Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT04500418
Eligibility Criteria:
Inclusion Criteria:
* Subject provides written informed consent prior to initiation of any study procedures. Understands and agrees to comply with planned study procedures.
* Male or non-pregnant female adult ≥18 years of age at time of enrolment.
* Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR and fulfils the case criteria of COVID-19 (One or more of the following must be met in lieu of a positive PCR test: fever \[defined as a temperature ≥ 100.0°F / 37.8°C documented within 24 hr. of randomization\] , absolute and relative lymphopenia and leukopenia, new typical infiltrates in x-ray of the chest or chest CT scan \[only if obtained for clinical reasons; not required by study\], no improvement on antibiotics).
* Scoring a "3" or "4" (or "5", at the Investigator's discretion) on the 7-Point Ordinal Scale (see Outcome Measures) at enrolment. Note, if scoring a "2" at screening, inclusion will be met if the patient is in the process of being hospitalized or admitted to an inpatient setting. Such a patient would be assigned a "3" at enrolment for Baseline assessment purposes.
* No participation in other clinical trials according to the German Medicines Act (AMG) (3 months before) at the time of this trial.
Exclusion Criteria:
* ALT/AST \> 5 times the upper limit of normal.
* Patients with severe hepatic impairment (defined as liver cirrhosis Child stage B or C)
* Stage 4 chronic kidney disease or requiring dialysis (i.e. eGFR \< 30 ml/min)
* Advanced cardiac (eg, severe heart failure \[NYHA III-IV\]) or pulmonary diseases which, in the Investigator's judgment, would not make participation appropriate.
* Pregnancy or breast feeding.
* Anticipated transfer to another hospital which is not a study site within 72 hours.
* Known allergy or hypersensitivity to CVC or its components.
* Use of medications that are contraindicated with CVC and that could not be replaced or stopped during the trial period
* Administration of specified drugs which interfere with the metabolism of CVC.
* Patients immediately or imminently requiring mechanical ventilation.
* Patients unwilling to consent to saving and propagation of pseudonymised medical data for study reasons.
* Subjects who are legally detained in an official institution.
* Subjects that are unsuitable to understand or to comply with the study requirements in the opinion of the investigator.
* Subjects who may be dependent on the sponsor, the investigator or the trial sites.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04500418
Study Brief:
Protocol Section:
NCT04500418