COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04358406

Mark J DiNubile

Not reported

2020-04-24

Completed

RCT

Randomized

Single group assignment

Blind label

multi-center

Treatment

inclusion criteria: - hospitalized with laboratory-confirmed (rt-pcr+) or highly suspected (compatible with at least bilobar lung involvement without another plausible diagnosis) covid-19 - weight ≤100 kg - within 24 hours of reaching a who severity score of 4-6 either: - at admission - while already hospitalized - informed consent obtained from subject/next of kin/legal proxy - primary admitting diagnosis of pneumonia supported by a compatible clinical presentation with a documented infiltrate consistent with pneumonia on chest radiograph or ct as assessed by the admitting emergency-department (ed), clinic, or ward physician or equivalent caregiver - recommended (not mandatory) guidance/discretionary criteria defining patients with pneumonia satisfying all 4 categories below: - at least 2 symptoms: difficulty breathing, cough, production of purulent sputum, or chest pain - at least 2 vital sign abnormalities: fever, tachycardia, or tachypnea (thresholds -- fever: oral or core temperature >100.4 °f [38 °c]; heart rate >100 beats/min; respiratory rate >24/min) - at least one finding of other clinical signs and laboratory abnormalities: hypoxemia (o2 saturation <90%), clinical evidence of pulmonary consolidation, or leukocytosis or leukopenia - chest imaging or ct showing new (or presumed new or worsening) pulmonary infiltrates - principal investigator to note radiologic findings in the electronic case report form (ecrf) - radiology report to be placed in the ecrf - a copy of the radiograph attached to be saved for review - a hyperinflammatory status (defined by increased ferritin ≥500 µg/l, d-dimer ≥1000 ng/ml, or c-reactive protein (crp) ≥75 mg/l) - during the course of the study starting at screening and for at least 6 months after their final study treatment: - female subjects of childbearing potential must agree to use 2 medically accepted birth control methods - male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner - all subjects must agree not to donate sperm or eggs (ovocytes)

- a negative rt-pcr test for covid-19 during the evaluation of the present illness - extracorporeal membrane oxygenation (ecmo) - pregnant or lactating women - active underlying cancer treated with systemic chemotherapy or radiation therapy during the last 30 days - transplantation of hematopoietic or solid organs - chronic mechanical ventilation or dialysis - otherwise unsuitable for study participation because of chronic, severe, end-stage, and life-limiting underlying disease unrelated to covid-19 likely to interfere with management and assessment of acute pneumonia, only comfort or limited (non-aggressive) care is to be given, or life expectancy <6 months unrelated to acute covid infection in the opinion of the investigator

2

BioAegis Therapeutics Inc.

18

100

Romania;Spain

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

64

Efficacy: Proportion of Subjects Alive Not on Vasopressors, Mechanical Ventilator, or Dialysis;Safety: Number of Subjects With SAEs

None

Phase 2

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