarca, Colombia

Location

Fakultní Nemocnice u sv. Anny v Brně II. Interní Klinika kardiologická JIP,

Brno, South Moravian, Czechia

Location

Fakultní Nemocnice u sv. Anny v Brne Number 1

Brno, Czechia

Location

Nemocnice Slaný

Slaný, Czechia

Location

Masarykova nemocnice v Ústí nad Labem

Ústí nad Labem, Czechia

Location

Chettinad Hospital and Research Institute

Mahabalipuram, Chennai, India

Location

Civil Hospital and B J Medical College

Ahmedabad, Gujarat, India

Location

Smt. Kashibai Navale Medical College and General Hospital

Pune, Gujarat, India

Location

Rhythm Heart Institute

Vadodara, Gujarat, India

Location

Malabar Medical College Hospital and Research Centre

Kozhikode, Kerala, India

Location

Elite Mission Hospital

Thrissur, Kerala, India

Location

Chirayu Medical College and Hospital

Bhopal, Madhya Pradesh, India

Location

Government Medical College and Hospital

Nagpur, Maharashtra, India

Location

Meditrina Institute of Medical Sciences

Nagpur, Maharashtra, India

Location

Noble Hospital

Pune, Maharashtra, India

Location

Ruby Hall Clinic

Pune, Maharashtra, India

Location

Rajiv Gandhi Medical College

Thane, Maharashtra, India

Location

Jawaharlal Nehru Institute of Medical Sciences

Imphal, Manipur, India

Location

The Medical City

Iloilo City, Iloilo, Philippines

Location

St. Luke's Medical Center - Global City

City of Taguig, Philippines

Location

Southern Philippines Medical Center

Davao City, Philippines

Location

West Visayas State University Medical Center

Iloilo City, Philippines

Location

Makati Medical Center

Makati, Philippines

Location

Lung Center of the Philippines

Quezon City, Philippines

Location

Quirino Memorial Medical Center

Quezon City, Philippines

Location

Clinical Infectious Disease Hospital 1 of the Moscow Department of Health

Moscow, Russia

Location

Alexandrovskaya State Hospital

Saint Petersburg, Russia

Location

Nikolaevskaya State Hospital

Saint Petersburg, Russia

Location

Pokrovskaya City Hospital

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Mediclinic Southern Africa

Tongaat, KwaZulu-Natal, 4400, South Africa

Location

TASK Eden

George, Western Cape, 6530, South Africa

Location

Tygerberg Hospital

Tygerberg Hills, Western Cape, 7505, South Africa

Location

Zaporizhzhia Regional Clinical Hospital

Zaporizhia, Zaporizhzhia Oblast, Ukraine

Location

City Clinical Hospital №6 of the Dnipro City Council

Dnipro, Ukraine

Location

City Clinical Hospital №13" Of Kharkiv City Council

Kharkiv, Ukraine

Location

Regional Clinical Hospital of Infectious Diseases

Kharkiv, Ukraine

Location

Kyiv city clinical hospital number 12

Kiev, Ukraine

Location

Oleksandrivska Kyiv City Clinical Hospital

Kyiv, Ukraine

Location

Vinnytsia City Clinical Hospital №1

Vinnytsia, Ukraine

Location

Hospital №1 of Zhytomyr City Council

Zhytomyr, Ukraine

Location

MeSH Terms

Conditions

COVID-19

Interventions

compound 21

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: CEO Carl-Johan Dalsgaard
• Organization: Vicore Pharma

info@vicorepharma.com

+46 (0) 317880560

Study Officials

• Maureen Horton, MD

  Johns Hopkins University School of Medicine, Baltimore, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 11, 2021
• Study Start: September 16, 2021
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: December 14, 2023
• Results First Posted: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AR (4); PH (7); US (6); CO (3); RU (5); ZA (3); UA (8); BR (7); CZ (4); IN (13)