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A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects
Phase 3 trial testing C21 in COVID-19 in 272 participants. Completed in 25 April 2022.
| Lead sponsor | Vicore Pharma AB |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 272 |
| Start date | 16 September 2021 |
| Primary completion | 25 April 2022 |
| Estimated completion | 25 April 2022 |
| Sites | 60 locations across Colombia, South Africa, Russia, Ukraine, India, Philippines, Argentina, United States |
Vicore Pharma AB — full company profile →
18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of subjects in the mITT (all randomised, including 5 subjects not treated) with death up to Day 60 follow-up
| Group | Value | 95% CI |
|---|---|---|
| C21 Treatment | 10 | |
| Placebo Treatment | 10 |
| Group | Value | 95% CI |
|---|---|---|
| C21 Treatment | 126 | |
| Placebo Treatment | 126 |
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.
| Group | Value | 95% CI |
|---|---|---|
| C21 Treatment | 9.0 | 7.0 – 11.0 |
| Placebo Treatment | 9.0 | 8.0 – 11.0 |
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
| Group | Value | 95% CI |
|---|---|---|
| C21 Treatment | 23.0 | -1 – 28 |
| Placebo Treatment | 23.0 | -1 – 28 |
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.
| Group | Value | 95% CI |
|---|---|---|
| C21 Treatment | 0.884 | |
| Placebo Treatment | 0.901 |
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.
| Group | Value | 95% CI |
|---|---|---|
| C21 Treatment | 0.676 | |
| Placebo Treatment | 0.679 |
Time frame: Adverse events were collected from signing of informed consent until day 29 (visit 31 in the follow-up period). Serious adverse events were collected from signing of informed consent until day 60 (visit 32 in the follow-up period). Adverse events occurring after the first Investigational Medical Product (IMP) intake were considered treatment-emergent adverse events (TEAEs) in the statistical analysis.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | C21 Treatment | Placebo Treatment |
|---|---|---|---|
| Cardiac failure acute | Cardiac disorders | — | — |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | — | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| COVID-19 | Infections and infestations | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Cardio-respiratory arrest | Cardiac disorders | — | — |
| Cor pulmonale | Cardiac disorders | — | — |
| Frederick's syndrome | Cardiac disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — |
| Septic shock | Infections and infestations | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Lymphadenitis | Blood and lymphatic system disorders | — | — |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Accelerated hypertension | Vascular disorders | — | — |
| Death | General disorders | — | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — | — |
| Reaction | System | C21 Treatment | Placebo Treatment |
|---|---|---|---|
| Alanine aminotransferase increased | Investigations | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Asthenia | General disorders | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — |
Most-reported serious reactions: Cardiac failure acute, Acute respiratory distress syndrome, Acute respiratory failure, Pulmonary embolism, Respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Epistaxis.
Data from ClinicalTrials.gov NCT04880642 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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