COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04395456

Not reported

Not reported

2020-05-20

Unknown

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: diagnosed with acute respiratory distress syndrome due to sars-cov-2 infection (severe covid-19), according to the following criteria: demonstration of sars-cov-2 rnaemia in nasopharyngeal swap or bronchio-alveolar lavage (bal) a ratio of the partial pressure of oxygen (pao2) to the fraction of inspired oxygen (fio2), pao2/fio2, ≤300 mmhg mild ards (pao2/fio2, ≤300 and >200 mm hg); moderate ards (pao2/fio2, ≤200 and >100 mm hg); severe ards (pao2/fio2, ≤100 mm hg); pulmonary infiltrates suggestive of sars-cov-2-related ards: e.g., bilateral infiltrates at chest x-ray or b-lines at lung us scan. dated and signed informed consent from patient or legal represantative.

- intubated patients - demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or procalcitonin ≥0.25 µg/l) - demonstrated local extrapulmonary abscess - ards due to cardiac failure or fluid overload - concomitant treatment with immunomodulatory /immunosuppressive drugs , which have potential activity against the disease - multi organ failure (mof) - severe renal failure (ckd, by defition glomerular filtration rate <30 ml/min) - neisseria meningitidis infection that is not resolved - current treatment with a complement inhibitor - intravenous immunoglobulin (ivig) within 3 weeks prior to screening - participation in another interventional treatment study within 30 days before initiation of the study treatment (day 1 in this study) or within 5 half-lives of that investigational product, whichever is greater. - chemotherapy for less than 3months - pregnancy - age <18.

2

Amyndas Pharmaceuticals S.A.

18

None

None

Severe disease at enrollment

6: Severe disease at enrollment

144

The proportion of patients assigned to each category, of a six-category ordinal scale.;The proportion of patients who are alive, without evidence of ARDS (i.e. PaO2/FIO2 >300 mm Hg), who do not require any oxygen support (in room air).

None

Phase 2

[{"arm_notes": "", "treatment_id": 81, "treatment_name": "Amy-101", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]