COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04830020

Not reported

Not reported

2021-04-02

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - age ≥ 18 - diagnosis of covid19 by validated sars-cov-2 antigen, rt-pcr, or other molecular diagnostic assay, using an appropriate sample such as np, nasal, oropharyngeal [op], or saliva) and no alternative explanation for current clinical condition. - respiratory failure requiring oxygen therapy - has symptoms consistent with covid-19, and is in non-fibroproliferative stage of disease, as determined by investigator.

- respiratory arrest or the need for immediate intubation; - upper airway obstruction; - facial trauma; - inability to cooperate (e.g. agitation or dementia) - inability to give informed consent - participation in another study for covid19 treatments - deterioration due to other reasons than progressive covid19 pneumonia per clinical judgment, e.g. pulmonary thromboembolism, heart failure, renal failure etc. - palliative care or expectation that patient will not survive > 72 hours post randomization per clinical judgment of the investigator.

2

Campus Bio-Medico University

18

100

Italy

Critical disease at enrollment

8: Critical disease at enrollment

180

Cumulative time on oxygen

None

Phase 2

[{"arm_notes": " ", "treatment_id": 581, "treatment_name": "High-molecular weight hyaluronan (hmw-ha)", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": " ", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]