COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04500418

Frank Tacke

Not reported

2020-08-05

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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.

- 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.

2

Charite University, Berlin, Germany

18

100

Germany

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

45

Subject´s Responder status (score on the 7-point ordinal scale on Day 15)

None

Phase 2

[{"arm_notes": "", "treatment_id": 263, "treatment_name": "Cenicriviroc", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]