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

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04880642

Run by

Vicore Pharma AB

People needed

272

Starts

2021-09-16

Expected to finish

2022-04-25

Last updated by the study team

2023-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• 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.

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.
• Warfarin.
• Sulphasalazine or rosuvastatin.
• 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).
• Positive pregnancy test (see Section 8.4.6 in the Protocol).
• Abnormal laboratory value at screening (Visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator

Where it is running

• 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
• University of California Irvine Medical Center — Orange, California, United States

Full record on ClinicalTrials.gov

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