COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04429555

Kazuko Matsuda

Not reported

2020-06-12

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - sars-cov-2 infection confirmed with who criteria (including a positive pcr of any specimen, e.g., blood, respiratory, stool, urine, or any other body fluid) - chest imaging (radiograph, ct scan or lung ultrasound) with abnormalities consistent with covid-19 pneumonia - spo2 ≤ 92% on room air (ra), rr ≥24 breaths per min on ra, and/or requirement for supplemental oxygen - at least 1 risk factor which may put patient at higher risk for more severe illness from covid-19: age > 65, underlying serious heart disease, chronic lung disease, moderate to severe asthma, body mass index of ≥ 40 or diabetes

- suspected active bacterial, fungal, viral, or other cause of respiratory failure other than covid-19 - subject is already intubated and on ventilator support - known or suspected immunosuppression with immunosuppressant medications or chemotherapeutic agents - subject is on dialysis - on home ventilator support or continuous domiciliary o2 therapy for baseline lung disease - active tuberculosis (tb) infection

2

MediciNova

18

80

United States

Severe disease at enrollment

6: Severe disease at enrollment

40

Proportion of subjects free from respiratory failure at Day 7;Proportion of subjects with at least a 1-point improvement in clinical status using the National Institute on Allergy and Infectious Disease 8-point ordinal scale and discharge record at Day 7

None

Phase 2

[{"arm_notes": "", "treatment_id": 618, "treatment_name": "Ibudilast", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]