Status:
COMPLETED
A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects
Lead Sponsor:
Vicore Pharma AB
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2022
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT04880642
Start Date
September 16 2021
End Date
April 25 2022
Last Update
December 14 2023
Active Locations (60)
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1
University of California Irvine Medical Center
Orange, California, United States, 92868
2
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, United States, 60190
3
Parkview Physicians Group - Infectious Diseases
Fort Wayne, Indiana, United States, 46805
4
Trinity Health
Minot, North Dakota, United States, 58701