Phase 3
N=272
A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04880642 ↗Enrolled (actual)
272
Serious AEs
10.5%
Results posted
Dec 2023
Primary outcome: Primary: All-cause Mortality up to Day 60 — 10; 10; 126; 126 Participants — p=0.949
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- C21 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vicore Pharma AB
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality up to Day 60 |
10; 10; 126; 126 | 0.949 |
| SECONDARY Time to Sustained Hospital Discharge up to Day 60 |
9.0; 9.0 | 0.301 |
| SECONDARY Supplemental Oxygen-free Days up to Day 29 |
23.0; 23.0 | 0.425 |
| SECONDARY Proportion of Subjects Free of Respiratory Failure, Defined as an 8-point Ordinal Scale Score ≤5, at Day 15 |
0.884; 0.901 | 0.671 |
| SECONDARY Proportion of Subjects Discharged From Hospital and Free of Supplemental Oxygen at Day 15 |
0.676; 0.679 | 0.948 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 93% and respiratory rate 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
Data sourced from ClinicalTrials.gov (NCT04880642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.